Development of a Robotic Ankle Assist Device

NCT04516343 | Completed Phase 1 Results FDA Device

• 1 other identifier: 1R44HD104328
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Change in Preferred Walking Speed

  How fast someone prefers to walk

  baseline and post intervention at 6 minutes

Secondary Outcomes (6)

• Change in COT

  baseline and post intervention

• Change in 6MWT

  6 minutes pre/post

• Change in Gait Kinetics

  6 minutes pre/post

• Change in Step Length

  baseline and post intervention

• Change in Gross Motor Function Measure Scale 66

  20 minutes pre/post

Study Arms (2)

Therapist supervised assistance training

EXPERIMENTAL

Assistance training with the RAAD under therapist supervision.

Device: Robotic Ankle Assist Device (RAAD)

Therapist supervised resistance training

EXPERIMENTAL

Resistance training with the RAAD under therapist supervision.

Device: Robotic Ankle Assist Device (RAAD)

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

Therapist supervised assistance training; Therapist supervised resistance training

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP.
• Able to understand and follow simple directions. Able to complete 5 heel raises with minimal assistance (balance only). At least 20 degrees of passive ankle plantar flexion range of motion.

You may not qualify if:

• Knee extension or ankle dorsiflexion contractures greater than 15 degrees. Health condition or diagnosis other than CP that would affect safe participation.
• Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.

Sponsors & Collaborators

• BiOMOTUM, Inc.: lead
• Northern Arizona University: collaborator
• Gillette Children's Specialty Healthcare: collaborator
• Shirley Ryan AbilityLab: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Some participants were unable to complete all assessment tests leading to small sample sizes.

Results Point of Contact

• Title: Chief Science Officer
• Organization: Biomotum

zach@biomotum.com

(800) 566-2531

Study Officials

• Ray Browning, PhD

  BiOMOTUM, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study has two experiments. In experiment I, participants will be recruited to complete gait training with the RAAD under assistance mode. In experiment two, participants will be recruited to complete gait training with the RAAD under resistance mode.

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: November 1, 2020
• Primary Completion: August 15, 2024
• Study Completion: August 31, 2024
• Last Updated: April 4, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)