Cerebral PalsyNCT04990193
The Effect of Soft Orthoses on Balance and Gait Performance in Children With Cerebral Palsy
A study testing Conventional Physical Therapy Protocol and TheraTog orthotic undergarment with its strapping system in people with Cerebral Palsy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
Most of the available studies that are relevant to motor rehabilitation for children with dyskinetic type of cerebral palsy are few and are comprised of small numbers of children. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Conventional Physical Therapy Protocol and TheraTog orthotic undergarment with its strapping system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2017to 1 Mar 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of a confirmed diagnosis of dyskinetic cerebral palsy of choreoathetosis type were selected to participate in this study.
- Children (of both sexes) were between 12 and 16 years old were included .
- Their height and weight were more than 100 cm and 20 Kg respectively to be eligible for the evaluation process on the Biodex stability system.
- Children were able to comprehend and follow orders.
- Their gross motor development levels, as measured by Gross Motor Function Classification System, were between levels I and II.
- Throughout the study period, participating children were not subjected to any other physical therapy programs except the assigned treatment protocol.
Who cannot join
- Children were excluded from this study if they had inflexible spinal deformities interfering with spinal and limbs functional mobility.
- Children were also excluded if their skin were sensitive or inflamed to any materials used.
- Children who had seizures, perceptual disorders, visual problems, and auditory deficits did not participate as well.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Soft Orthoses and Strapping on Balance and Gait Performance in Children With Cerebral Palsy: A Randomized Controlled Trial
Most of the available studies that are relevant to motor rehabilitation for children with dyskinetic type of cerebral palsy are few and are comprised of small numbers of children. Further researches are necessary to explore new conservative therapeutic protocols and techniques that should contribute to control disorganized movement, handle postural asymmetry, maintain postural stability, and improve gait performance. Therefore, the objective of this study was to examine the effectiveness of soft orthosis and strapping system on balance, and gait performance in children with dyskinetic cerebral palsy.
Read the detailed description
Dyskinetic type of cerebral palsy typically results from extrapyramidal and basal ganglia damage. The most common dyskinetic movement disorders are choreoathetosis and dystonia. Their clinical features include fluctuation of muscle tone, involuntary and in-coordinated movement, and posture instability. These features have significant negative impacts on the children's quality of life and performance of daily activities. Management strategy for children with dyskinesia requires both medical and rehabilitative treatment. Most of the available studies that are relevant to their motor rehabilitation are few and comprised of small numbers of children. The therapeutic modalities currently used for their rehabilitation require more evidence to certain their efficacy. Moreover, further researches are necessary to explore new conservative therapeutic protocols and techniques that should correct postural instability and improve the poor mobility of these children The objective of this study was to examine the effectiveness of an orthotic undergarment which is (TheraTog orthosis), and its strapping system on balance and gait performance in children with dyskinetic cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Conventional Physical Therapy Protocol, TheraTog orthotic undergarment with its strapping system
- Keywords
- Balance, Gait, Strapping, Orthoses
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical Therapy ProtocolOther
The conventional physical therapy protocol was designed to improve axial stability and trunk steadiness during standing and walking. The conventional therapeutic protocol for every child was 3 sessions/week for 12 consecutive weeks. Every treatment session was conducted for 2 hours with a 15-minutes rest between the two training hours.
TheraTog orthotic undergarment with its strapping systemOther
TheraTog orthotic undergarment with its strapping system was applied for eight hours every day for twelve consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Children in the control group received the conventional physical therapy protocol which was designed to improve axial stability and trunk steadiness during standing and walking. Receives: Other: Conventional Physical Therapy Protocol |
| Study group | Experimental | The children in the study group received the conventional protocol given to the control group. Moreover, they wore TheraTog orthotic undergarment with its strapping system eight hours every day for twelve consecutive weeks. Receives: Other: Conventional Physical Therapy Protocol; Other: TheraTog orthotic undergarment with its strapping system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assessed the change in postural stability)
The Biodex Balance System was used to assess the Change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the children's ability to control their postural balance stability in all directions. High values % represent less stability and the children had difficulty in balance control. On the other hand lower values were indicative of a better balance control.
Measured: Data was collected at baseline, and 12 weeks after intervention commencement.
Change in the Pediatric Balance Scale score (scale that assessed the change in balance performance )
The Pediatric Balance Scale is a valid and reliable test to assess and re-assess balance deficits in children with mild and moderate motor disabilities. The test includes fourteen tasks that evaluate balance abilities and motor performance in children. 0-4 is the rating score for each item, where zero is the lowest score and 56 is the highest possible score for all tasks that indicate the best balance and motor performance ever.
Measured: Data was collected at baseline, and 12 weeks after intervention commencement.
Change in the gait parameter (step length) (This parameter indicated the change of gait performance).
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: step length (cm).
Measured: Data was collected at baseline, and 12 weeks after intervention commencement.
Change in the gait parameter (gait cycle time) (This parameter indicated the change of gait performance).
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: gait cycle time (seconds).
Measured: Data was collected at baseline, and 12 weeks after intervention commencement.
Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: cadence (steps/ minute).
Measured: Data was collected at baseline, and 12 weeks after intervention commencement.
Change in the gait parameter (velocity) (This parameter indicated the change of gait performance).
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: velocity (meter / second).
