NCT05411328

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

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

June 6, 2022

Last Update Submit

August 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in overall stability index

    change in overall stability index will measured by using biodex balance system

    [Time Frame: baseline and after 3 months of intervention.]

Study Arms (2)

traditional physical therapy group

EXPERIMENTAL

received traditional physical therapy protocol

Device: virtual reality

virtual reality group

EXPERIMENTAL

received the same traditional physical therapy in addition to virtual reality games

Device: virtual reality

Interventions

All children in the two groups received physical therapy protocol for 30 minutes in addition to virtual reality game traditional physical therapy group traditional physical therapy group

traditional physical therapy groupvirtual reality group

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ataxic cerebral palsy aged 9-14 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 Design

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

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 9, 2022

Study Start

November 1, 2022

Primary Completion

April 15, 2024

Study Completion

April 30, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Locations