Cerebral PalsyNCT03037697
Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy
A study testing TheraTogs Arm and Traditional Treatment in people with Cerebral Palsy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- TheraTogs Arm and Traditional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2017to Dec 2019
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The levels of gross motor function will be selected between levels I and II according to Gross Motor Function Classification System (GMFCS); have the ability to walk 10 m independently without an orthosis; should be cognitively competent and able to understand and follow instructions; height will be more than 100 cm to fit with the Biodex balance equipment.
Who cannot join
- If participants use an assistive mobility device; GMFCS levels III, IV, and V; fixed contractures of lower limb musculature; hip dislocation; significant spinal deformities.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy.
Read the detailed description
The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy. Forty children with dyskinetic CP will be assigned randomly into two groups (A \& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions weekly/3 successive months. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to wearing Thera Togs soft orthotic undergarment. Patients evaluation will be carried out before and after the intervention programs to assess gait and balance performance using Noraxons myo pressure plate and Biodex balance system.
- Conditions
- Cerebral Palsy
- Being tested
- TheraTogs Arm, Traditional Treatment
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraTogs ArmOther
Also called Experimental
TheraTogs Arm Received Soft Orthotic undergarments
Traditional TreatmentOther
Traditional treatment to Dyskinetic CP
1- Trunk control exercises 2- Core stability training 3- Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board
| Study group | Role | What they receive |
|---|---|---|
| TheraTogs Arm | Experimental | TheraTogs Arm The participating children will wear TheraTogs orthotic undergarment and strapping as preparatory stage without application of any exercise program with gradually increasing the worn time till reaching the 8 hours per day, to allow the children to become acclimated to the system+ Traditional treatment 3 months Receives: Other: TheraTogs Arm; Other: Traditional Treatment |
| Traditional Treatment Arm | Active comparator | Traditional Treatment Arm
1-Trunk control exercises 2-Core stability training 3-Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board
3 months Receives: Other: Traditional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline gait parameters at 3 months
Gait parameters will be evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).
Measured: Baseline and 3 months post-intervention
Secondary outcomes (1)
Change from baseline postural stability at 3 months
Postural stability will be evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2019
- Study completionDec 2019
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
- Factorial
- 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, Shamekh Mohamed El-Shamy, Umm Al-Qura University
- Investigators
- Shamekh M El-Shamy, Ph.D, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037697
- Sponsor's protocol ID
- Umm Al-Qura University
- Status last verified
- Feb 2021
- First submitted
- 12 Jan 2017
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03037697
- Acronym / sponsor ID
- Umm Al-Qura University
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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.
The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy.
Detailed description
The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy. Forty children with dyskinetic CP will be assigned randomly into two groups (A \& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions weekly/3 successive months. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to wearing Thera Togs soft orthotic undergarment. Patients evaluation will be carried out before and after the intervention programs to assess gait and balance performance using Noraxons myo pressure plate and Biodex balance system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TheraTogs Arm | Experimental | Other: TheraTogs Arm, Other: Traditional TreatmentTheraTogs Arm The participating children will wear TheraTogs orthotic undergarment and strapping as preparatory stage without application of any exercise program with gradually increasing the worn time till reaching the 8 hours per day, to allow the children to become acclimated to the system+ Traditional treatment 3 months |
| Traditional Treatment Arm | Active comparator | Other: Traditional TreatmentTraditional Treatment Arm 1-Trunk control exercises 2-Core stability training 3-Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board 3 months |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The levels of gross motor function will be selected between levels I and II according to Gross Motor Function Classification System (GMFCS); have the ability to walk 10 m independently without an orthosis; should be cognitively competent and able to understand and follow instructions; height will be more than 100 cm to fit with the Biodex balance equipment.
Key exclusion criteria (1 listed)
- If participants use an assistive mobility device; GMFCS levels III, IV, and V; fixed contractures of lower limb musculature; hip dislocation; significant spinal deformities.
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 |
|---|---|---|
| TheraTogs ArmAlso: ExperimentalTheraTogs Arm Received Soft Orthotic undergarments | Other | TheraTogs Arm |
| Traditional TreatmentTraditional treatment to Dyskinetic CP 1- Trunk control exercises 2- Core stability training 3- Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board | Other | TheraTogs Arm, Traditional Treatment Arm |
Primary outcome
Change from baseline gait parameters at 3 months
Time frame: Baseline and 3 months post-intervention
Gait parameters will be evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).
1 secondary outcome
Change from baseline postural stability at 3 months
Time frame: Baseline and 3 months post-intervention
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 26 Feb 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.
Shamekh M El-Shamy, Ph.D principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraTogs Arm and Traditional Treatment 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 1 inclusion and 1 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 26 Feb 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 from baseline gait parameters at 3 months (time frame: Baseline and 3 months post-intervention). 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 26 Feb 2021.