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Cerebral Palsy (CP)NCT07763691

Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy

A study testing Robot-Assisted Mirror Therapy, Mirror Therapy and Neurodevelopmental Treatment in people with Cerebral Palsy (CP) and Hemiparetic Cerebral Palsy, run by Medipol University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to learn whether robot-assisted mirror therapy improves upper extremity function in children with spastic hemiparetic cerebral palsy. The study will also compare the effects of robot-assisted mirror therapy with those of conventional mirror therapy. Read more about this study

Who is it for?
Ages 6 to 17 years
What is being tested?
Robot-Assisted Mirror Therapy, Mirror Therapy and Neurodevelopmental Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Mar 2025to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children classified within levels I, II, or III of the Gross Motor Function Classification System (GMFCS)
  • Children classified within levels I, II, or III of the Manual Ability Classification System (MACS).
  • Children classified within levels I, II, or III of the Communication Function Classification System (CFCS)
  • Medical records indicating a diagnosis of prenatal, intrapartum, or very early postnatal hemiparetic cerebral palsy, confirmed by neurologists and supported by magnetic resonance imaging (MRI).
  • Being between 6-17 years of age
  • Being able to cooperate
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  • Attending age-appropriate classes
  • Ability to extend the wrist by more than 20 degrees and the metacarpophalangeal joints by more than 10 degrees
  • Ability to voluntarily release objects with the affected hand

Who cannot join

  • Diagnosis of intellectual disability and/or low cognitive level suitable for attending a special education school,
  • Behavioral and adaptation difficulties observed in the child during the administration of study assessments.
  • Diagnosis of attention deficit and/or hyperactivity disorder
  • History of epileptic seizures
  • Upper extremity fracture, muscle-tendon or bone surgery within the past six months, or use of any pharmacological agents to inhibit spasticity, including botulinum toxin administration
  • Uncorrected hearing and/or visual impairment
  • Severe muscle tone in the shoulder, elbow, or wrist, indicated by a Modified Ashworth Scale score greater than 3.
  • Any new treatment planned during the study period

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dilbade Özel Eğitim ve Rehabilitasyon Merkezi

    Istanbul, 34050

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Robot-Assisted Mirror Therapy on Upper Extremity Function in the Rehabilitation of Hemiparetic Cerebral Palsy

The goal of this clinical trial is to learn whether robot-assisted mirror therapy improves upper extremity function in children with spastic hemiparetic cerebral palsy. The study will also compare the effects of robot-assisted mirror therapy with those of conventional mirror therapy.

The main questions this study aims to answer are:

Read more
  • Does robot-assisted mirror therapy improve spasticity, grip strength, selective motor control, hand skills, bimanual performance, participation in activities of daily living, and quality of life?
  • Does robot-assisted mirror therapy improve upper extremity function more than conventional mirror therapy?

Researchers will compare robot-assisted mirror therapy combined with neurodevelopmental treatment with conventional mirror therapy combined with neurodevelopmental treatment.

Participants will:

  • Receive individualized neurodevelopmental treatment for 6 weeks.
  • Complete a 2-week interval after neurodevelopmental treatment.
  • Be randomly assigned to either the robot-assisted mirror therapy group or the conventional mirror therapy group.
  • Receive robot-assisted mirror therapy or conventional mirror therapy twice a week for 6 weeks.
  • Complete assessments before neurodevelopmental treatment, after neurodevelopmental treatment, before the study intervention, and after the intervention.

Researchers will evaluate upper extremity function, spasticity, grip strength, selective motor control, hand skills, bimanual performance, participation in activities of daily living, and quality of life using standardized clinical assessment tools.

Read the detailed description

EFFECT OF ROBOT-ASSISTED MIRROR THERAPY ON UPPER EXTREMITY FUNCTIONS IN HEMIPARETIC CEREBRAL PALSY REHABILITATION

-1 . INTRODUCTION :

Cerebral palsy (CP) is a group of permanent disorders of movement and posture caused by non-progressive disturbances in the developing brain. It has a worldwide prevalence of 2 to 3 per 1,000 live births and is the most common cause of motor disability in children. Spastic CP accounts for 85 to 91 percent of all cases, and hemiplegia is its most common subtype, accounting for approximately 38 percent of cases.

Hemiplegic cerebral palsy is characterized by unilateral motor and sensory impairments resulting from damage to the motor cortex and corticospinal tract. In nearly half of the cases, the upper limbs-particularly the hands-are more severely affected than the lower limbs. Patients typically present with limited upper extremity range of motion, increased muscle tone, muscle weakness, impaired isolated finger movements, and reduced grip function. Collectively, these symptoms adversely affect the performance of activities of daily living and participation in social life, potentially leading to the learned non-use of the affected limb and further impairment of motor function.

