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

NCT05020834 | Completed DMC

• 1 other identifier: Umm Al-Qura
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

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.

Other: TheraTogs Orthotic Undergarment

Interventions

Functional Electrical Stimulation OTHER

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.

Functional Electrical Stimulation Group

TheraTogs Orthotic Undergarment OTHER

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.

TheraTogs Group

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Maternity and Children Hospital

Mecca, 715, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shamekh M Elshamy, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: January 11, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)