CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Robotic Ankle Assist Device (RAAD)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04516343
NCT04516343Phase 1Completed

Development of a Robotic Ankle Assist Device to Improve Mobility in Individuals With Movement Disorders

BiOMOTUM, Inc.·interventional·Posted Aug 18, 2020·Updated Apr 4, 2025

In Brief

A Phase 1 clinical trial evaluating Robotic Ankle Assist Device (RAAD) for Cerebral Palsy. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy. The first specific goal is to assess the benefits of repeated gait training with RAAD assistance. Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention. The second specific goal is to separately assess the benefits of repeated gait training with RAAD resistance. Individuals with CP will participate in a 4-week resistance intervention and mobility outcomes will be quantified pre and post intervention. Assessed separately, it is hypothesized that both assistance and resistance training will improve mobility outcomes.

Study Details

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedAug 18, 2020
Enrollment StartNov 1, 2020
Primary CompletionAug 15, 2024
Study CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 5.9 years ago

Interventions

Robotic Ankle Assist Device (RAAD)device

The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP