Spastic Hemiplegic Cerebral PalsyNCT06352762
The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy
A study testing Conventional physiotherapy and Robotic Rehabilitation in people with Spastic Hemiplegic Cerebral Palsy and Upper Extremity Paresis, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP). Methods: 34 hCP patients attended the study. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy, Upper Extremity Paresis, Robotic Rehabilitation
- What is being tested?
- Conventional physiotherapy and Robotic Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2017to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with spastic hemiparetic CP
- Upper extremity muscle tone between 1-3 according to the Modified Ashworth Scale
- According to Gross Motor Functional Clasification System level 1-2-3
- Able to understand simple instructions
Who cannot join
- Having a history of epilepsy
- Having botox in the last 6 months
- Having surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Upper Extremity Robotic Rehabilitation on Upper Extremity Skills and Functional Independence Level in Patients With Spastic Hemiparetic Cerebral Palsy
Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP).
Methods: 34 hCP patients attended the study. 17 children in the training group recived conventional physiotherapy and Robotic Rehabilitation. 17 children in the control group recived only conventional physiotherapy. Convantional physiotherapy program lasted 45 minutes, Robotic Rehabilitation program lasted 30 minutes. All participants were enrolled in sessions 3 times a week for 5 weeks. Measurements were made before and after the therapy. Outcome measures were Modified Ashworth Scale (MAS) for muscle tone, Abilhand-Kids Test for manual skills, The Quality of Upper Extremity Skills Test (QUEST) for upper extremity motor function and The WeeFIM for functional independence level.
Read the detailed description
Cerebral Palsy (CP) is a permanent but non-progressive neurodevelopmental disorder that occurs in the immature brain and causes activity limitations in children. Epilepsy, cognitive disorders, behavioral disorders, visual-hearing losses and sensory disorders may be observed in children with CP along with motor damage. Motor dysfunction disorders constitute one of the most basic problems in patients with CP. Hand-arm coordination disorders, grip disorders and sensory disorders in the upper extremities negatively affect the daily life activities and functional independence levels of patients. It has been shown that neglect occurs with advancing age in cases with CP when upper limb treatment is delayed, and compensation mechanisms develop involving the use of unaffected side upper limbs to ensure daily living activities. Upper limb functional skills are very important to be able to perform daily life activities. It is not possible to perform activities such as holding and releasing objects, reaching for objects with non-functional upper limbs. Abnormal posture and deformities caused by spasticity restrict the functions of the upper extremities, make daily living activities difficult and increase the burden of people caring for the child. With the technological developments in recent years, virtual reality applications and robotic rehabilitation programs play an important role in CP rehabilitation. Significant improvements have been shown, especially in the development of walking, balance and postural control. Intensive practical, frequent repetitive movements and functional activities can be provided simultaneously in the same session with robotic rehabilitation applications. In the literature, the effects of robotic rehabilitation applications have been investigated in adult neurological patients. In pediatric patients, studies generally focus on lower limb function and walking. The number of studies examining the effect of robotic rehabilitation on upper limb functions in children with CP are limited. Based on these deficiencies in the literature, the purpose of the planned study was to examine the effect of upper limb robotic rehabilitation on upper limb functions and functional independence level in children diagnosed with spastic hemiparetic CP.
- Being tested
- Conventional physiotherapy, Robotic Rehabilitation
- Keywords
- Spastisity, Motor Function, Cerebral Palsy, Upper Extremity
- Medical subject headings
- Paresis, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyOther
Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions.
Robotic RehabilitationOther
Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions. An additional 30 minutes of robotic rehabilitation was applied to the conventional physiotherapy program. Robotic rehabilitation was applied after each session of conventional physiotherapy applications.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physiotherapy | Active comparator | Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Receives: Other: Conventional physiotherapy |
| Robotic Rehabilitation | Experimental | Strengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. In addition, upper extremity robotic rehabilitation was applied. Receives: Other: Robotic Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Tone
Muscle tone was assessed using the Modified Ashworth Scale. Resistance to passive movement was scored from 0 to 5. Higher scores indicate higher muscle tone. Shoulder extensors, adductors and internal rotators; elbow flexors; forearm pronators, wrist and finger flexors were evaluated. Each region was evaluated individually, and the sum of the measured regions was calculated to determine overall muscle tone.
