Clinical trial NCT04269798: The Effect of Functional Electrical Stimulation on Gait and Balance in Children With Hemiplegic Cerebral Palsy
Official title: The Effect of Functional Electrical Stimulation Technology on Gait and Balance Performance in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to evaluate the effect of FES on stimulation of the anterior tibial group by using the WalkAide foot drop stimulator on improving walking and balance abilities in children with hemiplegic CP.

Detailed description: The aim of this study will be to evaluate the effect of FES on improving walking and balance abilities in children with hemiplegic CP. Forty children with hemiplegic CP will be assigned randomly into two groups (A \& B). Control group (A) will receive conventional rehabilitation program for lower limb, balance and gait training. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to FES by using the WalkAide foot drop stimulator. Patients' evaluation will be carried out before and after training to assess walking ability and balance performance.

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.

Primary outcomes:
measure: Change from baseline spatial and temporal gait analysis at 3 months
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline postural stability at 3 months
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Maternity and Children Hospital
Study officials:
affiliation: Professor
name: Shamekh M El-Shamy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: