Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy

NCT ID: NCT05136716

Last Updated: 2021-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2021-11-13

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.

Conditions

Cerebral Palsy; Hyperbaric Oxygen Therapy

Keywords

Spastic cerebral palsy; Hyperbaric oxygen therapy; Functional Balance; Gait parameters

Study Design

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

Study Groups

Control

Children in this group received traditional physical therapy

Group Type: ACTIVE_COMPARATOR

Traditional Physical Therapy

Intervention Type: OTHER

Stretching for tight muscles, strengthening for weak muscles, postural reactions training, proprioceptive training, and walking training were all part of the neurodevelopmental treatment plan.

Study

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

Group Type: EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type: DEVICE

HBO2 therapy at a pressure of 1.7 atm For 60 minutes, participants breathed 100% O2.

Interventions

Traditional Physical Therapy

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: OTHER

Hyperbaric oxygen therapy

HBO2 therapy at a pressure of 1.7 atm For 60 minutes, participants breathed 100% O2.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Batterjee Medical College

OTHER

Sponsor Role: lead

Responsible Party

Mohamed A. Abdel Ghafar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A. AbdelGhafar, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Batterjee Medical College

Locations

Batterjee Medical College

Jeddah, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

Hyperbaric and Cerebral Palsy

Identifier Type: -

Identifier Source: org_study_id