Vestibular RehabilitationNCT04246658
Effect of Platform Swing Walkway on Locomotor Behavior in Diplegic Children
A study testing conventional physical therapy program and gait training on platform swing walkway in people with Vestibular Rehabilitation, run by hanaa mohsen at 1 site in Egypt.
Trial summary
Locomotor activity is accompanied by a number of sensory stimuli: visual, auditory, olfactory, vestibular, and somatosensory. When improving motor skills, incorporating postural reflexes, creating synchronized eye movements, and visual attention skills, the vestibular system is particularly important. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Vestibular Rehabilitation
- What is being tested?
- conventional physical therapy program and gait training on platform swing walkway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 31 Jan 2020
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- were cognitively competent
- able to understand and follow instructions.
Who cannot join
- if they had fixed contractures
- deformities of the spine, upper or lower extremities,
- visual or respiratory disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Platform Swing Walkway on Locomotor Behavior in Children With Diaplegia
Locomotor activity is accompanied by a number of sensory stimuli: visual, auditory, olfactory, vestibular, and somatosensory. When improving motor skills, incorporating postural reflexes, creating synchronized eye movements, and visual attention skills, the vestibular system is particularly important.
Read the detailed description
Thirty diaplegic cerebral palsied children of both sexes, ranged in age from 3 to 6 years enrolled in this study. They randomly assigned into two groups of equal number; control group (A), study group (B). Group (A) groups received the conventional physical therapy program based on neurodevelopmental approach for such cases. Whereas study group (B) received the same conventional physical therapy program given to group (A) in addition to gait training on platform swing walkway for 30 minute. All children were assessed before and after the treatment program by using 2D video based gait assessment system to measure the percentage of swing and stance phase, also GMFM was used to assess standing and walking, running, and jumping abilities, domains (D) and (E).
- Conditions
- Vestibular Rehabilitation
- Being tested
- conventional physical therapy program, gait training on platform swing walkway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapy programOther
traditional physical therapy program
gait training on platform swing walkwayOther
gait training on platform swing walkway for 30 minute.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | gait training on platform swing walkway for 30 minute. Receives: Other: conventional physical therapy program; Other: gait training on platform swing walkway |
| control group | Experimental | conventional physical therapy program Receives: Other: conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Motor Function Measure Scale (GMFM).
Growth Motor Function Measure Scaleis the scale tat will assess the functional gross preinterventiona and after 3 months of the treatment program
Measured: pre intervension and after three months of the intervention to asses the improvent in standing and walking .the highest score indicate improvementg
2D, video based gait assessment system:
Tracker Video Analysis and Modeling Tool
Measured: 2D, video based gait assessment system asses the change in the stance in swing phase before and after three months of the intervention program .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Sep 2019
- Primary completion27 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular RehabilitationStudies 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- hanaa mohsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hanaa mohsen, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246658
- Sponsor's protocol ID
- Hana1
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platform Swing Walkway on Locomotor Behavior in Children With Diaplegia
- ClinicalTrials.gov ID
- NCT04246658
- Acronym / sponsor ID
- Hana1
- Conditions
- Vestibular Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- hanaa mohsenUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 29 Jan 2020 (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.
Locomotor activity is accompanied by a number of sensory stimuli: visual, auditory, olfactory, vestibular, and somatosensory. When improving motor skills, incorporating postural reflexes, creating synchronized eye movements, and visual attention skills, the vestibular system is particularly important.
Detailed description
Thirty diaplegic cerebral palsied children of both sexes, ranged in age from 3 to 6 years enrolled in this study. They randomly assigned into two groups of equal number; control group (A), study group (B). Group (A) groups received the conventional physical therapy program based on neurodevelopmental approach for such cases. Whereas study group (B) received the same conventional physical therapy program given to group (A) in addition to gait training on platform swing walkway for 30 minute. All children were assessed before and after the treatment program by using 2D video based gait assessment system to measure the percentage of swing and stance phase, also GMFM was used to assess standing and walking, running, and jumping abilities, domains (D) and (E).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: conventional physical therapy program, Other: gait training on platform swing walkwaygait training on platform swing walkway for 30 minute. |
| control group | Experimental | Other: conventional physical therapy programconventional physical therapy program |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- were cognitively competent
- able to understand and follow instructions.
Key exclusion criteria (3 listed)
- if they had fixed contractures
- deformities of the spine, upper or lower extremities,
- visual or respiratory disorders.
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 |
|---|---|---|
| conventional physical therapy programtraditional physical therapy program | Other | Treatment group, control group |
| gait training on platform swing walkwaygait training on platform swing walkway for 30 minute. | Other | Treatment group |
Primary outcome
Growth Motor Function Measure Scale (GMFM).
Time frame: pre intervension and after three months of the intervention to asses the improvent in standing and walking .the highest score indicate improvementg
Growth Motor Function Measure Scaleis the scale tat will assess the functional gross preinterventiona and after 3 months of the treatment program
2D, video based gait assessment system:
Time frame: 2D, video based gait assessment system asses the change in the stance in swing phase before and after three months of the intervention program .
Tracker Video Analysis and Modeling Tool
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 26 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy program and gait training on platform swing walkway in people with Vestibular Rehabilitation, run by hanaa mohsen at 1 site in Egypt.
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 2 inclusion and 3 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 26 Jan 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 Egypt. 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?
Growth Motor Function Measure Scale (GMFM). (time frame: pre intervension and after three months of the intervention to asses the improvent in standing and walking .the highest score indicate improvementg). The study lists 2 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 26 Jan 2021.