Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy

February 4, 2022 updated by: walaa eldesoukey heneidy, Delta University for Science and Technology
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

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 Contact

Study Contact Backup

Study Locations

    • Dakahelia
      • Gamasa, Dakahelia, Egypt, 4030
        • Recruiting
        • Delta University for Science and Technology
        • Contact:

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

7 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ataxic cerebral palsy aged 7-13 years

Exclusion Criteria:

  • any musculoskeletal conditions that affect balance previous surgeries that affecting balance

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
Experimental: traditional physical therapy group
received traditional physical therapy protocol
traditional physical therapy group
Experimental: lower extremity weights group
received the same traditional physical therapy in addition to lower extremity weights
traditional physical therapy group
All children in the two groups received physical therapy protocol for 30 minutes in addition to half kg of sandbags weights attached for each leg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in overall stability index
Time Frame: baseline and after 3 months of intervention.
change in overall stability index will measured by using biodex balance system
baseline and after 3 months of intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antero-posterior stability index
Time Frame: baseline and after 3 months of intervention.
change in antero-posterior stability index will measured by using biodex balance system
baseline and after 3 months of intervention.
mediolateral stability index
Time Frame: baseline and after 3 months of intervention.
change in mediolateral stability index will measured by using biodex balance system
baseline and after 3 months of intervention.

Collaborators and Investigators

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

Investigators

  • Study Director: Hala I. Kassem, Professor, Professor of physical therapy

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)

November 1, 2021

Primary Completion (Anticipated)

January 30, 2022

Study Completion (Anticipated)

February 10, 2022

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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