Comparison of Inclined Backwalk vs Kneel Walk on Genurecurvatum in Hemiplegic Cerebral Palsy
Primary Purpose
Hemiplegic Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Inclined Backwalk
Knee Walk
Sponsored by
About this trial
This is an interventional other trial for Hemiplegic Cerebral Palsy focused on measuring Hemiplegic Cerebral Palsy, Genu-Recurvatum, Inclined Backward Walk, Kneel walk., Treadmill training
Eligibility Criteria
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.
Sites / Locations
- Sehat Medical Complex, LahoreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Inclined Backward Intervention Group
Kneel Walk Intervention Group
Arm Description
Hemiplegic Cerebral Palsy Children
Hemiplegic Cerebral Palsy Children
Outcomes
Primary Outcome Measures
Range of Motion
The limit or length ranges of each plane of the joint
Secondary Outcome Measures
Full Information
NCT ID
NCT05770778
First Posted
February 24, 2023
Last Updated
March 14, 2023
Sponsor
Sehat Medical Complex
1. Study Identification
Unique Protocol Identification Number
NCT05770778
Brief Title
Comparison of Inclined Backwalk vs Kneel Walk on Genurecurvatum in Hemiplegic Cerebral Palsy
Official Title
Comparison of Inclined Backwalk vs Kneel Walk on Genurecurvatum in Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sehat Medical Complex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
Hemiplegic Cerebral Palsy, Genu-Recurvatum, Inclined Backward Walk, Kneel walk., Treadmill training
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inclined Backward Intervention Group
Arm Type
Active Comparator
Arm Description
Hemiplegic Cerebral Palsy Children
Arm Title
Kneel Walk Intervention Group
Arm Type
Active Comparator
Arm Description
Hemiplegic Cerebral Palsy Children
Intervention Type
Other
Intervention Name(s)
Inclined Backwalk
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Knee Walk
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of Motion
Description
The limit or length ranges of each plane of the joint
Time Frame
Change from baseline at 3rd Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Ghafoor
Phone
03344292887
Email
imran.ghafoor64@gamil.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momina Mehmood
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sehat Medical Complex, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
55201
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waseem Javaid
Phone
04235410037
Email
info.hw@smc.uol.edu.pk
12. IPD Sharing Statement
Learn more about this trial
Comparison of Inclined Backwalk vs Kneel Walk on Genurecurvatum in Hemiplegic Cerebral Palsy
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