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

NCT ID: NCT04990193

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2021-03-01

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.

Detailed Description

Dyskinetic type of cerebral palsy typically results from extrapyramidal and basal ganglia damage. The most common dyskinetic movement disorders are choreoathetosis and dystonia. Their clinical features include fluctuation of muscle tone, involuntary and in-coordinated movement, and posture instability. These features have significant negative impacts on the children's quality of life and performance of daily activities. Management strategy for children with dyskinesia requires both medical and rehabilitative treatment. Most of the available studies that are relevant to their motor rehabilitation are few and comprised of small numbers of children. The therapeutic modalities currently used for their rehabilitation require more evidence to certain their efficacy. Moreover, further researches are necessary to explore new conservative therapeutic protocols and techniques that should correct postural instability and improve the poor mobility of these children The objective of this study was to examine the effectiveness of an orthotic undergarment which is (TheraTog orthosis), and its strapping system on balance and gait performance in children with dyskinetic cerebral palsy.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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.

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy Protocol

Intervention Type: 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.

Study group

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.

Group Type: EXPERIMENTAL

Conventional Physical Therapy Protocol

Intervention Type: 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.

TheraTog orthotic undergarment with its strapping system

Intervention Type: OTHER

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

Interventions

Conventional Physical Therapy Protocol

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.

Intervention Type: OTHER

TheraTog orthotic undergarment with its strapping system

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umm Al-Qura University

OTHER

Sponsor Role: lead

Responsible Party

Ehab Mohamed Abd El Kafy

Professor of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ehab M Abd El Kafy, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Applied Medical Sciences - Umm Al Qura University

Locations

Umm Al Qura University

Mecca, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

19-MED-1-0004

Identifier Type: -

Identifier Source: org_study_id