Effectiveness of Routine Physical Therapy With Intensive Bimanual Training in Cerebral Palsy Children

February 10, 2021 updated by: University of Lahore

Effectiveness of Routine Physical Therapy With or Without Home Based Intensive Bimanual Training on Clinical Outcomes in Cerebral Palsy Children: A Randomized Controlled Trial

Effectiveness of Routine Physical Therapy With or Without Home Based Intensive Bimanual Training on Clinical Outcomes in Cerebral Palsy Children

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cerebral Palsy is one of the most common issue seen in pediatric rehabilitation .Home based intensive Bimanual training has proven to be one of the most effective rehabilitation training for improving motor. The study determines the effectiveness of routine physical therapy with or without home-based intensive bimanual training on coordination of hands and daily activities of daily living. A nine months randomized control trial was comprised of thirty children with unilateral spastic cerebral palsy aged between 4 to 7 years. One group received routine physical therapy and the other group received a goal specific bimanual training from their parents in their home setting for 3.5 hours per week for 6 weeks according to a modified set up. Follow up sessions were done at 6th week. Activities of daily living and coordination were measured using Pediatric motor log activity scale and ABILHAND respectively.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • University of Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Spastic CP children

    • Both male and female
    • Age 4-7 years
    • Actively grasp of objects from table i.e., stuff toys, making blocks
    • One to one attention

Exclusion Criteria:

  • Cognitive delays preventing the child from following two-step instructions

    • Health diagnoses unassociated with USCP.
    • Parents unable to commit to entire duration of intervention.
    • Visual difficulties preventing performance of intervention tasks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Experimental group
Intensive bimanual training with routine physical therapy
Other: home based intensive bimanual training
Home Based Intensive Bimanual Training with Routine Physical Therapy bimanual training includes. functional activities play with ball, make a dough, make beads, make blocks .Routine Physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.
Other: control group
routine physical therapy
Other: Routine Physical Therapy
Routine physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABILHAND
Time Frame: 6th week
hand coordination
6th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Motor Log Activity Scale
Time Frame: 6th week
Activity of Daily Living
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Fatima Ejaz, MS-PT, University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2020

Primary Completion (Actual)

December 6, 2020

Study Completion (Actual)

December 6, 2020

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-UOL-FAHS/718-XI/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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