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OpenTrials
Completed

NCT Number: NCT05136716

Effect of Hyperbaric Oxygen Therapy on 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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Hyperbaric Oxygen Therapy Nervous System Diseases

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Batterjee Medical College

Jeddah, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

hyperbaric oxygen therapy

Device

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

Primary outcomes

  1. Velocity (cm/s)

    Time frame: 6 months

    Change of the velocity was measured using GAITRite System

  2. Stride Length (cm)

    Time frame: 6 months

    Change of the stride length was measured using GAITRite System

  3. Double leg support (% of gait cycle)

    Time frame: 6 months

    Change of the double leg support was measured using GAITRite System

  4. Functional Balance skills (score)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Batterjee Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 29, 2021
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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