Development of a Robotic Ankle Assist Device

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

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 Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Robotic Ankle Assist Device (RAAD)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Flagstaff, Arizona, United States, 86011
      • Northern Arizona University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapist supervised resistance training; Resistance training with the RAAD under therapist supervision.	Device: Robotic Ankle Assist Device (RAAD); 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
Experimental: Therapist supervised assistance training; Assistance training with the RAAD under therapist supervision.	Device: Robotic Ankle Assist Device (RAAD); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Preferred Walking Speed	How fast someone prefers to walk	baseline and post intervention at 6 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in COT	Change in Metabolic cost of transport	baseline and post intervention
Change in 6MWT	Change in Six-minute walk test, which is the total distance walked over a 6 minute period.	6 minutes pre/post
Change in Gait Kinetics	Change in Average knee angle across stance phase measured in degrees	6 minutes pre/post
Change in Step Length	Step length during walking	baseline and post intervention
Change in Gross Motor Function Measure Scale 66	Change in Gross motor function measure scale 66, min score = 0, max score = 66, high score is better. Unit of measure = Scores on a scale.	20 minutes pre/post
Change in Fast Walking Speed	How fast participants prefer to walk quickly (m/s)	baseline and post intervention

Collaborators and Investigators

• Sponsor: BiOMOTUM, Inc.
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Shirley Ryan AbilityLab; Northern Arizona University; Gillette Children's Specialty Healthcare
• Investigators: Principal Investigator: Ray Browning, PhD, BiOMOTUM, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 1R44HD104328 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes