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Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy

Not Applicable
Completed
Conditions
Cerebral Palsy
Interventions
Other: TheraTogs Arm
Other: Traditional Treatment
Registration Number
NCT03037697
Lead Sponsor
Umm Al-Qura University
Brief Summary

The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy.

Detailed Description

The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy. Forty children with dyskinetic CP will be assigned randomly into two groups (A \& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions weekly/3 successive months. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to wearing Thera Togs soft orthotic undergarment. Patients evaluation will be carried out before and after the intervention programs to assess gait and balance performance using Noraxons myo pressure plate and Biodex balance system.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • The levels of gross motor function will be selected between levels I and II according to Gross Motor Function Classification System (GMFCS); have the ability to walk 10 m independently without an orthosis; should be cognitively competent and able to understand and follow instructions; height will be more than 100 cm to fit with the Biodex balance equipment.
Exclusion Criteria
  • If participants use an assistive mobility device; GMFCS levels III, IV, and V; fixed contractures of lower limb musculature; hip dislocation; significant spinal deformities.

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
TheraTogs ArmTheraTogs ArmTheraTogs 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, to allow the children to become acclimated to the system+ Traditional treatment 3 months
TheraTogs ArmTraditional TreatmentTheraTogs 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, to allow the children to become acclimated to the system+ Traditional treatment 3 months
Traditional Treatment ArmTraditional TreatmentTraditional Treatment Arm 1-Trunk control exercises 2-Core stability training 3-Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board 3 months
Primary Outcome Measures
NameTimeMethod
Change from baseline gait parameters at 3 monthsBaseline and 3 months post-intervention

Gait parameters will be evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).

Secondary Outcome Measures
NameTimeMethod
Change from baseline postural stability at 3 monthsBaseline and 3 months post-intervention

Postural stability will be evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).

Trial Locations

Locations (1)

Maternity and Children Hospital

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Mecca, Saudi Arabia

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