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Completed

NCT Number: NCT03037697

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternity and Children Hospital

Mecca, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TheraTogs Arm

Other

TheraTogs Arm Received Soft Orthotic undergarments

Other names: Experimental

traditional treatment

Other

Traditional treatment to Dyskinetic CP

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

Primary outcomes

  1. Change from baseline gait parameters at 3 months

    Time frame: Baseline 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 outcomes

  1. Change from baseline postural stability at 3 months

    Time frame: Baseline 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).

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2017
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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