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Effect of Functional Electrical Stimulation Versus TheraTogs on Treatment of Children With Hemiplegic Cerebral Palsy.

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Functional Electrical Stimulation
TheraTogs Orthotic Undergarment
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

8 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Maternity and Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Functional Electrical Stimulation Group

TheraTogs Group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
August 18, 2021
Last Updated
August 24, 2021
Sponsor
Umm Al-Qura University
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1. Study Identification

Unique Protocol Identification Number
NCT05020834
Brief Title
Effect of Functional Electrical Stimulation Versus TheraTogs on Treatment of Children With Hemiplegic Cerebral Palsy.
Official Title
Effect of Functional Electrical Stimulation Versus TheraTogs on Gait and Balance in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional Electrical Stimulation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
TheraTogs Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Functional Electrical Stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
TheraTogs Orthotic Undergarment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline spatial and temporal gait parameters at 3 months
Description
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.
Time Frame
Baseline and 3 months post-intervention
Title
Change from baseline postural stability at 3 months
Description
Postural stability were evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).
Time Frame
Baseline and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamekh M Elshamy, Ph.D.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternity and Children Hospital
City
Mecca
ZIP/Postal Code
715
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Functional Electrical Stimulation Versus TheraTogs on Treatment of Children With Hemiplegic Cerebral Palsy.

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