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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04995952
Other study ID # RiphahIU maryam
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date July 15, 2021

Study information

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

Clinical Trial Summary

In this study trunk, targeted training and gross motor function training were compared their effect on functional status, range of motion, and community participation of cerebral palsy children


Description:

In this project a randomized clinical trial was be conducted to determine the comparison of gross motor training technique and trunk training therapy on balance, Range of motion and community participation in children with diplegic cerebral palsy. This study aim to compare the effects of both the treatments to improve balance, quality of life and community participation. The sample was being collected according to inclusion and exclusion criteria using a convenient sampling technique within period of 6 months. The participants were be randomly allocated in two groups' .Group A received gross motor training which included sit to stand, step up and walking for 1 hour/day/3 days a week for 3 months. Group B received trunk targeted training for 1 hour/day/3 days a week for 3 months which included treadmill walking, reaching forward to the limits of stability and specific truncal activities with vibration and proprioception. The post treatment assessments was done via early assessment of balance, goniometer, and functional mobility assessment


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 15, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria male & female. - GMFCS III V - Age 8to12 years - Diplegic cerebral palsy - Hypoxic brain injury - Diagnosed with a gross motor delay by the pediatrician. Exclusion Criteria: - Children having a cognitive or psychiatric disorder. - Children with known congenital limb anomaly - Children with some chromosomal defect

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Gross motor training
Gross motor training activity (1 hour session, 3 times a week for 3 months). Pre ad post assessments will be taken. The Gross motor training activity will include: sit to stand, step-ups and walking. The sit to stand will be performed for 20 minutes involving 20 repetitions. We will progress from high seat sit to stand to low seat sit to stand. The step up will progress initially from a bench having low height to high height and then to stepping of stairs for 20 minutes involving 30 repetitions. The walking will occur from 3m walk and then increasing the distance
Trunk targeted training
Trunk targeted training (1hour session, 3 times a week for 3 months). Pre and Post assessment will be evaluated. The trunk targeted training will include: weight supported treadmill walk, specific trunk exercises with vibration therapy and reaching forward to the limits of stability. Specific trunk exercises will involve stride sitting to standing, sitting on a roll and moving the roll in diagonal and forward backward directions along with giving vibrational therapy on wobble board, side sitting. This activity will be performed for 30 minutes with 30 repetitions. Reaching forward to the limits of stability exercises will be performed. Asking the children to hold objects from right hand while reaching for an object on left side and vice versa. This will be performed for 20 minutes having 20 repetitions.

Locations

Country Name City State
Pakistan Riphah Rehabilitation Center Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
khadija liaquat

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional mobility assessment It classifies the functional mobility of children between ages 4-18 years of age with cerebral palsy. The scale can be used to classify children's functional mobility, document change over time in the same child and to document change. The FMS rates walking ability at three specific distances, 5, 50 and 500 meters, (or 5, 50, 500 yards). This represents the child's mobility in the home, at school and in the community setting 10 minutes
Primary Pediatric Berg Balance Scale The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children and children with cerebral palsy. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. 20 minutes
Primary Goniometer This is an instrument which is used to measure the range of motion 10 minutes
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