Cerebral PalsyNCT04940143
Effects of Botulinum Toxin Injection on Sensation and Postural Control in Children With Hemiplegic Cerebral Palsy
A study testing Botulinum toxin type-A (Onabotulinum toxin type-A) and Physical Therapy in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to investigate the effects of botulinum neurotoxin type A (BoNT-A) injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic cerebral palsy who are ambulatory without an assistive… Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- What is being tested?
- Botulinum toxin type-A (Onabotulinum toxin type-A) and Physical Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to Sep 2021
- 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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients diagnosed with hemiplegic cerebral palsy
- Age between 5-13 years
- MAS ≥ 2 spasticity in the affected ankle
- Gross Motor Function Classification System (GMFCS) level I-II
- Able to understand given commands
- Sufficient cooperation to understand instructions and participate evaluations
- Giving an informed consent
- Botulinum toxin A injection decision made by an experienced Physiatrist
Who cannot join
- Visual, vestibular and cognitive deficits
- Botulinum toxin A treatment within 6 months or having undergone an orthopaedic surgery 1 year prior to inclusion in the study
- Presence of fixed contracture or joint instability in the affected ankle
- Severe scoliosis (Cobb angle >40°)
- Uncontrolled epilepsy
- Having undergone selective dorsal rhizotomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul
Sefa Kurt, MD, +905385159528, sefa.kurt@yahoo.com
Evrim Karadag Saygi, Prof
About this study
Official title: The Evaluation of Effects of Botulinum Toxin Injection on Lower Extremity Somatosensory Impairment and Postural Control in Children With Hemiplegic Cerebral Palsy
In this study, the investigators aimed to investigate the effects of botulinum neurotoxin type A (BoNT-A) injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic cerebral palsy who are ambulatory without an assistive device in daily life.
Read the detailed description
Cerebral palsy (CP) refers to a group of movement and posture disorders that limit activity and participation, that are attributed to non-progressive disturbances in the developing fetus or infant brain. One of the main clinical findings of CP is postural control disorder. Many concomitant impairments such as joint range of motion limitations, spasticity, contractures, sensory deficits and loss of selective motor control contribute to postural control disorder.
One of the most common causes of motor dysfunction in children with CP is the presence of spasticity. Spasticity in the ankle plantar flexor muscles and weakness in the dorsiflexor muscles are the main factors that cause gait disturbance. Thus, impairments in gait function cause limitation of postural stability. Although there are many methods in spasticity management, BoNT-A injections have been used effectively and safely for many years, especially in reducing ankle plantar flexor spasticity. There are limited number of studies in the literature investigating the effect of BoNT-A injection on postural control in children with spastic CP, and only one study included children with spastic hemiplegic (unilateral) CP and it was clearly highlighted that new studies are needed in this area.
The reclassification of CP acknowledges the contribution of impaired sensation in motor performance. Although it has been shown that somatosensory deficits in the lower extremities of children with spastic CP can negatively affect gait and balance, the effect of spasticity in the ankle has not been evaluated.
In this study, the investigators aimed to investigate the effects of BoNT injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic CP who are ambulatory without an assistive device in daily life.
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Being tested
- Botulinum toxin type-A (Onabotulinum toxin type-A), Physical Therapy
- Keywords
- Botulinum toxin, Hemiplegic cerebral palsy, Postural control, Sensory function, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type-A (Onabotulinum toxin type-A)Drug
Botulinum toxin-A (Onabotulinum toxin type-A/Botox®) injection will be administered from three different points, two on the medial head of the gastrocnemius muscle and one point on the lateral head with total 3-6 units/kg dose, under the guidance of electrical stimulation for the detection of the target neuromuscular junction.
Physical TherapyOther
After the botulinum toxin-A injection, the patients will be included in the comprehensive physiotherapy program thrice a week for a total of 12 weeks. The physiotherapy program will be consisted of the ankle range of motion and stretching, strengthening of the antagonist muscles, proprioception exercises, functional walking training and static and dynamic balance training.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin-A | Experimental | Botulinum toxin-A (Onabotulinum toxin type-A) injection with electrical stimulation guidance will be administered to spastic ankle plantar flexor muscles. After the injection, the patients will be included in the comprehensive physiotherapy program. Receives: Drug: Botulinum toxin type-A (Onabotulinum toxin type-A); Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) of NeuroCom Balance Master
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.
Measured: before intervention (T0)
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.
Measured: 4th week after intervention (T1)
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.
Measured: 3rd month after intervention (T2)
Light touch pressure treshold
Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.
Measured: before intervention (T0)
Light touch pressure treshold
Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.
Measured: 4th week after intervention (T1)
Light touch pressure treshold
Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.
Measured: 3rd month after intervention (T2)
Secondary outcomes (21)
Modified Ashworth Scale (MAS)
Muscle tone and spasticity will be measured with MAS. Muscle tone is scored between 0-4. Higher scores mean more severe spasticity.
Measured: before intervention (T0)
Modified Ashworth Scale (MAS)
Muscle tone and spasticity will be measured with MAS. Muscle tone is scored between 0-4. Higher scores mean more severe spasticity.
Measured: 4th week after intervention (T1)
Modified Ashworth Scale (MAS)
Muscle tone and spasticity will be measured with MAS. Muscle tone is scored between 0-4. Higher scores mean more severe spasticity.
Measured: 3rd month after intervention (T2)
Modified Tardieu Scale (MTS)
Within the Modified Tardieu Scale (MTS), angle of arrest of the ankle joint at slow speed (XV1), angle of catch at fast speed (XV3), spasticity grade (Y), and spasticity angle (X) will be recorded. Angles of arrest and catch will be measured by a goniometer and angle of arrest of the ankle joint at slow speed was recorded as passive range of motion. Higher X angle points out dynamic component of spasticity. Higher Y scores mean more severe spasticity.
Measured: before intervention (T0)
Modified Tardieu Scale (MTS)
Within the Modified Tardieu Scale (MTS), angle of arrest of the ankle joint at slow speed (XV1), angle of catch at fast speed (XV3), spasticity grade (Y), and spasticity angle (X) will be recorded. Angles of arrest and catch will be measured by a goniometer and angle of arrest of the ankle joint at slow speed was recorded as passive range of motion. Higher X angle points out dynamic component of spasticity. Higher Y scores mean more severe spasticity.
Measured: 4th week after intervention (T1)
Modified Tardieu Scale (MTS)
Within the Modified Tardieu Scale (MTS), angle of arrest of the ankle joint at slow speed (XV1), angle of catch at fast speed (XV3), spasticity grade (Y), and spasticity angle (X) will be recorded. Angles of arrest and catch will be measured by a goniometer and angle of arrest of the ankle joint at slow speed was recorded as passive range of motion. Higher X angle points out dynamic component of spasticity. Higher Y scores mean more severe spasticity.
Measured: 3rd month after intervention (T2)
Sit to Stand (STS) test of Neurocom Balance Master
The Sit to stand (STS) test will be done by Balance Master device. Weight transfer time (sec), rising index (%) and sway velocity (deg/sec) will be recorded. The STS is a performance test quantifying the patient's ability, on command, to quickly rise from a seated to a standing position. The STS quantifies time required to transfer weight from the buttock to the feet (weight transfer time (sec)), the strength of the rise (rising index (%)), and the center of gravity sway velocity (deg/sec) during the rise to stand and the first five seconds during standing. Higher scores mean worse dynamic postural control.
Measured: before intervention (T0)
Sit to Stand (STS) test of Neurocom Balance Master
The Sit to stand (STS) test will be done by Balance Master device. Weight transfer time (sec), rising index (%) and sway velocity (deg/sec) will be recorded. The STS is a performance test quantifying the patient's ability, on command, to quickly rise from a seated to a standing position. The STS quantifies time required to transfer weight from the buttock to the feet (weight transfer time (sec)), the strength of the rise (rising index (%)), and the center of gravity sway velocity (deg/sec) during the rise to stand and the first five seconds during standing. Higher scores mean worse dynamic postural control.
