NCT05878756

Brief Summary

The randomized control trail was to determine the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

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, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

May 19, 2023

Last Update Submit

May 26, 2023

Conditions

Keywords

Cerebral palsyFunctional strength trainingMobilityGMFCGMFM

Outcome Measures

Primary Outcomes (2)

  • Gross Motor Function Measure (GMFM)

    GMFM is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy.

    Data was collected at Baseline and after 4 weeks

  • Gross Motor Function Classification System (GMFCS)

    The GMFCS, or Gross Motor Function Classification System, is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.

    Data was collected at Baseline and after 4 weeks

Secondary Outcomes (1)

  • Five time sit to stand (FTSST).

    Data was collected at Baseline and after 4 weeks

Study Arms (2)

Functional strength training

EXPERIMENTAL

With conventional therapy,the ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball preform from the patient 5 days per week for 4 weeks.

Other: Functional Strength Training

Conventional therapy

ACTIVE COMPARATOR

passive and active range of motion exercises,Stretching and strengthening exercise 5 days per week for 4 weeks.

Other: Functional Strength Training

Interventions

In addition to conventional therapy, experimental group was also given functional strength training program. Functional strength training was given as home program consisting of ten tasks.The ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball.

Also known as: conventional therapy
Conventional therapyFunctional strength training

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children who didnot use the assistive device children who follow the commands children who did not treated in any other rehabilitation center

You may not qualify if:

  • children with any other diagnosis other than CP children with fixed contractures children underwent surgery children who received Botulinum Toxin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yusra Institute of Rehablitation Science

Islamabad, 45400, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mamoona Tasleem Afzal

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 26, 2023

Study Start

January 1, 2020

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations