Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy

NCT05136716 | Completed

• 1 other identifier: Hyperbaric and Cerebral Palsy
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Hyperbaric Oxygen Therapy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

Children in this group received traditional physical therapy

Other: Traditional Physical Therapy

Study

EXPERIMENTAL

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

Device: Hyperbaric oxygen therapy

Interventions

Traditional Physical Therapy 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.

Control

Hyperbaric oxygen therapy DEVICE

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

Study

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Batterjee Medical College: lead

Study Sites (1)

Batterjee Medical College

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Mohamed A. AbdelGhafar, Ph.D

  Batterjee Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 29, 2021
• Study Start: September 2, 2020
• Primary Completion: October 31, 2021
• Study Completion: November 13, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)