Measured: Assessment was performed twice, before treatment started and at the end of the fifth week.
Upper Extremity Motor Function
The Quality of Upper Extremity Skills Test (QUEST) was used. The test evaluates dexterity and quality of movement. It consists of a total of 7 headings (Independent movements, grasping, weight bearing, protective extension, degree of hand function, degree of spasticity, level of cooperation) and 34 items. Each item is scored between 0-2. A score of 0 indicates that the movement was not achieved, 1 point indicates that it was partially achieved, and 2 points indicates that it was completely achieved. High scores from the test indicate good upper extremity motor functions.
Measured: Assessment was performed twice, before treatment started and at the end of the fifth week.
Manual Ability
Abilhand-Kids test was used. This test evaluates children's abilities in daily living activities for the hand and upper extremity. The test consists of 21 items. Each item is scored between 0-2. A score of 0 means that the activity cannot be done, a score of 1 means that the child has difficulty in doing the activity, and a score of 2 means that the activity can be done easily. High scores from the test indicate good manual abilities.
Measured: Assessment was performed twice, before treatment started and at the end of the fifth week.
Functional Independence
It was assessed using the pediatric functional independence scale (WeeFIM). It contains a total of 6 topics and 18 questions, including self-control, sphincter control, transfers, locomotion, communication, social and cognitive functions. Each item is scored between 1-7. High scores from the test indicate a high level of independence.
Measured: Assessment was performed twice, before treatment started and at the end of the fifth week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start15 Feb 2017
- Primary completion15 Aug 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- The study was conducted as a randomized controlled study.The first of the cases that met the study criteria was included in the study group, and the second in the control group. Randomization continued in this way.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuriye BUYUKTAS, Izmir Bakircay University
- Investigators
- Nuriye Büyüktaş, MsC, Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352762
- Sponsor's protocol ID
- Izmir Dokuz Eylul University
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Upper Extremity Robotic Rehabilitation on Upper Extremity Skills and Functional Independence Level in Patients With Spastic Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06352762
- Acronym / sponsor ID
- Izmir Dokuz Eylul University
- Keywords
- Spastisity, Motor Function, Cerebral Palsy, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP).
Methods: 34 hCP patients attended the study. 17 children in the training group recived conventional physiotherapy and Robotic Rehabilitation. 17 children in the control group recived only conventional physiotherapy. Convantional physiotherapy program lasted 45 minutes, Robotic Rehabilitation program lasted 30 minutes. All participants were enrolled in sessions 3 times a week for 5 weeks. Measurements were made before and after the therapy. Outcome measures were Modified Ashworth Scale (MAS) for muscle tone, Abilhand-Kids Test for manual skills, The Quality of Upper Extremity Skills Test (QUEST) for upper extremity motor function and The WeeFIM for functional independence level.
Detailed description
Cerebral Palsy (CP) is a permanent but non-progressive neurodevelopmental disorder that occurs in the immature brain and causes activity limitations in children. Epilepsy, cognitive disorders, behavioral disorders, visual-hearing losses and sensory disorders may be observed in children with CP along with motor damage. Motor dysfunction disorders constitute one of the most basic problems in patients with CP. Hand-arm coordination disorders, grip disorders and sensory disorders in the upper extremities negatively affect the daily life activities and functional independence levels of patients. It has been shown that neglect occurs with advancing age in cases with CP when upper limb treatment is delayed, and compensation mechanisms develop involving the use of unaffected side upper limbs to ensure daily living activities. Upper limb functional skills are very important to be able to perform daily life activities. It is not possible to perform activities such as holding and releasing objects, reaching for objects with non-functional upper limbs. Abnormal posture and deformities caused by spasticity restrict the functions of the upper extremities, make daily living activities difficult and increase the burden of people caring for the child. With the technological developments in recent years, virtual reality applications and robotic rehabilitation programs play an important role in CP rehabilitation. Significant improvements have been shown, especially in the development of walking, balance and postural control. Intensive practical, frequent repetitive movements and functional activities can be provided simultaneously in the same session with robotic rehabilitation applications. In the literature, the effects of robotic rehabilitation applications have been investigated in adult neurological patients. In pediatric patients, studies generally focus on lower limb function and walking. The number of studies examining the effect of robotic rehabilitation on upper limb functions in children with CP are limited. Based on these deficiencies in the literature, the purpose of the planned study was to examine the effect of upper limb robotic rehabilitation on upper limb functions and functional independence level in children diagnosed with spastic hemiparetic CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was conducted as a randomized controlled study.The first of the cases that met the study criteria was included in the study group, and the second in the control group. Randomization continued in this way.
| Arm | Type | Receives |
|---|---|---|
| Conventional physiotherapy | Active comparator | Other: Conventional physiotherapyStrengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. |
| Robotic Rehabilitation | Experimental | Other: Robotic RehabilitationStrengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. In addition, upper extremity robotic rehabilitation was applied. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with spastic hemiparetic CP
- Upper extremity muscle tone between 1-3 according to the Modified Ashworth Scale
- According to Gross Motor Functional Clasification System level 1-2-3
- Able to understand simple instructions
Key exclusion criteria (3 listed)
- Having a history of epilepsy
- Having botox in the last 6 months
- Having surgery in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physiotherapyStrengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions. | Other | Conventional physiotherapy |
| Robotic RehabilitationStrengthening and stretching exercises for lower and upper extremity muscles, hip and trunk stabilization training, balance training, gait training, upper extremity functional skills training, endurance training and coordination training were given. Exercises were planned according to the developmental stage. Sessions were applied 3 days a week and 45 minutes for 5 weeks, for a total of 15 sessions. An additional 30 minutes of robotic rehabilitation was applied to the conventional physiotherapy program. Robotic rehabilitation was applied after each session of conventional physiotherapy applications. | Other | Robotic Rehabilitation |
Primary outcome
Muscle Tone
Time frame: Assessment was performed twice, before treatment started and at the end of the fifth week.
Muscle tone was assessed using the Modified Ashworth Scale. Resistance to passive movement was scored from 0 to 5. Higher scores indicate higher muscle tone. Shoulder extensors, adductors and internal rotators; elbow flexors; forearm pronators, wrist and finger flexors were evaluated. Each region was evaluated individually, and the sum of the measured regions was calculated to determine overall muscle tone.
Upper Extremity Motor Function
Time frame: Assessment was performed twice, before treatment started and at the end of the fifth week.
The Quality of Upper Extremity Skills Test (QUEST) was used. The test evaluates dexterity and quality of movement. It consists of a total of 7 headings (Independent movements, grasping, weight bearing, protective extension, degree of hand function, degree of spasticity, level of cooperation) and 34 items. Each item is scored between 0-2. A score of 0 indicates that the movement was not achieved, 1 point indicates that it was partially achieved, and 2 points indicates that it was completely achieved. High scores from the test indicate good upper extremity motor functions.
Manual Ability
Time frame: Assessment was performed twice, before treatment started and at the end of the fifth week.
Abilhand-Kids test was used. This test evaluates children's abilities in daily living activities for the hand and upper extremity. The test consists of 21 items. Each item is scored between 0-2. A score of 0 means that the activity cannot be done, a score of 1 means that the child has difficulty in doing the activity, and a score of 2 means that the activity can be done easily. High scores from the test indicate good manual abilities.
Functional Independence
Time frame: Assessment was performed twice, before treatment started and at the end of the fifth week.
It was assessed using the pediatric functional independence scale (WeeFIM). It contains a total of 6 topics and 18 questions, including self-control, sphincter control, transfers, locomotion, communication, social and cognitive functions. Each item is scored between 1-7. High scores from the test indicate a high level of independence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuriye Büyüktaş, MsC principal investigator
Izmir Bakircay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physiotherapy and Robotic Rehabilitation in people with Spastic Hemiplegic Cerebral Palsy and Upper Extremity Paresis, run by Izmir Bakircay 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle Tone (time frame: Assessment was performed twice, before treatment started and at the end of the fifth week.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2024.