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

Cerebral Palsy Clinical Trial

Official title:

Effect of Functional Electrical Stimulation Versus TheraTogs on Gait and Balance in Children With Hemiplegic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020834
• Other study ID #: Umm Al-Qura
• Status: Completed
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: May 15, 2021

Study information

• Verified date: August 2021
• Source: Umm Al-Qura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effect of functional electrical stimulation (FES) versus TheraTogs on Gait and Balance in children with hemiplegic CP.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Functional Electrical Stimulation
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 Undergarment
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.

Locations

Country	Name	City	State
Saudi Arabia	Maternity and Children Hospital	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 3 months post-intervention
Primary	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).	Baseline and 3 months post-intervention