Cerebral PalsyNCT05020834
Effect of Functional Electrical Stimulation Versus TheraTogs on Treatment of Children With Hemiplegic Cerebral Palsy.
A study testing Functional Electrical Stimulation and TheraTogs Orthotic Undergarment in people with Cerebral Palsy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
To compare the effect of functional electrical stimulation (FES) versus TheraTogs on Gait and Balance in children with hemiplegic CP. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Functional Electrical Stimulation and TheraTogs Orthotic Undergarment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Jan 2021to 15 May 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their weight should be less than 40 kg.
- The spasticity degrees of the affected lower limb will range between grades (1, 1+ \& 2) according to Modified Ashworth Scale (MAS).
- Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II.
- They can walk 10 min conditionally without an orthosis.
- Ought to be intellectually skilled and ready to comprehend and take after directions.
- They will have neither serious nor recurring medical complications.
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- Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance.
- No serious hip \& knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40º .
- Peroneal nerve and the proximal leg muscles ought to be in place.
- They ought to have no significant issues influencing balance other than spasticity.
Who cannot join
- Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
- Children with visual, auditory or perceptual deficits.
- Children with surgical interference for the lower limb.
- Children with seizures or epilepsy.
- Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
- Children with pacemakers or other diseases that are contraindicated by electrical stimulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Functional Electrical Stimulation Versus TheraTogs on Gait and Balance in Children With Hemiplegic Cerebral Palsy
To compare the effect of functional electrical stimulation (FES) versus TheraTogs on Gait and Balance in children with hemiplegic CP.
Read the detailed description
The aim of this study was to evaluate the effect of FES versus TheraTogs on Gait and Balance in children with hemiplegic CP. Thirty children with hemiplegic CP will be assigned randomly into two groups (A \& B). Group A received FES by using the WalkAide foot drop stimulator while group B received TheraTogs. Patients' evaluation will be carried out before and after training to assess gait and balance performance.
- Conditions
- Cerebral Palsy
- Being tested
- Functional Electrical Stimulation, TheraTogs Orthotic Undergarment
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationOther
Functional Electrical Stimulation Group received 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months.
TheraTogs Orthotic UndergarmentOther
TheraTogs Arm The participating children worn 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.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation Group | Experimental | Functional Electrical Stimulation Group received 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months. Receives: Other: Functional Electrical Stimulation |
| TheraTogs Group | 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. Receives: Other: TheraTogs Orthotic Undergarment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline spatial and temporal gait parameters at 3 months
Gait parameters were evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). For the purpose of this study four commonly used and reliable gait parameters were examined: stride length, step length, velocity, cadence, and stance and swing phase percentage.
Measured: Baseline and 3 months post-intervention
Change from baseline postural stability at 3 months
Postural stability were 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 posted25 Aug 2021
- Study start11 Jan 2021
- Primary completion15 May 2021
- Study completion15 May 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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 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 Elshamy, Ph.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020834
- Sponsor's protocol ID
- Umm Al-Qura
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Electrical Stimulation Versus TheraTogs on Gait and Balance in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05020834
- Acronym / sponsor ID
- Umm Al-Qura
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 25 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.
To compare the effect of functional electrical stimulation (FES) versus TheraTogs on Gait and Balance in children with hemiplegic CP.
Detailed description
The aim of this study was to evaluate the effect of FES versus TheraTogs on Gait and Balance in children with hemiplegic CP. Thirty children with hemiplegic CP will be assigned randomly into two groups (A \& B). Group A received FES by using the WalkAide foot drop stimulator while group B received TheraTogs. Patients' evaluation will be carried out before and after training to assess gait and balance performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation Group | Experimental | Other: Functional Electrical StimulationFunctional Electrical Stimulation Group received 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months. |
| TheraTogs Group | Experimental | Other: TheraTogs Orthotic UndergarmentTheraTogs 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. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Their weight should be less than 40 kg.
- The spasticity degrees of the affected lower limb will range between grades (1, 1+ \& 2) according to Modified Ashworth Scale (MAS).
- Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II.
- They can walk 10 min conditionally without an orthosis.
- Ought to be intellectually skilled and ready to comprehend and take after directions.
Key exclusion criteria (6 listed)
- Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
- Children with visual, auditory or perceptual deficits.
- Children with surgical interference for the lower limb.
- Children with seizures or epilepsy.
- Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
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 |
|---|---|---|
| Functional Electrical StimulationFunctional Electrical Stimulation Group received 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months. | Other | Functional Electrical Stimulation Group |
| TheraTogs Orthotic UndergarmentTheraTogs Arm The participating children worn 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. | Other | TheraTogs Group |
Primary outcome
Change from baseline spatial and temporal gait parameters at 3 months
Time frame: Baseline and 3 months post-intervention
Gait parameters were evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). For the purpose of this study four commonly used and reliable gait parameters were examined: stride length, step length, velocity, cadence, and stance and swing phase percentage.
Change from baseline postural stability at 3 months
Time frame: Baseline and 3 months post-intervention
Postural stability were evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).
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 25 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.
Shamekh M Elshamy, Ph.D. principal investigator
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 Functional Electrical Stimulation and TheraTogs Orthotic Undergarment 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 10 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: finished, as of the sponsor's last update on 25 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 from baseline spatial and temporal gait parameters at 3 months (time frame: Baseline and 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2021.