Measured: 4th week after intervention (T1)
Sit to Stand (STS) test of Neurocom Balance Master
The Sit to stand (STS) test will be done by Balance Master device. Weight transfer time (sec), rising index (%) and sway velocity (deg/sec) will be recorded. The STS is a performance test quantifying the patient's ability, on command, to quickly rise from a seated to a standing position. The STS quantifies time required to transfer weight from the buttock to the feet (weight transfer time (sec)), the strength of the rise (rising index (%)), and the center of gravity sway velocity (deg/sec) during the rise to stand and the first five seconds during standing. Higher scores mean worse dynamic postural control.
Measured: 3rd month after intervention (T2)
Step&Quick Turn (SQT) test of Neurocom Balance Master
The Step\&Quick Turn (SQT) test will be done by Balance Master device. The SQT is a performance test that quantifies turn performance characteristics. The patient is instructed to take two forward steps on command, and then quickly turn 180˚ to either the left or right and return to the starting point. The time required to execute the turn (sec), and the velocity of COG sway (deg) during the turn will be recorded. Higher scores mean worse dynamic postural control.
Measured: before intervention (T0)
Step&Quick Turn (SQT) test of Neurocom Balance Master
The Step\&Quick Turn (SQT) test will be done by Balance Master device. The SQT is a performance test that quantifies turn performance characteristics. The patient is instructed to take two forward steps on command, and then quickly turn 180˚ to either the left or right and return to the starting point. The time required to execute the turn (sec), and the velocity of COG sway (deg) during the turn will be recorded. Higher scores mean worse dynamic postural control.
Measured: 4th week after intervention (T1)
Step&Quick Turn (SQT) test of Neurocom Balance Master
The Step\&Quick Turn (SQT) test will be done by Balance Master device. The SQT is a performance test that quantifies turn performance characteristics. The patient is instructed to take two forward steps on command, and then quickly turn 180˚ to either the left or right and return to the starting point. The time required to execute the turn (sec), and the velocity of COG sway (deg) during the turn will be recorded. Higher scores mean worse dynamic postural control.
Measured: 3rd month after intervention (T2)
Two-point discrimination
Two-point discrimination will be assessed by using a discriminator (Baseline®, White Plains, New York, NY, USA) on the forefoot and heel of the plantar side of each foot, and scored as the minimum distance in mm between two stimulus points, which were correctly identified as distinct points twice out of three trials for each site. Higher scores mean worse two-point discrimination.
Measured: before intervention (T0)
Two-point discrimination
Two-point discrimination will be assessed by using a discriminator (Baseline®, White Plains, New York, NY, USA) on the forefoot and heel of the plantar side of each foot, and scored as the minimum distance in mm between two stimulus points, which were correctly identified as distinct points twice out of three trials for each site. Higher scores mean worse two-point discrimination.
Measured: 4th week after intervention (T1)
Two-point discrimination
Two-point discrimination will be assessed by using a discriminator (Baseline®, White Plains, New York, NY, USA) on the forefoot and heel of the plantar side of each foot, and scored as the minimum distance in mm between two stimulus points, which were correctly identified as distinct points twice out of three trials for each site. Higher scores mean worse two-point discrimination.
Measured: 3rd month after intervention (T2)
Selective Control Assessment of the Lower Extremity (SCALE)
The lower extremity selective voluntary motor control will be assessed with SCALE tool. Hip, knee, ankle, subtalar, and toe joints are assessed bilaterally in SCALE. Selective voluntary motor control is graded at each joint as 'normal' (2 points), 'impaired' (1 point), or 'unable' (0 points). The SCALE score is the sum of each joint scores and assumes a 10 point maximum per limb. The total SCALE score is between 0-20 and higher scores mean better selective motor control.
Measured: before intervention (T0)
Selective Control Assessment of the Lower Extremity (SCALE)
The lower extremity selective voluntary motor control will be assessed with SCALE tool. Hip, knee, ankle, subtalar, and toe joints are assessed bilaterally in SCALE. Selective voluntary motor control is graded at each joint as 'normal' (2 points), 'impaired' (1 point), or 'unable' (0 points). The SCALE score is the sum of each joint scores and assumes a 10 point maximum per limb. The total SCALE score is between 0-20 and higher scores mean better selective motor control.
