NCT05903508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

June 6, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

gross motor function, cerebral palsy

Outcome Measures

Primary Outcomes (3)

  • Goniomete

    It will measure range of motion

    8 weeks

  • 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

  • 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

Study Arms (2)

Functional task training Group.

ACTIVE COMPARATOR

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.

Other: Functional task training and functional therapy programOther: Functional therapy program Group

functional therapy program

ACTIVE COMPARATOR

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.

Other: Functional task training and functional therapy programOther: Functional therapy program Group

Interventions

Functional task training group this will receive walking and no walking activities

Functional task training Group.functional therapy program

Functional therapy program Group this will receive goal directed training

Functional task training Group.functional therapy program

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Deformity like scoliosis. pelvic, oblique, and hip deformity
  • Age more than 16
  • Visual disorder
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related 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.

    PMID: 31649770BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • kinza Naeem, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will get seperate treatment protocol and possible efforts will be put to mask the both groups about thier treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

May 23, 2023

Primary Completion

August 31, 2023

Study Completion

September 15, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations