Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136716
• Other study ID #: Hyperbaric and Cerebral Palsy
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: November 13, 2021

Study information

• Verified date: November 2021
• Source: Batterjee Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 13, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hyperbaric Oxygen Therapy
• Paralysis

Intervention

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.

Device:
• Hyperbaric oxygen therapy
HBO2 therapy at a pressure of 1.7 atm For 60 minutes, participants breathed 100% O2.

Locations

Country	Name	City	State
Saudi Arabia	Batterjee Medical College	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
Batterjee Medical College

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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