Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy; Hyperbaric Oxygen Therapy
• Interventions: Other: Traditional Physical Therapy; Device: Hyperbaric oxygen therapy

• Registration Number: NCT05136716
• Lead Sponsor: Batterjee Medical College

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.

Study Timeline

• Study Start: 2020-09-02
• Primary Completion: 2021-10-31
• Status Verified: 2021-11
• Study Completion: 2021-11-13
• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-27
• Study First Posted: 2021-11-29
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Traditional Physical Therapy	Children in this group received traditional physical therapy
Study	Hyperbaric oxygen therapy	Children in this group received the same traditional physical therapy plus hyperbaric oxygen therapy

Primary Outcome Measures

Name	Time	Method
Stride Length (cm)	6 months	Change of the stride length was measured using GAITRite System
Double leg support (% of gait cycle)	6 months	Change of the double leg support was measured using GAITRite System
Velocity (cm/s)	6 months	Change of the velocity was measured using GAITRite System
Functional Balance skills (score)	6 months	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

Trial Locations

Locations (1)

Batterjee Medical College; 🇸🇦 Jeddah, Saudi Arabia