Hemiplegic Cerebral PalsyNCT05787977
The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Cerebral Palsy
A study testing Visual Feedback and Rhythmic Auditory Cue in people with Hemiplegic Cerebral Palsy, run by Sehat Medical Complex at 1 site in Pakistan.
Trial summary
The development of efficient and independent walking is an important therapeutic goal for many children with cerebral palsy (CP). Consequently, there has been growing interest in determining the effects of treadmill training programs for these children. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Visual Feedback and Rhythmic Auditory Cue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Dec 2022to 22 Mar 2024
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children having GMF level 1 and 2,
- willing to participate,
- Pediatric subjects Diagnosed with cerebral palsy, receiving Neurodevelopmental
- Rehabilitation program regularly.
Who cannot join
- Child using any sort of auditory aid
- Children with visual limitation,
- Child using orthosis for lower extremity
Trial locations and contacts
1 site in 1 country.
About this study
The development of efficient and independent walking is an important therapeutic goal for many children with cerebral palsy (CP). Consequently, there has been growing interest in determining the effects of treadmill training programs for these children.
This study helped to investigates the effect of treadmill training with visual feedback and rhythmic auditory cue (VF+RAC) for walking symmetry and balance ability. Participants were chosen from Sehat medical complex and they were randomly allocated to either the VF+RAC or the Control group. The VF+RAC group received treadmill training with VF and RAC, and the Control group undergo treadmill training without any visual and auditory stimulation. VF+RAC and Control groups was trained five times per week for eight weeks. After eight weeks of training the gait pattern and balance were evaluated by the gait parameters, 6min Walk test, Pediatric Balance Scale and Berg balance scale.
Read the detailed description
Cerebral palsy is the most common cause of childhood-onset, lifelong physical disability in most countries, affecting about 1 in 500 neonates with an estimated prevalence of 17 million people worldwide. Cerebral palsy is a non-progressive brain injury or lesion acquired during the antenatal, perinatal or early postnatal period. The clinical manifestations of cerebral palsy vary greatly in the type of movement disorder, the degree of functional ability and limitation and the affected parts of the body.
Auditory entrainment can influence gait performance in movement disorders. The entrainment can incite neurophysiological and musculoskeletal changes to enhance motor execution. Biofeedback systems have been extensively used in walking exercises for gait improvement.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Visual Feedback and Rhythmic Auditory Cue
- Keywords
- Treadmill training, Visual Feedback and Rhythmic Auditory cue, Gait and Balance, Hemiplegic Cerebral palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Feedback and Rhythmic Auditory CueOther
Patients were trained five times per week for eight weeks. After eight weeks of training the gait pattern and balance was evaluated by the gait parameters, 6min Walk test, Pediatric Balance Scale and Berg balance scale.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Treadmil Training with visual feedback and rhythmic Auditory Cue Receives: Other: Visual Feedback and Rhythmic Auditory Cue |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes Walk Test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Change from baseline at 8th week
Pediatric Balance scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: Change from baseline at 8th Week
Berg Balance Scale
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Measured: Change from baseline at 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start20 Dec 2022
- Primary completion22 Feb 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic 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
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehat Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Momina Mehmood, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787977
- Sponsor's protocol ID
- Asma001-04
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05787977
- Acronym / sponsor ID
- Asma001-04
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Treadmill training, Visual Feedback and Rhythmic Auditory cue, Gait and Balance, Hemiplegic Cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sehat Medical ComplexUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 28 Mar 2023 (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.
The development of efficient and independent walking is an important therapeutic goal for many children with cerebral palsy (CP). Consequently, there has been growing interest in determining the effects of treadmill training programs for these children.
This study helped to investigates the effect of treadmill training with visual feedback and rhythmic auditory cue (VF+RAC) for walking symmetry and balance ability. Participants were chosen from Sehat medical complex and they were randomly allocated to either the VF+RAC or the Control group. The VF+RAC group received treadmill training with VF and RAC, and the Control group undergo treadmill training without any visual and auditory stimulation. VF+RAC and Control groups was trained five times per week for eight weeks. After eight weeks of training the gait pattern and balance were evaluated by the gait parameters, 6min Walk test, Pediatric Balance Scale and Berg balance scale.
Detailed description
Cerebral palsy is the most common cause of childhood-onset, lifelong physical disability in most countries, affecting about 1 in 500 neonates with an estimated prevalence of 17 million people worldwide. Cerebral palsy is a non-progressive brain injury or lesion acquired during the antenatal, perinatal or early postnatal period. The clinical manifestations of cerebral palsy vary greatly in the type of movement disorder, the degree of functional ability and limitation and the affected parts of the body.
Auditory entrainment can influence gait performance in movement disorders. The entrainment can incite neurophysiological and musculoskeletal changes to enhance motor execution. Biofeedback systems have been extensively used in walking exercises for gait improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Visual Feedback and Rhythmic Auditory CueTreadmil Training with visual feedback and rhythmic Auditory Cue |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children having GMF level 1 and 2,
- willing to participate,
- Pediatric subjects Diagnosed with cerebral palsy, receiving Neurodevelopmental
- Rehabilitation program regularly.
Key exclusion criteria (3 listed)
- Child using any sort of auditory aid
- Children with visual limitation,
- Child using orthosis for lower extremity
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 |
|---|---|---|
| Visual Feedback and Rhythmic Auditory CuePatients were trained five times per week for eight weeks. After eight weeks of training the gait pattern and balance was evaluated by the gait parameters, 6min Walk test, Pediatric Balance Scale and Berg balance scale. | Other | Interventional Group |
Primary outcome
6 Minutes Walk Test
Time frame: Change from baseline at 8th week
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Pediatric Balance scale
Time frame: Change from baseline at 8th Week
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Berg Balance Scale
Time frame: Change from baseline at 8th week
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
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 Mar 2024.
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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.
Momina Mehmood principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Feedback and Rhythmic Auditory Cue in people with Hemiplegic Cerebral Palsy, run by Sehat Medical Complex at 1 site in Pakistan.
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 4 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 Mar 2024. 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 Pakistan. 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?
6 Minutes Walk Test (time frame: Change from baseline at 8th week). The study lists 3 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 Mar 2024.