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

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ClinicalTrials.gov Identifier: NCT03037697
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Shamekh Mohamed El-Shamy, 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: TheraTogs Arm Other: Traditional Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy
Study Start Date : January 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TheraTogs Arm
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
TheraTogs Arm Received Soft Orthotic undergarments
Other Name: Experimental

Other: Traditional Treatment

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


Active Comparator: Traditional Treatment Arm

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

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 Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037697


Contacts
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Contact: Shamekh M El-Shamy, Ph. D. +966542327247 ext 3468 smshamy@uqu.edu.sa

Locations
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Saudi Arabia
Maternity and Children Hospital Recruiting
Mecca, Saudi Arabia
Contact: Shamekh M El-Shamy, Ph.D         
Sponsors and Collaborators
Umm Al-Qura University
Investigators
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Principal Investigator: Shamekh M El-Shamy, Ph.D Associate Professor

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Responsible Party: Shamekh Mohamed El-Shamy, Associate Professor, Umm Al-Qura University
ClinicalTrials.gov Identifier: NCT03037697     History of Changes
Other Study ID Numbers: Umm Al-Qura University
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases