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

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

• Status: Active, not recruiting
• Conditions: Ataxic Cerebral Palsy
• Intervention / Treatment: Other: traditional physical therapy group; Other: adding lower extremity weights

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: traditional physical therapy group; received traditional physical therapy protocol	Other: traditional physical therapy group; traditional physical therapy group
Experimental: lower extremity weights group; received the same traditional physical therapy in addition to lower extremity weights	Other: traditional physical therapy group; traditional physical therapy group; Other: adding lower extremity weights; 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	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	change in antero-posterior stability index will measured by using biodex balance system	baseline and after 3 months of intervention.
mediolateral stability index	change in mediolateral stability index will measured by using biodex balance system	baseline and after 3 months of intervention.

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology
• Investigators: Study Director: Hala I. Kassem, Professor, Professor of physical therapy

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2025
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 20, 2025

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 (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Dyskinesias; Cerebral Palsy, Ataxic, Autosomal Recessive
• Other Study ID Numbers: Ataxic CP

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