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NCT05825508 Clinical Trial

PedBot Ankle Rehablitation

Cerebral Palsy Clinical Trial

Official title:
PedBot Ankle Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05825508
Other study ID # Pro00013680
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 28, 2022
Est. completion date July 28, 2023

Study information
Verified date April 2023
Source Children's National Research Institute
Contact Kevin Cleary, PhD
Phone 2024765000
Email kcleary@childrensnational.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of the study is to determine engagement with use and adherence to a home exercise program with our PedBotHome ankle rehabilitation device. We will place the device in the home for 90 days and consider the study a success if used for at least 30 minutes a day for at least 3 days a week during this period.

Description:

The major secondary objective is to determine if the range of motion of the ankle has improved through use of PedBotHome. Other secondary objectives will measure ankle strength and control. Secondary outcomes will include a measurable increase in range of motion across the ankle joint (in any direction) and a measurable increase in strength in plantarflexion, dorsiflexion, inversion, and eversion. Improvement in gait and speed of ambulation will also be considered secondary outcome measures as an indication of better ankle control.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date July 28, 2023
Est. primary completion date July 28, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria: - Cerebral palsy Exclusion Criteria: - Healthy volunteers

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ankle robot
home ankle robot and video game

Locations
Country Name City State
United States Children's National Health System Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of days used integer 90 days
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