Various rehabilitation techniques have been developed to improve upper extremity function and performance in activities of daily living. Mirror therapy (MT), developed by Ramachandran, is one such approach. MT is based on the mirror neuron system, in which neurons in the premotor cortex and inferior parietal cortex are activated during both the observation and the execution of a movement. This technique involves placing a mirror between the unaffected and affected limbs. The mirror creates a visual illusion in which the movement of the unaffected limb is perceived as that of the affected limb. This illusion activates the mirror neuron system, which plays a key role in both action observation and action execution.

The mirror neuron system (MNS) encompasses a network of brain regions, including the ventral premotor cortex (area F5), supplementary motor area (SMA), inferior frontal gyrus (IFG), and inferior parietal lobule (IPL). This system plays a crucial role in action recognition and motor learning by enabling the observation and internal simulation of motor actions.

Investigators have utilized mirror therapy to address various unilateral neurological and orthopedic conditions, including pain and motor impairments. Most studies have focused on adult patients with post-stroke hemiparesis, demonstrating that MT effectively enhances motor cortex activation, leading to improvements in upper extremity motor function and overall functional performance.

Mirror therapy is a promising, non-invasive, low-cost intervention for children with hemiparetic cerebral palsy. Studies have shown that mirror therapy can modulate cortical activity through visual feedback in children with spastic hemiparetic cerebral palsy. This modulation promotes functional improvement and partially compensates for the lack of age-appropriate sensorimotor stimulation, thereby enhancing upper extremity function. Only a limited number of studies have investigated the use of mirror therapy in children with hemiparetic cerebral palsy, either as a standalone intervention or as an adjunct to other therapeutic approaches. Reported benefits include improvements in grasp and pinch strength, upper extremity function, gross motor skills, bimanual performance, and performance in activities of daily living. However, evidence regarding its effects on participation and quality of life within the framework of the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY), remains inconclusive.

Evidence supporting the use of mirror therapy in children with cerebral palsy remains limited. The need for more methodologically rigorous studies specifically targeting this population has been emphasized. In addition, further research evaluating performance in activities of daily living and hand function has been recommended. Recent evidence suggests that combined therapeutic interventions have the potential to enhance recovery in individuals with moderate to severe upper extremity dysfunction following stroke. In this context, several researchers have combined mirror therapy with wearable robotic devices, an approach known as robot-assisted mirror therapy (RAT). Unlike conventional mirror therapy (MT), which provides only visual feedback, robot-assisted mirror therapy (RAT) generates both visual and somatosensory feedback by inducing passive movement of the affected limb. This process provides proprioceptive input to the sensory cortex, thereby facilitating neuroplasticity and functional recovery of the affected upper extremity. Evidence suggests that integrating mirror therapy with a wearable robotic glove may enhance neural activity in the contralateral motor cortex and promote a more balanced pattern of interhemispheric cortical activation during grasping tasks in participants following stroke. Similarly, preliminary evidence suggests that robot-assisted mirror therapy (RAT) may lead to greater improvements in motor function than conventional mirror therapy (MT). Although RAT has been shown to be a feasible treatment approach, its neurological effects, particularly in pediatric populations, remain unclear, and its efficacy relative to conventional MT has yet to be established. Further studies are needed to determine its effects on functional recovery.

Therefore, the aim of this study is to investigate the effects of robot-assisted mirror therapy on spasticity, grip strength, hand function, selective motor control, bimanual performance, participation in activities of daily living, and quality of life in children with spastic hemiparetic cerebral palsy, and to compare these outcomes with those achieved through conventional mirror therapy.

-2. METHOD :

The study was approved by the Non-Interventional Research Ethics Committee of Istanbul Medipol University (Approval No. E-10840098-202.3.02-8027) on December 21, 2024.

The study will include 20 children aged 6-17 years with hemiparetic cerebral palsy who are receiving rehabilitation at the Dilbade Special Education and Rehabilitation Center and meet the inclusion criteria. Written informed consent will be obtained from the parents or legal guardians of all participants after they have been fully informed about the study. In addition, all children will receive age-appropriate information about the study before participation.

-2.1. Demographic data :

The following demographic and clinical characteristics will be recorded: age, sex, height, weight, body mass index (BMI), affected side, gestational age at birth, mode of delivery, history of neonatal intensive care unit (NICU) admission, orthosis use and duration of use, comorbidities, history of seizures, previous botulinum toxin injections and surgical interventions, duration and frequency of physiotherapy, and Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS) levels.

