- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05903508
Comparative Effect of Functional Task Training Versus Function Therapy Program
November 9, 2023 updated by: Riphah International University
Comparative Effect of Functional Task Training Versus Function Therapy Program on Gross Motor Function, Range of Motion and Balance in Children With Cerebral Palsy
cerebral palsy is the brain injury or brain malformation occur before, during and immediately after birth (while brain is still under development) and its effect muscle tone, reflexes, posture coordination gross and fine motor skill and oral motor functioning.
The functional training is the physiotherapist and occupational therapy rehabilitation technique focus on strength and function of musculoskeletal system and its help the patients to making their daily life activity easier.
The functional task training program consisted of non-walking (i-iii) and walking (iv-v) activities: (i) standing from a seated position; (ii) reaching for an object overhead, which required ankle plantar flexion from the standing position, and returning to the initial position with the heel leaning on the floor; (iii) stepping on and off a bench; (iv) walking up and down stairs; and (v) walking on flat surfaces and ramps.
Children with cerebral palsy frequently receive.
functional therapy programs the children participated in activities pertaining to everyday skills such as eating, playing, communication, and mobility.
To optimize the child's opportunities to practice towards the goals, parents and preschool staff were guided on efficiently encouraging the child.
Support and instructions from the professional to help them to develop better motor skills and increase independence in tasks like self-care, play, and recreational activities.so the study aimsto improve balance, gross motor function, and range of motion by using these functional training task and functional therapy program.
In my study compare the compare task training versus functional therapy programsm on gross motor function, range of motion on, and balance in cerebral palsy children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The randomized control trial will be conducted through convenient sampling.
There will be two group the experimental group will receive functional task training.
according to GMFS, Pediatric balance scale and goniometer to assess the gross motor function, ROM and balance in cerebral palsy, while control group will receive functional therapy program (bobath technique) to improve gross motor function, ROM and balance in cerebral palsy.
The duration of the treatment will be 8 weeks.
Gross motor function, pediatric balance scale, and goniometer will be used as outcome measure.
Data will be analyzed on spss version 29, normality of the data will be checked and test will be applied according to the normality of the data either in will be parametric test or nonparametric based on the normality
Study Type
Interventional
Enrollment (Actual)
12
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 Locations
-
-
Punjab
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Lahore, Punjab, Pakistan
- Riphah International University
-
-
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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both gender
- GMFCS (Gross Motor Function Classification System) score is in between 1-2,
- Ability to follow command
- Cerebral palsy diagnosed child (
- Age 6-12yr
Exclusion Criteria:
• Deformity like scoliosis. pelvic, oblique, and hip deformity
- Age more than 16
- Visual disorder
- Mental retardation
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Functional task training Group.
In this group patients will performed functional task training program was performed including non-walking (i-iii) and walking activities: (i) standing from a seated position; (ii) reaching for an object overhead, which required ankle plantar flexion from the standing position, and returning to the initial position with the heel leaning on the floor; (iii) stepping on and off a bench; (iv) walking up and down stairs; and (v) walking on flat surfaces and ramps.
for 8 weeks, 50 minutes per day, 3 times per week.
The individual session lasted approximately 10 minutes including the rest intervals.
|
Functional task training group this will receive walking and no walking activities
Functional therapy program Group this will receive goal directed training
|
|
Active Comparator: functional therapy program
In this group patients will performed functional therapy program as goal directed training to optimize the child to practice goal including stand when turning around between chair, cycles 5m on stationary bicyle on smooth surface, kicking a ball during 8 weeks, the children practiced a goal in 50 mintute per day and 3 times a week.
|
Functional task training group this will receive walking and no walking activities
Functional therapy program Group this will receive goal directed training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goniomete
Time Frame: 8 weeks
|
It will measure range of motion
|
8 weeks
|
|
Pediatric balance scale
Time Frame: 8 weeks
|
it is 14 items that measure the balance in the context of everyday task in pediatric population in 3 domain sitting standing and changing of position
|
8 weeks
|
|
Gross Motor Function Measure scale
Time Frame: 8 weeks
|
. The GMFM-88 item scores can be summed to calculate raw and percent scores for each of the five GMFM dimensions of interest selected goal areas and total GMFM-88 scores.
The scoring system of the GMFM is a four-point scale divided into five categories (lying and rolling; sitting; crawling and kneeling; standing; walking, running)
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: kinza Naeem, MS, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
May 23, 2023
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
September 15, 2023
Study Registration Dates
First Submitted
June 6, 2023
First Submitted That Met QC Criteria
June 6, 2023
First Posted (Actual)
June 15, 2023
Study Record Updates
Last Update Posted (Estimated)
November 13, 2023
Last Update Submitted That Met QC Criteria
November 9, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0703
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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