Back to resultsEffects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy
Primary Purpose
Hemiplegic Cerebral Palsy, Mobility
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Functional Strength Training
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Cerebral palsy, Functional strength training, Mobility, GMFC, GMFM
Eligibility Criteria
Inclusion Criteria: children who didnot use the assistive device children who follow the commands children who did not treated in any other rehabilitation center Exclusion Criteria: children with any other diagnosis other than CP children with fixed contractures children underwent surgery children who received Botulinum Toxin
Sites / Locations
- Yusra Institute of Rehablitation Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Functional strength training
Conventional therapy
Arm Description
With conventional therapy,the ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball preform from the patient 5 days per week for 4 weeks.
passive and active range of motion exercises,Stretching and strengthening exercise 5 days per week for 4 weeks.
Outcomes
Primary Outcome Measures
Gross Motor Function Measure (GMFM)
GMFM is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy.
Gross Motor Function Classification System (GMFCS)
The GMFCS, or Gross Motor Function Classification System, is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.
Secondary Outcome Measures
Five time sit to stand (FTSST).
Used to asses functional lower extremity strength, transitional movements, balance, and fall risk
Full Information
NCT ID
NCT05878756
First Posted
May 19, 2023
Last Updated
May 26, 2023
Sponsor
Health Education Research Foundation (HERF)
1. Study Identification
Unique Protocol Identification Number
NCT05878756
Brief Title
Effects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy
Official Title
Effects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy,A Randomized Control Trail
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Education Research Foundation (HERF)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The randomized control trail was to determine the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy.
Detailed Description
The aim of functional physiotherapy is to train the child by emphasizing him to learn motor abilities. These motor abilities are those that are thought to be though either by children with cerebral palsy or their parents. Functional activities are learned by the repetitive practice of goal-oriented tasks in a given functional situation. This approach instead of focusing on normality, it focuses on functionality. In this way, it is very necessary for the child to practice a given task functionally rather than normally.No studies have been done to improve mobility and strength in lower limb in children with hemiplegia cerebral palsy. So for this reason, this study is conducted to investigate the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy.In this way we can make these children an active participant of the society.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy, Mobility
Keywords
Cerebral palsy, Functional strength training, Mobility, GMFC, GMFM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional strength training
Arm Type
Experimental
Arm Description
With conventional therapy,the ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball preform from the patient 5 days per week for 4 weeks.
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
passive and active range of motion exercises,Stretching and strengthening exercise 5 days per week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Functional Strength Training
Other Intervention Name(s)
conventional therapy
Intervention Description
In addition to conventional therapy, experimental group was also given functional strength training program. Functional strength training was given as home program consisting of ten tasks.The ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure (GMFM)
Description
GMFM is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy.
Time Frame
Data was collected at Baseline and after 4 weeks
Title
Gross Motor Function Classification System (GMFCS)
Description
The GMFCS, or Gross Motor Function Classification System, is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.
Time Frame
Data was collected at Baseline and after 4 weeks
Secondary Outcome Measure Information:
Title
Five time sit to stand (FTSST).
Description
Used to asses functional lower extremity strength, transitional movements, balance, and fall risk
Time Frame
Data was collected at Baseline and after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children who didnot use the assistive device children who follow the commands children who did not treated in any other rehabilitation center
Exclusion Criteria:
children with any other diagnosis other than CP children with fixed contractures children underwent surgery children who received Botulinum Toxin
Facility Information:
Facility Name
Yusra Institute of Rehablitation Science
City
Islamabad
ZIP/Postal Code
45400
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy
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