PedBot Ankle Rehablitation

Active, not recruiting

• Conditions: Cerebral Palsy

• Registration Number: NCT05825508
• Lead Sponsor: Children's National Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-07-28
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-07-28
• Study Completion: 2025-07-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Cerebral palsy

Exclusion Criteria

• Healthy volunteers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of days used	90 days	integer

Trial Locations

Locations (1)

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States