Cerebral PalsyNCT05136716
Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy
A study testing Traditional Physical Therapy and Hyperbaric oxygen therapy in people with Cerebral Palsy and Hyperbaric Oxygen Therapy, run by Batterjee Medical College at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Cerebral Palsy, Hyperbaric Oxygen Therapy
- What is being tested?
- Traditional Physical Therapy and Hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Sep 2020to 13 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy, Hyperbaric Oxygen Therapy
- Being tested
- Traditional Physical Therapy, Hyperbaric oxygen therapy
- Keywords
- Spastic cerebral palsy, Hyperbaric oxygen therapy, Functional Balance, Gait parameters
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Physical TherapyOther
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 therapyDevice
HBO2 therapy at a pressure of 1.7 atm For 60 minutes, participants breathed 100% O2.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Children in this group received traditional physical therapy Receives: Other: Traditional Physical Therapy |
| Study | Experimental | Children in this group received the same traditional physical therapy plus hyperbaric oxygen therapy Receives: Device: Hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity (cm/s)
Change of the velocity was measured using GAITRite System
Measured: 6 months
Stride Length (cm)
Change of the stride length was measured using GAITRite System
Measured: 6 months
Double leg support (% of gait cycle)
Change of the double leg support was measured using GAITRite System
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start2 Sep 2020
- Primary completion31 Oct 2021
- Study completion13 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed A. Abdel Ghafar, Batterjee Medical College
- Investigators
- Mohamed A. AbdelGhafar, Ph.D, Principal investigator, Batterjee Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136716
- Sponsor's protocol ID
- Hyperbaric and Cerebral Palsy
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effect of Hyperbaric Oxygen Therapy on Gait and Functional Balance Skills in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05136716
- Acronym / sponsor ID
- Hyperbaric and Cerebral Palsy
- Conditions
- Cerebral Palsy, Hyperbaric Oxygen Therapy
- Keywords
- Spastic cerebral palsy, Hyperbaric oxygen therapy, Functional Balance, Gait parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 13 Nov 2021 (actual)
- First posted
- 29 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Traditional Physical TherapyChildren in this group received traditional physical therapy |
| Study | Experimental | Device: Hyperbaric oxygen therapyChildren in this group received the same traditional physical therapy plus hyperbaric oxygen therapy |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- Previous HBO treatments.
- botulinum toxin A treatments.
- thoracic surgery within 6 months.
- major changes to spasticity medications within 3 months.
- unstable epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Physical TherapyStretching for tight muscles, strengthening for weak muscles, postural reactions training, proprioceptive training, and walking training were all part of the neurodevelopmental treatment plan. | Other | Control |
| Hyperbaric oxygen therapyHBO2 therapy at a pressure of 1.7 atm For 60 minutes, participants breathed 100% O2. | Device | Study |
Primary outcome
Velocity (cm/s)
Time frame: 6 months
Change of the velocity was measured using GAITRite System
Stride Length (cm)
Time frame: 6 months
Change of the stride length was measured using GAITRite System
Double leg support (% of gait cycle)
Time frame: 6 months
Change of the double leg support was measured using GAITRite System
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A. AbdelGhafar, Ph.D principal investigator
Batterjee Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physical Therapy and Hyperbaric oxygen therapy in people with Cerebral Palsy and Hyperbaric Oxygen Therapy, run by Batterjee Medical College at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velocity (cm/s) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021; AzTrials last refreshed its copy on 6 Nov 2026.