Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy

Long Term Effect of Hyperbaric Oxygen Therapy on Gait and Functional Balance Skills in Cerebral Palsy

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Hyperbaric Oxygen Therapy
• Intervention / Treatment: Other: Traditional Physical Therapy; Device: Hyperbaric oxygen therapy

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Batterjee Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; Children in this group received traditional physical therapy	Other: 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.
EXPERIMENTAL: Study; Children in this group received the same traditional physical therapy plus hyperbaric oxygen therapy	Device: Hyperbaric oxygen therapy; HBO2 therapy at a pressure of 1.7 atm For 60 minutes, participants breathed 100% O2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Velocity (cm/s)	Change of the velocity was measured using GAITRite System	6 months
Stride Length (cm)	Change of the stride length was measured using GAITRite System	6 months
Double leg support (% of gait cycle)	Change of the double leg support was measured using GAITRite System	6 months
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	6 months

Collaborators and Investigators

• Sponsor: Batterjee Medical College
• Investigators: Principal Investigator: Mohamed A. AbdelGhafar, Ph.D, Batterjee Medical College

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2020
• Primary Completion (ACTUAL): October 31, 2021
• Study Completion (ACTUAL): November 13, 2021

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (ACTUAL): November 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2021
• Last Update Submitted That Met QC Criteria: November 27, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Hyperbaric oxygen therapy; Gait parameters; Spastic cerebral palsy; Functional Balance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: Hyperbaric and Cerebral Palsy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No