- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770778
Comparison of Inclined Backwalk vs Kneel Walk on Genurecurvatum in Hemiplegic Cerebral Palsy
March 14, 2023 updated by: Waseem Javaid, Sehat Medical Complex
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Imran Ghafoor
- Phone Number: 03344292887
- Email: imran.ghafoor64@gamil.com
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 55201
- Recruiting
- Sehat Medical Complex, Lahore
-
Contact:
- Waseem Javaid
- Phone Number: 04235410037
- Email: info.hw@smc.uol.edu.pk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- GMFM level (I & II)
- knee hyperextension ranged from 10 to 20 degrees
Exclusion Criteria:
- Children with comorbidities (other knee deformities, surgical intervention or fractures) will not included in this study.
- Children who recently have botulinum toxin injection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Inclined Backward Intervention Group
Hemiplegic Cerebral Palsy Children
|
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.
|
|
Active Comparator: Kneel Walk Intervention Group
Hemiplegic Cerebral Palsy Children
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion
Time Frame: Change from baseline at 3rd Month
|
The limit or length ranges of each plane of the joint
|
Change from baseline at 3rd Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Momina Mehmood, University of Lahore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2023
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
July 1, 2023
Study Registration Dates
First Submitted
February 24, 2023
First Submitted That Met QC Criteria
March 14, 2023
First Posted (Actual)
March 15, 2023
Study Record Updates
Last Update Posted (Actual)
March 15, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laraib001-25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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