Measured: Data was collected at baseline, and 12 weeks after intervention commencement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 May 2017
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
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.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Abd El Kafy, Umm Al-Qura University
- Investigators
- Ehab M Abd El Kafy, Ph.D, Principal investigator, Faculty of Applied Medical Sciences - Umm Al Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990193
- Sponsor's protocol ID
- 19-MED-1-0004
- Status last verified
- Jul 2021
- First submitted
- 18 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- 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 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soft Orthoses and Strapping on Balance and Gait Performance in Children With Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04990193
- Acronym / sponsor ID
- 19-MED-1-0004
- Conditions
- Cerebral Palsy
- Keywords
- Balance, Gait, Strapping, Orthoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 4 Aug 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.
Most of the available studies that are relevant to motor rehabilitation for children with dyskinetic type of cerebral palsy are few and are comprised of small numbers of children. Further researches are necessary to explore new conservative therapeutic protocols and techniques that should contribute to control disorganized movement, handle postural asymmetry, maintain postural stability, and improve gait performance. Therefore, the objective of this study was to examine the effectiveness of soft orthosis and strapping system on balance, and gait performance in children with dyskinetic cerebral palsy.
Detailed description
Dyskinetic type of cerebral palsy typically results from extrapyramidal and basal ganglia damage. The most common dyskinetic movement disorders are choreoathetosis and dystonia. Their clinical features include fluctuation of muscle tone, involuntary and in-coordinated movement, and posture instability. These features have significant negative impacts on the children's quality of life and performance of daily activities. Management strategy for children with dyskinesia requires both medical and rehabilitative treatment. Most of the available studies that are relevant to their motor rehabilitation are few and comprised of small numbers of children. The therapeutic modalities currently used for their rehabilitation require more evidence to certain their efficacy. Moreover, further researches are necessary to explore new conservative therapeutic protocols and techniques that should correct postural instability and improve the poor mobility of these children The objective of this study was to examine the effectiveness of an orthotic undergarment which is (TheraTog orthosis), and its strapping system on balance and gait performance in children with dyskinetic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Conventional Physical Therapy ProtocolChildren in the control group received the conventional physical therapy protocol which was designed to improve axial stability and trunk steadiness during standing and walking. |
| Study group | Experimental | Other: Conventional Physical Therapy Protocol, Other: TheraTog orthotic undergarment with its strapping systemThe children in the study group received the conventional protocol given to the control group. Moreover, they wore TheraTog orthotic undergarment with its strapping system eight hours every day for twelve consecutive weeks. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children of a confirmed diagnosis of dyskinetic cerebral palsy of choreoathetosis type were selected to participate in this study.
- Children (of both sexes) were between 12 and 16 years old were included .
- Their height and weight were more than 100 cm and 20 Kg respectively to be eligible for the evaluation process on the Biodex stability system.
- Children were able to comprehend and follow orders.
- Their gross motor development levels, as measured by Gross Motor Function Classification System, were between levels I and II.
Key exclusion criteria (3 listed)
- Children were excluded from this study if they had inflexible spinal deformities interfering with spinal and limbs functional mobility.
- Children were also excluded if their skin were sensitive or inflamed to any materials used.
- Children who had seizures, perceptual disorders, visual problems, and auditory deficits did not participate as well.
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 Physical Therapy ProtocolThe conventional physical therapy protocol was designed to improve axial stability and trunk steadiness during standing and walking. The conventional therapeutic protocol for every child was 3 sessions/week for 12 consecutive weeks. Every treatment session was conducted for 2 hours with a 15-minutes rest between the two training hours. | Other | Control group, Study group |
| TheraTog orthotic undergarment with its strapping systemTheraTog orthotic undergarment with its strapping system was applied for eight hours every day for twelve consecutive weeks. | Other | Study group |
Primary outcome
Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assessed the change in postural stability)
Time frame: Data was collected at baseline, and 12 weeks after intervention commencement.
The Biodex Balance System was used to assess the Change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the children's ability to control their postural balance stability in all directions. High values % represent less stability and the children had difficulty in balance control. On the other hand lower values were indicative of a better balance control.
Change in the Pediatric Balance Scale score (scale that assessed the change in balance performance )
Time frame: Data was collected at baseline, and 12 weeks after intervention commencement.
The Pediatric Balance Scale is a valid and reliable test to assess and re-assess balance deficits in children with mild and moderate motor disabilities. The test includes fourteen tasks that evaluate balance abilities and motor performance in children. 0-4 is the rating score for each item, where zero is the lowest score and 56 is the highest possible score for all tasks that indicate the best balance and motor performance ever.
Change in the gait parameter (step length) (This parameter indicated the change of gait performance).
Time frame: Data was collected at baseline, and 12 weeks after intervention commencement.
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: step length (cm).
Change in the gait parameter (gait cycle time) (This parameter indicated the change of gait performance).
Time frame: Data was collected at baseline, and 12 weeks after intervention commencement.
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: gait cycle time (seconds).
Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).
Time frame: Data was collected at baseline, and 12 weeks after intervention commencement.
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: cadence (steps/ minute).
Change in the gait parameter (velocity) (This parameter indicated the change of gait performance).
Time frame: Data was collected at baseline, and 12 weeks after intervention commencement.
An electronic walkway that connected to a portable computer was used to measure the following gait parameter: velocity (meter / second).
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 4 Aug 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.
Ehab M Abd El Kafy, Ph.D principal investigator
Faculty of Applied Medical Sciences - Umm Al Qura 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 Physical Therapy Protocol and TheraTog orthotic undergarment with its strapping system in people with Cerebral Palsy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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 6 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 4 Aug 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 Saudi Arabia. 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?
Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assessed the change in postural stability) (time frame: Data was collected at baseline, and 12 weeks after intervention commencement.). 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 4 Aug 2021.