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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05903508
Other study ID # REC/RCR&AHS/23/0703
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2023
Est. completion date September 15, 2023

Study information

Verified date November 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 15, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Functional task training and functional therapy program
Functional task training group this will receive walking and no walking activities
Functional therapy program Group
Functional therapy program Group this will receive goal directed training

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Goniomete It will measure range of motion 8 weeks
Primary 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 8 weeks
Primary 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) 8 weeks
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