Clinical trial NCT05136716: Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy
Official title: Long Term Effect of Hyperbaric Oxygen Therapy on Gait and Functional Balance Skills in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Hyperbaric Oxygen Therapy
Keywords: Spastic cerebral palsy
Hyperbaric oxygen therapy
Functional Balance
Gait parameters
Lead sponsor: Batterjee Medical College
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 39
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Velocity (cm/s)
timeFrame: 6 months
measure: Stride Length (cm)
timeFrame: 6 months
measure: Double leg support (% of gait cycle)
timeFrame: 6 months
measure: Functional Balance skills (score)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Batterjee Medical College
Study officials:
affiliation: Batterjee Medical College
name: Mohamed A. AbdelGhafar, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: