NCT04995952

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

August 6, 2021

Last Update Submit

June 22, 2023

Conditions

Cerebral Palsy

Keywords

Cerebral plasyTrunk targeted trainingGross motor trageted trainingBalance

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Goniometer

    This is an instrument which is used to measure the range of motion

    10 minutes

Study Arms (2)

Gross motor training activity

EXPERIMENTAL

Gross motor training activity It includes training of motor components of child grossly

Behavioral: Gross motor training

Trunk targeted training

EXPERIMENTAL

In this training group the particpiants were given the exercises that were focused the truck muscles

Behavioral: Trunk targeted training

Interventions

Gross motor trainingBEHAVIORAL

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

Gross motor training activity
Trunk targeted trainingBEHAVIORAL

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.

Trunk targeted training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • GMFCS III V
  • Age 8to12 years
  • Diplegic cerebral palsy
  • Hypoxic brain injury
  • Diagnosed with a gross motor delay by the pediatrician.

You may not qualify if:

  • Children having a cognitive or psychiatric disorder.
  • Children with known congenital limb anomaly
  • Children with some chromosomal defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Prof S Shakil Ur Rehman, Phd

    Riphah International University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
senior lecturer

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 9, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 15, 2021

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)