An interventional study of Functional Electrical Stimulation and TheraTogs Orthotic Undergarment in Cerebral Palsy, sponsored by Umm Al-Qura University. Completed at 1 site in Saudi Arabia. Open to participants aged 8 Years to 10 Years. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by Umm Al-Qura University · Not applicable, Interventional, and Treatment
To compare the effect of functional electrical stimulation (FES) versus TheraTogs on Gait and Balance in children with hemiplegic CP.
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.
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This study's enrollment of 30 is close to the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
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Exclusion Criteria:
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 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
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 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.
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.
Time frame: 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).
Time frame: Baseline and 3 months post-intervention
Plan to share: No
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Umm Al-Qura University