Measured: 4th week after intervention (T1)
Selective Control Assessment of the Lower Extremity (SCALE)
The lower extremity selective voluntary motor control will be assessed with SCALE tool. Hip, knee, ankle, subtalar, and toe joints are assessed bilaterally in SCALE. Selective voluntary motor control is graded at each joint as 'normal' (2 points), 'impaired' (1 point), or 'unable' (0 points). The SCALE score is the sum of each joint scores and assumes a 10 point maximum per limb. The total SCALE score is between 0-20 and higher scores mean better selective motor control.
Measured: 3rd month after intervention (T2)
Timed Up and Go (TUG) test
Functional mobility and balance will be assessed the TUG test. It records the time a child needs to stand up from a chair with foot contact, to walk three meter to a target, turn around and return to the chair and sit down as quickly and safely as possible. The test will be repeated three times and the average time (sec) will be recorded. Higher scores mean worse functional mobility.
Measured: before intervention (T0)
Timed Up and Go (TUG) test
Functional mobility and balance will be assessed the TUG test. It records the time a child needs to stand up from a chair with foot contact, to walk three meter to a target, turn around and return to the chair and sit down as quickly and safely as possible. The test will be repeated three times and the average time (sec) will be recorded. Higher scores mean worse functional mobility.
Measured: 4th week after intervention (T1)
Timed Up and Go (TUG) test
Functional mobility and balance will be assessed the TUG test. It records the time a child needs to stand up from a chair with foot contact, to walk three meter to a target, turn around and return to the chair and sit down as quickly and safely as possible. The test will be repeated three times and the average time (sec) will be recorded. Higher scores mean worse functional mobility.
Measured: 3rd month after intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Aug 2020
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Karadag Saygi, Prof, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940143
- Sponsor's protocol ID
- 09.2020.863
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 2 Jul 2021
- 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 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Effects of Botulinum Toxin Injection on Lower Extremity Somatosensory Impairment and Postural Control in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04940143
- Acronym / sponsor ID
- 09.2020.863
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Keywords
- Botulinum toxin, Hemiplegic cerebral palsy, Postural control, Sensory function, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 25 Jun 2021 (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.
In this study, the investigators aimed to investigate the effects of botulinum neurotoxin type A (BoNT-A) injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic cerebral palsy who are ambulatory without an assistive device in daily life.
Detailed description
Cerebral palsy (CP) refers to a group of movement and posture disorders that limit activity and participation, that are attributed to non-progressive disturbances in the developing fetus or infant brain. One of the main clinical findings of CP is postural control disorder. Many concomitant impairments such as joint range of motion limitations, spasticity, contractures, sensory deficits and loss of selective motor control contribute to postural control disorder.
One of the most common causes of motor dysfunction in children with CP is the presence of spasticity. Spasticity in the ankle plantar flexor muscles and weakness in the dorsiflexor muscles are the main factors that cause gait disturbance. Thus, impairments in gait function cause limitation of postural stability. Although there are many methods in spasticity management, BoNT-A injections have been used effectively and safely for many years, especially in reducing ankle plantar flexor spasticity. There are limited number of studies in the literature investigating the effect of BoNT-A injection on postural control in children with spastic CP, and only one study included children with spastic hemiplegic (unilateral) CP and it was clearly highlighted that new studies are needed in this area.
The reclassification of CP acknowledges the contribution of impaired sensation in motor performance. Although it has been shown that somatosensory deficits in the lower extremities of children with spastic CP can negatively affect gait and balance, the effect of spasticity in the ankle has not been evaluated.
