The Effect of Soft Orthoses on Balance and Gait Performance in Children With Cerebral Palsy

NCT04990193 | Completed

• 1 other identifier: 19-MED-1-0004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Most of the available studies that are relevant to motor rehabilitation for children with dyskinetic type of cerebral palsy are few and are comprised of small numbers of children. Further researches are necessary to explore new conservative therapeutic protocols and techniques that should contribute to control disorganized movement, handle postural asymmetry, maintain postural stability, and improve gait performance. Therefore, the objective of this study was to examine the effectiveness of soft orthosis and strapping system on balance, and gait performance in children with dyskinetic cerebral palsy.

Conditions

Cerebral Palsy

Keywords

Balance; Gait; Strapping; Orthoses

Outcome Measures

Primary Outcomes (6)

• Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assessed the change in postural stability)

  The Biodex Balance System was used to assess the Change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the children's ability to control their postural balance stability in all directions. High values % represent less stability and the children had difficulty in balance control. On the other hand lower values were indicative of a better balance control.

  Data was collected at baseline, and 12 weeks after intervention commencement.

• Change in the Pediatric Balance Scale score (scale that assessed the change in balance performance )

  The Pediatric Balance Scale is a valid and reliable test to assess and re-assess balance deficits in children with mild and moderate motor disabilities. The test includes fourteen tasks that evaluate balance abilities and motor performance in children. 0-4 is the rating score for each item, where zero is the lowest score and 56 is the highest possible score for all tasks that indicate the best balance and motor performance ever.

  Data was collected at baseline, and 12 weeks after intervention commencement.

• Change in the gait parameter (step length) (This parameter indicated the change of gait performance).

  An electronic walkway that connected to a portable computer was used to measure the following gait parameter: step length (cm).

  Data was collected at baseline, and 12 weeks after intervention commencement.

• Change in the gait parameter (gait cycle time) (This parameter indicated the change of gait performance).

  An electronic walkway that connected to a portable computer was used to measure the following gait parameter: gait cycle time (seconds).

  Data was collected at baseline, and 12 weeks after intervention commencement.

• Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).

  An electronic walkway that connected to a portable computer was used to measure the following gait parameter: cadence (steps/ minute).

  Data was collected at baseline, and 12 weeks after intervention commencement.

• Change in the gait parameter (velocity) (This parameter indicated the change of gait performance).

  An electronic walkway that connected to a portable computer was used to measure the following gait parameter: velocity (meter / second).

  Data was collected at baseline, and 12 weeks after intervention commencement.

Study Arms (2)

Control group

ACTIVE COMPARATOR

Children in the control group received the conventional physical therapy protocol which was designed to improve axial stability and trunk steadiness during standing and walking.

Other: Conventional Physical Therapy Protocol

Study group

EXPERIMENTAL

The children in the study group received the conventional protocol given to the control group. Moreover, they wore TheraTog orthotic undergarment with its strapping system eight hours every day for twelve consecutive weeks.

Other: Conventional Physical Therapy Protocol; Other: TheraTog orthotic undergarment with its strapping system

Interventions

Conventional Physical Therapy Protocol OTHER

The conventional physical therapy protocol was designed to improve axial stability and trunk steadiness during standing and walking. The conventional therapeutic protocol for every child was 3 sessions/week for 12 consecutive weeks. Every treatment session was conducted for 2 hours with a 15-minutes rest between the two training hours.

Control group; Study group

TheraTog orthotic undergarment with its strapping system OTHER

TheraTog orthotic undergarment with its strapping system was applied for eight hours every day for twelve consecutive weeks.

Study group

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of a confirmed diagnosis of dyskinetic cerebral palsy of choreoathetosis type were selected to participate in this study.
• Children (of both sexes) were between 12 and 16 years old were included .
• Their height and weight were more than 100 cm and 20 Kg respectively to be eligible for the evaluation process on the Biodex stability system.
• Children were able to comprehend and follow orders.
• Their gross motor development levels, as measured by Gross Motor Function Classification System, were between levels I and II.
• Throughout the study period, participating children were not subjected to any other physical therapy programs except the assigned treatment protocol.

You may not qualify if:

• Children were excluded from this study if they had inflexible spinal deformities interfering with spinal and limbs functional mobility.
• Children were also excluded if their skin were sensitive or inflamed to any materials used.
• Children who had seizures, perceptual disorders, visual problems, and auditory deficits did not participate as well.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al Qura University

Mecca, 21955, 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

• Ehab M Abd El Kafy, Ph.D

  Faculty of Applied Medical Sciences - Umm Al Qura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: August 4, 2021
• Study Start: May 1, 2017
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)