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

NCT03037697 | Completed DMC

• 1 other identifier: Umm Al-Qura University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Change from baseline gait parameters at 3 months

  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).

  Baseline and 3 months post-intervention

Secondary Outcomes (1)

• Change from baseline postural stability at 3 months

  Baseline and 3 months post-intervention

Study Arms (2)

TheraTogs Arm

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, to allow the children to become acclimated to the system+ Traditional treatment 3 months

Other: TheraTogs Arm; Other: Traditional Treatment

Traditional Treatment Arm

ACTIVE COMPARATOR

Traditional 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

Other: Traditional Treatment

Interventions

TheraTogs Arm OTHER

TheraTogs Arm Received Soft Orthotic undergarments

Also known as: Experimental

TheraTogs Arm

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

TheraTogs Arm; Traditional Treatment Arm

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• If participants use an assistive mobility device; GMFCS levels III, IV, and V; fixed contractures of lower limb musculature; hip dislocation; significant spinal deformities.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Maternity and Children Hospital

Mecca, 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 El-Shamy, Ph.D

  Associate 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: Associate Professor

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 31, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)