In this study, the investigators aimed to investigate the effects of BoNT injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic CP who are ambulatory without an assistive device in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin-A | Experimental | Drug: Botulinum toxin type-A (Onabotulinum toxin type-A), Other: Physical TherapyBotulinum toxin-A (Onabotulinum toxin type-A) injection with electrical stimulation guidance will be administered to spastic ankle plantar flexor muscles. After the injection, the patients will be included in the comprehensive physiotherapy program. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Patients diagnosed with hemiplegic cerebral palsy
- Age between 5-13 years
- MAS ≥ 2 spasticity in the affected ankle
- Gross Motor Function Classification System (GMFCS) level I-II
- Able to understand given commands
Key exclusion criteria (6 listed)
- Visual, vestibular and cognitive deficits
- Botulinum toxin A treatment within 6 months or having undergone an orthopaedic surgery 1 year prior to inclusion in the study
- Presence of fixed contracture or joint instability in the affected ankle
- Severe scoliosis (Cobb angle >40°)
- Uncontrolled epilepsy
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 |
|---|---|---|
| Botulinum toxin type-A (Onabotulinum toxin type-A)Botulinum toxin-A (Onabotulinum toxin type-A/Botox®) injection will be administered from three different points, two on the medial head of the gastrocnemius muscle and one point on the lateral head with total 3-6 units/kg dose, under the guidance of electrical stimulation for the detection of the target neuromuscular junction. | Drug | Botulinum toxin-A |
| Physical TherapyAfter the botulinum toxin-A injection, the patients will be included in the comprehensive physiotherapy program thrice a week for a total of 12 weeks. The physiotherapy program will be consisted of the ankle range of motion and stretching, strengthening of the antagonist muscles, proprioception exercises, functional walking training and static and dynamic balance training. | Other | Botulinum toxin-A |
Primary outcome
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) of NeuroCom Balance Master
Time frame: before intervention (T0)
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master
Time frame: 4th week after intervention (T1)
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test of NeuroCom Balance Master
Time frame: 3rd month after intervention (T2)
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test will be done by Balance Master device. Postural sway velocities (degree/second) will be recorded on the firm and foam surfaces with eyes opened and closed conditions of mCTSIB test. Higher scores mean worse static postural stability.
Light touch pressure treshold
Time frame: before intervention (T0)
Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.
Light touch pressure treshold
Time frame: 4th week after intervention (T1)
Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.
Light touch pressure treshold
Time frame: 3rd month after intervention (T2)
Light touch pressure (tactile) sensation will be assessed by using Semmes-Weinstein Monofilaments kit (Baseline, White Plains, New York, NY,USA) at the first and fifth metatarsal heads and heel of the plantar side of each foot. The light touch pressure threshold will be defined as the thinner monofilament value the participant correctly identified twice out of three trials for each application site. Higher scores mean worse tactile sensation.
21 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: before intervention (T0)
Modified Ashworth Scale (MAS)
Time frame: 4th week after intervention (T1)
Modified Ashworth Scale (MAS)
Time frame: 3rd month after intervention (T2)
Modified Tardieu Scale (MTS)
Time frame: before intervention (T0)
Modified Tardieu Scale (MTS)
Time frame: 4th week after intervention (T1)
Modified Tardieu Scale (MTS)
Time frame: 3rd month after intervention (T2)
Sit to Stand (STS) test of Neurocom Balance Master
Time frame: before intervention (T0)
Sit to Stand (STS) test of Neurocom Balance Master
Time frame: 4th week after intervention (T1)
Sit to Stand (STS) test of Neurocom Balance Master
Time frame: 3rd month after intervention (T2)
Step&Quick Turn (SQT) test of Neurocom Balance Master
Time frame: before intervention (T0)
Step&Quick Turn (SQT) test of Neurocom Balance Master
Time frame: 4th week after intervention (T1)
Step&Quick Turn (SQT) test of Neurocom Balance Master
Time frame: 3rd month after intervention (T2)
Two-point discrimination
Time frame: before intervention (T0)
Two-point discrimination
Time frame: 4th week after intervention (T1)
Two-point discrimination
Time frame: 3rd month after intervention (T2)
Selective Control Assessment of the Lower Extremity (SCALE)
Time frame: before intervention (T0)
Selective Control Assessment of the Lower Extremity (SCALE)
Time frame: 4th week after intervention (T1)
Selective Control Assessment of the Lower Extremity (SCALE)
Time frame: 3rd month after intervention (T2)
Timed Up and Go (TUG) test
Time frame: before intervention (T0)
Timed Up and Go (TUG) test
Time frame: 4th week after intervention (T1)
Timed Up and Go (TUG) test
Time frame: 3rd month after intervention (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- 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.
Evrim Karadag Saygi, Prof principal investigator
Marmara 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 Botulinum toxin type-A (Onabotulinum toxin type-A) and Physical Therapy in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Marmara 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sefa Kurt, MD (+905385159528, sefa.kurt@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) of NeuroCom Balance Master (time frame: before intervention (T0)). The study lists 6 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 2 Jul 2021.