Hemiplegic Cerebral PalsyNCT05770778
Comparison of Inclined Backwalk vs Kneel Walk on Genurecurvatum in Hemiplegic Cerebral Palsy
A study testing Inclined Backwalk and Knee Walk in people with Hemiplegic Cerebral Palsy, run by Sehat Medical Complex at 1 site in Pakistan.
Trial summary
The 40-68% of ambulating hemiplegic children walk with genu recurvatum and hemiplegic patients shows excessive anterior pelvic tilts (>4 cm) during the stance phase. The objective of the study is to compare the effects of inclined backward treadmill walk vs kneel walk on genu recurvatum in hemiplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Inclined Backwalk and Knee Walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Feb 2023to Jul 2023
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GMFM level (I \& II)
- knee hyperextension ranged from 10 to 20 degrees
Who cannot join
- Children with comorbidities (other knee deformities, surgical intervention or fractures) will not included in this study.
- Children who recently have botulinum toxin injection.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Sehat Medical Complex, Lahore
Lahore, Punjab Province, 55201
Waseem Javaid, 04235410037, info.hw@smc.uol.edu.pk
About this study
The 40-68% of ambulating hemiplegic children walk with genu recurvatum and hemiplegic patients shows excessive anterior pelvic tilts (>4 cm) during the stance phase. The objective of the study is to compare the effects of inclined backward treadmill walk vs kneel walk on genu recurvatum in hemiplegic cerebral palsy. 50 participants will be chosen according to inclusion exclusion criteria of the study which will be randomly allocated into two equal groups . One group will receive treadmill training programme with specifically designed physical therapy program according to child need for one hour for each child. And other group will receive kneel walking programme specifically designed physical therapy program according to child need for one hour for each child. The pre and post assessment of genurecurvatum will be assessed by Goniometer.
Read the detailed description
Efficiency of walking and the development of independent gait are often the focus of therapeutic interventions for children with CP. Motor learning theory suggests that when encountering a new motor skill or adapting a motor skill to a specific situation, a group of interconnected neurons is selected from a primary neuronal repertoire based on prior experience of the task. Generated movement patterns and postural adjustments are then refined via afferent feedback. Therefore, it has been argued that to develop and improve a motor skill such as walking, opportunities for repetitive practice of the skill need to be offered. For this reason use of a mechanical treadmill may improve walking in children with CP. Treadmill walking provides increased opportunity to repetitively train the whole gait cycle, facilitate an improved gait pattern. Improved walking has the potential to increase the mobility and positively influence the societal participation of children with CP at home, at school and in the wider community.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Inclined Backwalk, Knee Walk
- Keywords
- Hemiplegic Cerebral Palsy, Genu-Recurvatum, Inclined Backward Walk, Kneel walk., Treadmill training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclined BackwalkOther
They will receive inclined backward treadmill gait training exercise for thirty minutes with 2 interval break for 5min every 10 minutes for three times per week over three successive months with a specifically designed physical therapy program according to child need for one hour for each child, three times weekly, over three months.
Knee WalkOther
They will receive kneel walk exercise programme for thirty minutes with 2 interval break for 5min every 10 minutes for three times per week over three successive months with a specifically designed physical therapy program according to child need for one hour for each child , three times weekly, over three months.
| Study group | Role | What they receive |
|---|---|---|
| Inclined Backward Intervention Group | Active comparator | Hemiplegic Cerebral Palsy Children Receives: Other: Inclined Backwalk |
| Kneel Walk Intervention Group | Active comparator | Hemiplegic Cerebral Palsy Children Receives: Other: Knee Walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
The limit or length ranges of each plane of the joint
Measured: Change from baseline at 3rd Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start3 Feb 2023
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehat Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waseem Javaid, Sehat Medical Complex
- Investigators
- Momina Mehmood, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770778
- Sponsor's protocol ID
- Laraib001-25
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inclined Backwalk vs Kneel Walk on Genurecurvatum in Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05770778
- Acronym / sponsor ID
- Laraib001-25
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Hemiplegic Cerebral Palsy, Genu-Recurvatum, Inclined Backward Walk, Kneel walk., Treadmill training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sehat Medical ComplexUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 15 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 40-68% of ambulating hemiplegic children walk with genu recurvatum and hemiplegic patients shows excessive anterior pelvic tilts (>4 cm) during the stance phase. The objective of the study is to compare the effects of inclined backward treadmill walk vs kneel walk on genu recurvatum in hemiplegic cerebral palsy. 50 participants will be chosen according to inclusion exclusion criteria of the study which will be randomly allocated into two equal groups . One group will receive treadmill training programme with specifically designed physical therapy program according to child need for one hour for each child. And other group will receive kneel walking programme specifically designed physical therapy program according to child need for one hour for each child. The pre and post assessment of genurecurvatum will be assessed by Goniometer.
Detailed description
Efficiency of walking and the development of independent gait are often the focus of therapeutic interventions for children with CP. Motor learning theory suggests that when encountering a new motor skill or adapting a motor skill to a specific situation, a group of interconnected neurons is selected from a primary neuronal repertoire based on prior experience of the task. Generated movement patterns and postural adjustments are then refined via afferent feedback. Therefore, it has been argued that to develop and improve a motor skill such as walking, opportunities for repetitive practice of the skill need to be offered. For this reason use of a mechanical treadmill may improve walking in children with CP. Treadmill walking provides increased opportunity to repetitively train the whole gait cycle, facilitate an improved gait pattern. Improved walking has the potential to increase the mobility and positively influence the societal participation of children with CP at home, at school and in the wider community.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inclined Backward Intervention Group | Active comparator | Other: Inclined BackwalkHemiplegic Cerebral Palsy Children |
| Kneel Walk Intervention Group | Active comparator | Other: Knee WalkHemiplegic Cerebral Palsy Children |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- GMFM level (I \& II)
- knee hyperextension ranged from 10 to 20 degrees
Key exclusion criteria (2 listed)
- Children with comorbidities (other knee deformities, surgical intervention or fractures) will not included in this study.
- Children who recently have botulinum toxin injection.
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 |
|---|---|---|
| Inclined BackwalkThey will receive inclined backward treadmill gait training exercise for thirty minutes with 2 interval break for 5min every 10 minutes for three times per week over three successive months with a specifically designed physical therapy program according to child need for one hour for each child, three times weekly, over three months. | Other | Inclined Backward Intervention Group |
| Knee WalkThey will receive kneel walk exercise programme for thirty minutes with 2 interval break for 5min every 10 minutes for three times per week over three successive months with a specifically designed physical therapy program according to child need for one hour for each child , three times weekly, over three months. | Other | Kneel Walk Intervention Group |
Primary outcome
Range of Motion
Time frame: Change from baseline at 3rd Month
The limit or length ranges of each plane of the joint
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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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 Inclined Backwalk and Knee Walk 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Ghafoor (03344292887, imran.ghafoor64@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: Change from baseline at 3rd Month). 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 15 Mar 2023.