-2.2. Randomization and Intervention Groups :

After baseline demographic data are collected and the initial assessments (T0) are completed, all participants who meet the inclusion criteria will receive individualized neurodevelopmental treatment for 6 weeks, administered twice weekly, with each session lasting 40 minutes. At the end of this treatment period, the second assessment (T1) will be performed. Following the T1 assessment, a 2-week interval will be observed. At the end of this period, each participant will be assigned a unique identification number and allocated equally to one of the two groups using the Randomizer software, with stratified randomization based on age and MACS level. This method will help ensure balance between the groups in terms of demographic and clinical characteristics. Randomization will be performed by a staff member working at the clinic who is not otherwise involved in the study.

  • Group 1 (RAT) (n = 10): Robot-assisted mirror therapy group
  • Group 2 (MT) (n = 10): Mirror therapy group

Both groups will be assessed before the intervention (T2) and after the intervention (T3).

-2.3. Intervention Methods for Groups :

Following completion of the neurodevelopmental treatment administered up to the T1 assessment, participants in both groups will receive an additional intervention over a 6-week period. The intervention will be administered twice weekly, with each session lasting 30 minutes.

-2.3.1. Robot-assisted mirror therapy group :

The participant will be seated in an ergonomic chair at a table, with the hips and knees flexed to 90 degrees. The unaffected upper limb will be positioned in front of a Metafiz brand mirror placed on the table. After the affected upper limb is positioned behind the mirror, a robotic glove will be fitted to the participant's affected hand. The FosilTech robotic glove (FosilTech, Turkey) used in this study is similar to a robotic glove model previously reported to be suitable and valid for use in pediatric robotic rehabilitation. The participant will perform predetermined exercises by observing the mirror reflection of movements performed by the unaffected limb. Simultaneously, behind the mirror, passive movements symmetrical to those performed by the unaffected limb will be induced in the affected limb using a robotic glove. This approach aims to provide somatosensory stimulation to the affected limb, thereby promoting activation of the affected cerebral hemisphere.

-2.3.2. Mirror therapy group :

While seated in an ergonomic chair at a table, with the hips and knees flexed to 90 degrees, the participant's unaffected upper limb will be positioned in front of a Metafiz-brand mirror (Metafiz, Turkey) placed on the table. After the affected upper limb is positioned behind the mirror, the participant will perform the predetermined exercises with the unaffected hand while observing its reflection in the mirror. No intervention will be applied to the affected limb.

  • 2.3.3. Exercise Protocol for Robot-Assisted Mirror Therapy and Mirror Therapy
  • Exercise duration is planned as 30 minutes.
  • The first 10 minutes of exercises will be for joint movements and grip, and the last 20 minutes will be for activity.
  • Each given exercise will be done for 1 minute :

MCP joint flexion and extension, thumb flexion and extension, pinch grip, tripod pinch, hook grasp, spherical grasp, lateral pinch, wrist flexion and extension with the fingers extended, wrist flexion and extension with the fingers flexed, thumb opposition

-Each given exercise will be done for 2 minutes :

Rolling a cylinder (wrist and finger extension), grasping and releasing a ball (gross grasp and release), grasping and releasing a cup (cylindrical grasp), grasping and releasing objects using tripod tongs (tripod pinch), picking up small objects (pinch grip), cutting toy vegetables with a toy knife (lateral pinch), placing rings (hook grasp), drawing shapes (pencil grasp), gathering a towel (finger flexion) and striking an object (wrist movements combined with finger flexion and extension)

-2.3.4. Exercise Protocol for Neurodevelopmental Treatment :

No additional treatment will be administered beyond each participant's individualized neurodevelopmental treatment (NDT) program.

The exercises included in the neurodevelopmental treatment (NDT) program will be as follows: Lower extremity and balance training will include gastrocnemius and hamstring stretching; strengthening of the evertor, dorsiflexor, quadriceps, and hip muscles; and balance exercises performed with the eyes open and closed. Upper extremity training will include biceps and wrist stretching; strengthening of the triceps, shoulder girdle, scapular, and wrist muscles; forearm supination; wrist and finger flexion and extension; gross grasp and release; and pinch, cylindrical, tripod, lateral, and hook grasp exercises.

