NCT05227066

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

January 6, 2022

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • antero-posterior stability index

    baseline and after 3 months of intervention.

  • mediolateral stability index

    baseline and after 3 months of intervention.

Study Arms (2)

traditional physical therapy group

EXPERIMENTAL

received traditional physical therapy protocol

Other: traditional physical therapy group

lower extremity weights group

EXPERIMENTAL

received the same traditional physical therapy in addition to lower extremity weights

Other: adding lower extremity weightsOther: traditional physical therapy group

Interventions

traditional physical therapy group

lower extremity weights grouptraditional 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

lower extremity weights group

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ataxic cerebral palsy aged 7-13 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta University for Science and Technology

Gamasa, Dakahelia, 4030, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy, Ataxic, Autosomal Recessive

Study Officials

  • Hala I. Kassem, Professor

    Professor of physical therapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

January 6, 2022

First Posted

February 7, 2022

Study Start

January 5, 2025

Primary Completion

December 15, 2025

Study Completion

December 20, 2025

Last Updated

December 18, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Locations