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Comparative Effect of Functional Task Training Versus Function Therapy Program

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Functional task training and functional therapy program
Functional therapy program Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring gross motor function, cerebral palsy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Functional task training Group.

functional therapy program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Goniomete
It will measure range of motion
Pediatric balance scale
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
Gross Motor Function Measure scale
. 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)

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
July 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05903508
Brief Title
Comparative Effect of Functional Task Training Versus Function Therapy Program
Official Title
Comparative Effect of Functional Task Training Versus Function Therapy Program on Gross Motor Function, Range of Motion and Balance in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
gross motor function, cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Its a randomized control trial,used to evaluate the comparative affect of functional task training versus functional therapy programsm on gross motor function, range of motion on, and balance in cerebral palsy children.Subject with hemiplagic Cerebral palsy (GMFCS level 1-11) meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique
Masking
Participant
Masking Description
Participant will get seperate treatment protocol and possible efforts will be put to mask the both groups about thier treatment
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional task training Group.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
functional therapy program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Functional task training and functional therapy program
Intervention Description
Functional task training group this will receive walking and no walking activities
Intervention Type
Other
Intervention Name(s)
Functional therapy program Group
Intervention Description
Functional therapy program Group this will receive goal directed training
Primary Outcome Measure Information:
Title
Goniomete
Description
It will measure range of motion
Time Frame
8 weeks
Title
Pediatric balance scale
Description
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
Time Frame
8 weeks
Title
Gross Motor Function Measure scale
Description
. 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)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
+9233224390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Asif Javed, MS
Phone
+923224209422
Email
a.javed@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kinza Naeem, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31649770
Citation
Sah AK, Balaji GK, Agrahara S. Effects of Task-oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control, Balance, and Gross Motor Function in Children with Spastic Diplegic Cerebral Palsy: A Single-blinded Randomized Clinical Trial. J Pediatr Neurosci. 2019 Jul-Sep;14(3):120-126. doi: 10.4103/jpn.JPN_35_19. Epub 2019 Sep 27.
Results Reference
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Comparative Effect of Functional Task Training Versus Function Therapy Program

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