-2.4. Assessment Methodology :

The researchers will utilize the following assessment tools to evaluate the participants :

  • 1. Manual Ability Classification System (MACS)
  • 2. Gross Motor Function Classification System (GMFCS)
  • 3. Communication Function Classification System (CFCS)
  • 4. Modified Ashworth Scale (MAS)
  • 5. Selective Control of the Upper Extremity Scale (SCUES)
  • 6. Jebsen-Taylor Hand Function Test (JTHFT)
  • 7. Children's Hand-use Experience Questionnaire (CHEQ)
  • 8. Revised Pediatric Motor Activity Log (R-PMAL)
  • 9. Canadian Occupational Performance Measure (COPM)
  • 10. Pediatric Outcomes Data Collection Instrument (PODCI)

At baseline, children's gross motor function, manual ability, and communication function will be classified using the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS), respectively. These three classification systems will be used to determine eligibility according to the inclusion criteria, while the remaining assessment instruments will be used to evaluate the primary and secondary outcomes.

All primary and secondary outcome measures will be assessed at four time points: at baseline, before the neurodevelopmental treatment (NDT) period (T0); at the end of Week 6, after the NDT period (T1); at the end of Week 8, immediately before the 6-week combined intervention consisting of NDT plus robot-assisted mirror therapy (NDT+RAT) or NDT plus mirror therapy (NDT+MT) (T2); and at the end of Week 14, immediately after the combined intervention (T3).

-2.5. Statistical analysis :

The sample size was determined using G*Power (version 3.1). Based on a similar study, the effect size for the difference between two independent groups was calculated as d = 2.87. The power analysis indicated that a minimum of 8 participants, with at least 4 participants per group, was required with a type I error rate of 5 percent (alpha = 0.05) and a statistical power of 80 percent (1 - beta = 0.80). Although the large effect size (d = 2.87) reported by Kara et al. (2020) was used as a reference, the possibility of effect size overestimation in clinical studies was taken into consideration. Therefore, to increase the statistical power of the study and enhance the generalizability of the findings, the sample size was increased to a total of 20 participants, with 10 participants allocated to each group.

Data will be analyzed using IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp., Armonk, NY, USA). For statistical analysis, the sign test, Mann-Whitney U test, and correlation analyses using Pearson's and Spearman's correlation coefficients will be used. A p-value of less than 0.05 will be considered statistically significant.

Being tested
Robot-Assisted Mirror Therapy, Mirror Therapy, Neurodevelopmental Treatment
Keywords
Hemiplegic Cerebral Palsy, Cerebral Palsy, Mirror Therapy, Robotic-Assisted Mirror Therapy, Rehabilitation, Visual Feedback, Wearable Robotics, Spastic Hemiparesis
Medical subject headings
Cerebral Palsy, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-Assisted Mirror TherapyDevice

    Participants will receive robot-assisted mirror therapy in addition to neurodevelopmental treatment. The unaffected hand will perform movements in front of a mirror, while the affected hand will be positioned behind it inside a pneumatic robotic glove (FosilTech, Turkey). The glove operates through air compression and vacuum. For each movement, the air valves controlling the fingers will be set open or closed. Open valves permit airflow and passive finger movement, whereas closed valves restrict airflow and stop selected fingers. The valve configuration will be adjusted to create a hand position symmetrical to that of the unaffected hand. The motor will be operated via remote control in synchrony and coordination with the unaffected-hand movements, producing corresponding passive movements of the affected hand and providing mirrored visual feedback and bilateral movement training. Robot-assisted mirror therapy will be administered for 30 minutes per session, twice weekly for 6 weeks.

  • Mirror TherapyBehavioural

    Participants will receive conventional mirror therapy in addition to neurodevelopmental treatment. A mirror is positioned in the participant's midsagittal plane to create the visual illusion that the affected upper extremity is moving normally while performing bilateral upper extremity exercises. Mirror therapy will be administered for 30 minutes per session, twice weekly for 6 weeks.

  • Neurodevelopmental TreatmentBehavioural

    Participants will receive a neurodevelopmental treatment (NDT) program administered by a physiotherapist. The intervention will focus on facilitating normal movement patterns, postural control, balance, and upper extremity function through task-oriented therapeutic activities. NDT will be administered for 40 minutes per session, twice weekly for 6 weeks.

Study groups in NCT07763691
Study groupRoleWhat they receive
Robot-Assisted Mirror Therapy (RAT)ExperimentalAll participants will first undergo baseline assessment and receive neurodevelopmental treatment (NDT). After the NDT period, participants will be reassessed and randomized. Participants allocated to this arm will receive robot-assisted mirror therapy in addition to NDT twice weekly for 6 weeks. Each session will include 40 minutes of NDT and 30 minutes of robotic intervention. Participants will perform the planned exercises with the unaffected upper extremity positioned in front of the therapy mirror (Metafiz, Turkey), while the hemiparetic upper extremity will be positioned behind the mirror inside a robotic glove (FosilTech, Turkey). The commercially available robotic glove uses a mechanism similar to that of devices previously shown feasible for pediatric rehabilitation. During the intervention, it will provide passive symmetrical movements to the affected upper extremity corresponding to the exercises performed by the unaffected upper extremity in front of the mirror.
Receives: Device: Robot-Assisted Mirror Therapy; Behavioral: Neurodevelopmental Treatment
Mirror Therapy (MT)Active comparatorAll participants will undergo baseline assessment and receive neurodevelopmental treatment (NDT). After completion of the NDT period, participants will be reassessed and randomized. Participants assigned to this arm will receive a combined intervention consisting of NDT and conventional mirror therapy twice weekly for 6 weeks. Each session will include 40 minutes of NDT followed by 30 minutes of mirror therapy. During mirror therapy, participants will perform the planned exercises with the unaffected upper extremity positioned in front of the therapy mirror (Metafiz, Turkey), while the affected upper extremity will be positioned behind the mirror. No intervention will be applied directly to the affected upper extremity during mirror therapy. Participants will observe the mirror reflection of the unaffected upper-extremity movements, thereby creating the visual illusion that the affected upper extremity is performing the movements.
Receives: Behavioral: Mirror Therapy; Behavioral: Neurodevelopmental Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Self-Perceived Occupational Performance as Measured by the Canadian Occupational Performance Measure (COPM)

    The Canadian Occupational Performance Measure (COPM) is a client-centered measure of occupational performance in self-care, productivity, and leisure. Children identify important activities they want, need, or are expected to perform but find difficult and rate their performance on a 10-point scale; higher scores indicate better performance. The mean performance score is the sum of the ratings divided by the number of activities. Changes in the mean performance score will be calculated for the relevant assessment periods by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive change scores indicate improved self-perceived occupational performance.

    In the present study, the COPM will be used to assess children's occupational performance in daily life activities they identify as important.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  2. Change in Self-Perceived Satisfaction With Occupational Performance as Measured by the Canadian Occupational Performance Measure (COPM)

    The Canadian Occupational Performance Measure (COPM) is a client-centered measure of satisfaction with occupational performance in self-care, productivity, and leisure. Children identify important activities they want, need, or are expected to perform but find difficult and rate their satisfaction with their performance on a 10-point scale; higher scores indicate greater satisfaction. The mean satisfaction score is the sum of the ratings divided by the number of activities. Changes in the mean satisfaction score will be calculated for the relevant assessment periods by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive change scores indicate increased satisfaction with occupational performance.

    In the present study, the COPM will be used to assess children's satisfaction with their performance in daily life activities they identify as important.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

Secondary outcomes (13)
  1. Change in Wrist Flexor Spasticity as Assessed by the Modified Ashworth Scale (MAS)

    The Modified Ashworth Scale (MAS) is widely used to assess spasticity. With the participant relaxed in the supine position and the forearm positioned in pronation, the wrist is moved rapidly and passively from flexion to extension. Resistance encountered during passive movement is graded as 0, 1, 1+, 2, 3, or 4. Grade 0 indicates no increase in muscle tone, whereas Grade 4 indicates rigidity. In this study, the MAS will be used to assess wrist flexor spasticity. Changes in MAS grade will be assessed between baseline and Week 6 and between Week 8 and Week 14. A shift to a lower grade indicates reduced spasticity.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  2. Change in Wrist Extensor Spasticity as Assessed by the Modified Ashworth Scale (MAS)

    The Modified Ashworth Scale (MAS) is widely used to assess spasticity. With the participant relaxed in the supine position and the forearm positioned in pronation, the wrist is moved rapidly and passively from extension to flexion. Resistance encountered during passive movement is graded as 0, 1, 1+, 2, 3, or 4. Grade 0 indicates no increase in muscle tone, whereas Grade 4 indicates rigidity. In this study, the MAS will be used to assess wrist extensor spasticity. Changes in MAS grade will be assessed between baseline and Week 6 and between Week 8 and Week 14. A shift to a lower grade indicates reduced spasticity.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  3. Change in Forearm Pronator Spasticity as Assessed by the Modified Ashworth Scale (MAS)

    The Modified Ashworth Scale (MAS) is widely used to assess spasticity. With the participant relaxed in the supine position, the forearm is moved rapidly and passively from pronation to supination. Resistance encountered during passive movement is graded as 0, 1, 1+, 2, 3, or 4. Grade 0 indicates no increase in muscle tone, whereas Grade 4 indicates rigidity. In this study, the MAS will be used to assess forearm pronator spasticity. Changes in MAS grade will be assessed between baseline and Week 6 and between Week 8 and Week 14. A shift to a lower grade indicates reduced spasticity.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  4. Change in Forearm Supinator Spasticity as Assessed by the Modified Ashworth Scale (MAS)

