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Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy

Primary Purpose

Cerebral Palsy, Hyperbaric Oxygen Therapy

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Traditional Physical Therapy
Hyperbaric oxygen therapy
Sponsored by
Batterjee Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Spastic cerebral palsy, Hyperbaric oxygen therapy, Functional Balance, Gait parameters

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • medically free by their doctor.
  • being able to tolerate a hyperbaric oxygen hood.
  • being able to blow through a straw, or swallow on command.
  • having spasticity ranging from 1 to 1+ on the Modified Ashworth Scale
  • level I or II on the Gross Motor Function Classification System (GMFCS).
  • being capable of understanding and following instructions

Exclusion Criteria:

  • Previous HBO treatments.
  • botulinum toxin A treatments.
  • thoracic surgery within 6 months.
  • major changes to spasticity medications within 3 months.
  • unstable epilepsy.
  • pulmonary dysfunction.
  • cardiovascular disease

Sites / Locations

  • Batterjee Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Study

Arm Description

Children in this group received traditional physical therapy

Children in this group received the same traditional physical therapy plus hyperbaric oxygen therapy

Outcomes

Primary Outcome Measures

Velocity (cm/s)
Change of the velocity was measured using GAITRite System
Stride Length (cm)
Change of the stride length was measured using GAITRite System
Double leg support (% of gait cycle)
Change of the double leg support was measured using GAITRite System
Functional Balance skills (score)
Change of balance scores was measured using pediatric balance scale. PBS collect scores for the 14 tasks assessed. The tasks are scored on a five-point scale (0, 1, 2, 3 or 4), with zero denoting an inability to perform the activity without assistance and four denoting the ability to perform the task with complete independence. Score range from 0 to 56, with higher scores indicating better postural control

Secondary Outcome Measures

Full Information

First Posted
November 16, 2021
Last Updated
November 27, 2021
Sponsor
Batterjee Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05136716
Brief Title
Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy
Official Title
Long Term Effect of Hyperbaric Oxygen Therapy on Gait and Functional Balance Skills in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
November 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Batterjee Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Abnormal gait is a common issue in children with CP. As a result of motor weakness and a lack of voluntary motor control. Furthermore, gait in children with cerebral palsy is characterized by a slower walking speed, a shorter stride length, and more time spent in double support. Deficits in postural control constitute a major limitation to the motor development in children with CP. The performance of static and dynamic tasks, such as sitting, standing, and walking, is limited in these children due to postural instability. Postural control deficits in CP are caused by altered sensory processing, motor impairment, and biomechanical alignment, which result in altered neuromuscular responses. HBO2 therapeutic benefits in CP are attributed to an increase in dissolved oxygen in plasma and tissue, which aids tissue regeneration, So, the purpose of this study was to investigate the long-term effects of hyperbaric oxygen therapy on spatiotemporal gait parameters and functional balance skills in children with CP.
Detailed Description
This was a randomized clinical trial. Thirty-nine children with spastic cerebral palsy with ages ranging from 5 to 10 years referred from local pediatric rehabilitation centers participated in this study. All children were classified randomly using sealed envelopes into two groups (Control and Study groups). The children in the control group received traditional physical therapy and the study group received the same traditional physical therapy in addition to hyperbaric oxygen therapy. Written informed consent from the child's legal guardian was obtained. The study was authorized by the Ethics Committee for Research at Cairo University in accordance with the ethical standards of the Declaration of Helsinki. PBS was used to assess functional balance and GAITRite was used to assess spatiotemporal gait parameters. Measurements of functional balance and spatiotemporal gait parameters were taken three times: at the start of the intervention, eight weeks later, and six months after cessation of HPO2 therapy to assess the long-term effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hyperbaric Oxygen Therapy
Keywords
Spastic cerebral palsy, Hyperbaric oxygen therapy, Functional Balance, Gait parameters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Children in this group received traditional physical therapy
Arm Title
Study
Arm Type
Experimental
Arm Description
Children in this group received the same traditional physical therapy plus hyperbaric oxygen therapy
Intervention Type
Other
Intervention Name(s)
Traditional Physical Therapy
Intervention Description
Stretching for tight muscles, strengthening for weak muscles, postural reactions training, proprioceptive training, and walking training were all part of the neurodevelopmental treatment plan.
Intervention Type
Device
Intervention Name(s)
Hyperbaric oxygen therapy
Intervention Description
HBO2 therapy at a pressure of 1.7 atm For 60 minutes, participants breathed 100% O2.
Primary Outcome Measure Information:
Title
Velocity (cm/s)
Description
Change of the velocity was measured using GAITRite System
Time Frame
6 months
Title
Stride Length (cm)
Description
Change of the stride length was measured using GAITRite System
Time Frame
6 months
Title
Double leg support (% of gait cycle)
Description
Change of the double leg support was measured using GAITRite System
Time Frame
6 months
Title
Functional Balance skills (score)
Description
Change of balance scores was measured using pediatric balance scale. PBS collect scores for the 14 tasks assessed. The tasks are scored on a five-point scale (0, 1, 2, 3 or 4), with zero denoting an inability to perform the activity without assistance and four denoting the ability to perform the task with complete independence. Score range from 0 to 56, with higher scores indicating better postural control
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: medically free by their doctor. being able to tolerate a hyperbaric oxygen hood. being able to blow through a straw, or swallow on command. having spasticity ranging from 1 to 1+ on the Modified Ashworth Scale level I or II on the Gross Motor Function Classification System (GMFCS). being capable of understanding and following instructions Exclusion Criteria: Previous HBO treatments. botulinum toxin A treatments. thoracic surgery within 6 months. major changes to spasticity medications within 3 months. unstable epilepsy. pulmonary dysfunction. cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A. AbdelGhafar, Ph.D
Organizational Affiliation
Batterjee Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Batterjee Medical College
City
Jeddah
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy

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