    The Modified Ashworth Scale (MAS) is widely used to assess spasticity. With the participant relaxed in the supine position, the forearm is moved rapidly and passively from supination to pronation. Resistance encountered during passive movement is graded as 0, 1, 1+, 2, 3, or 4. Grade 0 indicates no increase in muscle tone, whereas Grade 4 indicates rigidity. In this study, the MAS will be used to assess forearm supinator spasticity. Changes in MAS grade will be assessed between baseline and Week 6 and between Week 8 and Week 14. A shift to a lower grade indicates reduced spasticity.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  5. Change in Selective Motor Control of the Affected Upper Extremity as Measured by the Total Selective Control of the Upper Extremity Scale (SCUES) Score

    The Selective Control of the Upper Extremity Scale (SCUES) assesses selective voluntary motor control at five upper extremity joint levels: shoulder, elbow, forearm, wrist, and fingers/thumb. Each joint level is scored from 0 to 3: 0 indicates no selective motor control, 1 moderately diminished, 2 mildly diminished, and 3 normal selective motor control. The five scores are summed to obtain a total score ranging from 0 to 15, with higher scores indicating better selective motor control. In the present study, the SCUES will be used to assess selective motor control of the affected upper extremity. Changes in the total score will be calculated by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive change scores indicate improved selective motor control.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  6. Change in Affected-Hand Function as Measured by Total Completion Time on the Jebsen-Taylor Hand Function Test (JTHFT)

    The Jebsen-Taylor Hand Function Test (JTHFT) assesses hand function using seven timed tasks reflecting activities of daily living: writing a standardized sentence, turning over cards, picking up small objects, simulated feeding, stacking checkers, and moving large light and heavy objects. Each task is timed in seconds, with a maximum of 180 seconds; 180 seconds will be assigned if a task is not completed within this limit. Task times are summed to obtain a total completion time ranging from 0 to 1260 seconds, with lower times indicating better hand function. In the present study, the JTHFT will be used to assess the function of the affected hand. Changes in total completion time will be calculated by subtracting the baseline time from the Week 6 time and the Week 8 time from the Week 14 time. Negative change values indicate improved hand function.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  7. Change in Affected-Hand Grasp Efficacy During Bimanual Daily Activities as Measured by the Children's Hand-use Experience Questionnaire (CHEQ) Grasp Efficacy Score

    The Children's Hand-use Experience Questionnaire (CHEQ) evaluates children's experience of using their affected hand during bimanual activities of daily living. It was developed for children aged 6-18 years with unilateral hand impairment. The Grasp Efficacy scale assesses how effectively the affected hand is used to grasp or support objects during these activities. Responses are provided on a 4-point scale and converted through Rasch analysis to a score ranging from 0 to 100, with higher scores indicating greater grasp efficacy. The Turkish version has been reported to be valid and reliable. In the present study, the CHEQ Grasp Efficacy scale will be used to assess children's perceived performance in activities of daily living. Changes in the score will be calculated by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive change scores indicate improved grasp efficacy.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  8. Change in Time Utilization During Bimanual Daily Activities as Measured by the Children's Hand-use Experience Questionnaire (CHEQ) Time Utilization Score

    The Children's Hand-use Experience Questionnaire (CHEQ) evaluates children's experience of using their affected hand during bimanual activities of daily living. It was developed for children aged 6-18 years with unilateral hand impairment. The Time Utilization scale assesses the child's perceived time required to perform these activities compared with peers. Responses range from requiring considerably more time to requiring an equal amount of time and are converted through Rasch analysis to a score ranging from 0 to 100, with higher scores indicating more efficient time utilization. The Turkish version has been reported to be valid and reliable. In the present study, the CHEQ Time Utilization scale will be used to assess children's perceived performance in activities of daily living. Changes in the score will be calculated by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive change scores indicate improved time utilization.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  9. Change in Perceived Bother During Bimanual Daily Activities as Measured by the Children's Hand-use Experience Questionnaire (CHEQ) Feeling Bothered Score

    The Children's Hand-use Experience Questionnaire (CHEQ) evaluates children's experience of using their affected hand during bimanual activities of daily living. It was developed for children aged 6-18 years with unilateral hand impairment. The Feeling Bothered scale assesses how bothered the child feels by reduced hand or arm function while performing these activities. Responses range from being bothered a lot to not being bothered at all and are converted through Rasch analysis to a score ranging from 0 to 100, with higher scores indicating less perceived bother. The Turkish version has been reported to be valid and reliable. In the present study, the CHEQ Feeling Bothered scale will be used to assess children's perceived performance in activities of daily living. Changes in the score will be calculated by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive change scores indicate reduced perceived bother.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  10. Change in Frequency of Affected Upper-Extremity Use During Daily Activities as Measured by the Mean How Often Score on the Revised Pediatric Motor Activity Log (PMAL-R)

    The Revised Pediatric Motor Activity Log (PMAL-R) is a structured parent interview assessing the real-world use of the affected upper extremity. The How Often scale evaluates how frequently the affected upper extremity is used during 22 daily activities. Items are rated from 0 (not used) to 5 (used as often as the less-affected upper extremity). The mean item score ranges from 0 to 5, with higher scores indicating more frequent use. In the present study, the PMAL-R will be used to assess the use of the affected upper extremity in daily activities and unimanual performance. Changes will be calculated by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive values indicate more frequent use.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  11. Change in Quality of Affected Upper-Extremity Use During Daily Activities as Measured by the Mean How Well Score on the Revised Pediatric Motor Activity Log (PMAL-R)

    The Revised Pediatric Motor Activity Log (PMAL-R) is a structured parent interview assessing the real-world use of the affected upper extremity. The How Well scale evaluates the quality of affected upper-extremity use during 22 daily activities. Items are rated from 0 (not used) to 5 (normal performance). The mean item score ranges from 0 to 5, with higher scores indicating better quality of use. In the present study, the PMAL-R will be used to assess the use of the affected upper extremity in daily activities and unimanual performance. Changes will be calculated by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive values indicate improved quality of use.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  12. Change in Parent-Reported Functional Health and Health-Related Quality of Life as Measured by the Pediatric Outcomes Data Collection Instrument (PODCI) Global Functioning Score

    The Pediatric Outcomes Data Collection Instrument (PODCI) evaluates functional health and health-related quality of life. The parent-report form is completed by the child's caregiver. The Global Functioning Score combines Upper Extremity and Physical Function, Transfers and Basic Mobility, Sports and Physical Function, and Pain/Comfort. Scores range from 0 to 100, with higher scores indicating better functioning. In the present study, the PODCI will be used to assess functional health and health-related quality of life. Changes will be calculated by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive values indicate improvement in parent-reported global functioning.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

  13. Change in Child Self-Reported Functional Health and Health-Related Quality of Life as Measured by the Pediatric Outcomes Data Collection Instrument (PODCI) Global Functioning Score

    The Pediatric Outcomes Data Collection Instrument (PODCI) evaluates functional health and health-related quality of life. The child self-report form is completed by the child. The Global Functioning Score combines Upper Extremity and Physical Function, Transfers and Basic Mobility, Sports and Physical Function, and Pain/Comfort. Scores range from 0 to 100, with higher scores indicating better functioning. In the present study, the PODCI will be used to assess functional health and health-related quality of life. Changes will be calculated by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive values indicate improvement in child-reported global functioning.

    Measured: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2026
  2. Study start25 Mar 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
All participants initially receive neurodevelopmental treatment and are evaluated before and after this initial treatment period. Following this period, participants are randomized into two parallel groups. One group receives robot-assisted therapy in addition to neurodevelopmental treatment, while the other group receives mirror therapy in addition to neurodevelopmental treatment. This design allows the effects of the initial neurodevelopmental treatment period to be evaluated, as well as the effects of the two subsequent treatment approaches to be compared.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07763691
Sponsor's protocol ID
E-10840098-202.3.02-8027 /1298
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data collected during the study, including demographic data, baseline characteristics, intervention-related data, outcome measures, and follow-up assessments, will be made available after completion of the primary study analyses and publication of the main study results in an international peer-reviewed journal. A data dictionary and relevant study documentation necessary for data interpretation will also be provided.

Publications

  • Jackman M, Sakzewski L, Morgan C, Boyd RN, Brennan SE, Langdon K, Toovey RAM, Greaves S, Thorley M, Novak I. Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. Dev Med Child Neurol. 2022 May;64(5):536-549. doi: 10.1111/dmcn.15055. Epub 2021 Sep 21.

    PubMed 34549424
  • Goyal C, Vardhan V, Naqvi W. Virtual Reality-Based Intervention for Enhancing Upper Extremity Function in Children With Hemiplegic Cerebral Palsy: A Literature Review. Cureus. 2022 Jan 28;14(1):e21693. doi: 10.7759/cureus.21693. eCollection 2022 Jan.

    PubMed 35237486
  • Kara OK, Yardimci BN, Sahin S, Orhan C, Livanelioglu A, Soylu AR. Combined Effects of Mirror Therapy and Exercises on the Upper Extremities in Children with Unilateral Cerebral Palsy: A Randomized Controlled Trial. Dev Neurorehabil. 2020 May;23(4):253-264. doi: 10.1080/17518423.2019.1662853. Epub 2019 Sep 13.

    PubMed 31514564
  • Najiha A, Alagesan J. Mirror therapy : A review of evidences. International Journal of Physiotherapy and Research. 2015, 3(3):1086-90.

  • Stevens JA, Stoykov ME. Using motor imagery in the rehabilitation of hemiparesis. Arch Phys Med Rehabil. 2003 Jul;84(7):1090-2. doi: 10.1016/s0003-9993(03)00042-x.

    PubMed 12881842
  • Kim DH, Lee KD, Bulea TC, Park HS. Increasing motor cortex activation during grasping via novel robotic mirror hand therapy: a pilot fNIRS study. J Neuroeng Rehabil. 2022 Jan 24;19(1):8. doi: 10.1186/s12984-022-00988-7.

    PubMed 35073933
  • Bruchez R, Jequier Gygax M, Roches S, Fluss J, Jacquier D, Ballabeni P, Grunt S, Newman CJ. Mirror therapy in children with hemiparesis: a randomized observer-blinded trial. Dev Med Child Neurol. 2016 Sep;58(9):970-8. doi: 10.1111/dmcn.13117. Epub 2016 Apr 5.

    PubMed 27046296
  • Gygax MJ, Schneider P, Newman CJ. Mirror therapy in children with hemiplegia: a pilot study. Dev Med Child Neurol. 2011 May;53(5):473-6. doi: 10.1111/j.1469-8749.2011.03924.x. Epub 2011 Mar 17.

    PubMed 21410693
  • Palomo-Carrion R, Zuil-Escobar JC, Cabrera-Guerra M, Barreda-Martinez P, Martinez-Cepa CB. [Mirror and action observation therapy in children with unilateral spastic cerebral palsy: a feasibility study]. Rev Neurol. 2022 Dec 1;75(11):325-332. doi: 10.33588/rn.7511.2022343. Spanish.

    PubMed 36440744
  • Farzamfar, P.; Heirani, A.; Sedighi, M. The effect of motor training in mirror therapy on gross motor skills of the affected hand in children with hemiplegia. Iran. Rehabil. J. 2017, 15, 243-248.

  • Ortega-Martinez A, Palomo-Carrion R, Varela-Ferro C, Bagur-Calafat MC. Feasibility of a Home-Based Mirror Therapy Program in Children with Unilateral Spastic Cerebral Palsy. Healthcare (Basel). 2023 Jun 19;11(12):1797. doi: 10.3390/healthcare11121797.

    PubMed 37372915
  • Park EJ, Baek SH, Park S. Systematic review of the effects of mirror therapy in children with cerebral palsy. J Phys Ther Sci. 2016 Nov;28(11):3227-3231. doi: 10.1589/jpts.28.3227. Epub 2016 Nov 29.

    PubMed 27942154
  • Nam HS, Koh S, Beom J, Kim YJ, Park JW, Koh ES, Chung SG, Kim S. Recovery of Proprioception in the Upper Extremity by Robotic Mirror Therapy: a Clinical Pilot Study for Proof of Concept. J Korean Med Sci. 2017 Oct;32(10):1568-1575. doi: 10.3346/jkms.2017.32.10.1568.

    PubMed 28875598
  • Schrader M, Sterr A, Kettlitz R, Wohlmeiner A, Buschfort R, Dohle C, Bamborschke S. The effect of mirror therapy can be improved by simultaneous robotic assistance. Restor Neurol Neurosci. 2022;40(3):185-194. doi: 10.3233/RNN-221263.

    PubMed 35848045
  • Lieber J, Dittli J, Lambercy O, Gassert R, Meyer-Heim A, van Hedel HJA. Clinical utility of a pediatric hand exoskeleton: identifying users, practicability, and acceptance, and recommendations for design improvement. J Neuroeng Rehabil. 2022 Feb 11;19(1):17. doi: 10.1186/s12984-022-00994-9.

    PubMed 35148786

Questions about this trial

What is this clinical trial studying?

A study testing Robot-Assisted Mirror Therapy, Mirror Therapy and Neurodevelopmental Treatment in people with Cerebral Palsy (CP) and Hemiparetic Cerebral Palsy, run by Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Self-Perceived Occupational Performance as Measured by the Canadian Occupational Performance Measure (COPM) (time frame: Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07763691, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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