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 aim is to complete a personal-use feasibility analysis of ankle mobility assistance. It is hypothesized the children will be able to safely walk faster and travel farther in the community when using the RAAD device vs. without the device. The second specific aim is to gather feedback to design and prototype a minimum viable product for use in clinical and community settings. The third specific aim is to quantify the potential for the RAAD system to increase the effectiveness of clinical gait therapy. Individuals with CP will complete three training sessions: RAAD assistance, RAAD resistance and standard of care. Muscle activity and step activity will be measured during each session. It is hypothesized that the RAAD assistance and resistance therapy will improve ankle plantar-flexor muscle activity and treatment session quality compared to traditional physical therapist-guided gait training. The fourth specific aim is to assess the benefits of repeated gait training with RAAD assistance and resistance. Individuals with CP will participate in a 4-week assistance or resistance intervention and mobility outcomes will be quantified pre and post intervention. It is hypothesized that both assistance and resistance training will improve mobility outcomes.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zach Lerner, PhD; Phone Number: 8145714616; Email: zachlerner@BiOMOTUM.com
• Study Contact Backup: Name: Ray Browning, PhD; Phone Number: 9713306800; Email: ray@BiOMOTUM.com

Study Locations

• United States
  • Arizona
    • Flagstaff, Arizona, United States, 86011
      • Recruiting
      • Northern Arizona University
      • Contact: Zachary Lerner, PhD; Phone Number: 814-571-4616; Email: zachlerner@biomotum.com
      • Principal Investigator: Zachary Lerner, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: User testing; Two sessions of user-centric testing.	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-guided training; Therapist-guided gait training with the RAAD.	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: Assistance training; Assistance training with the RAAD	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 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: Parent supervised resistance training; Resistance training under parent 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	6 minutes pre/post
PF activity	Number of steps with mean late stance (i.e. propulsive) ankle plantar flexor activity above pre-session baseline average activity of 5 heel raises	30 minute session
Change in lower extremity muscle activity similarity to the average unimpaired activity pattern	Similarity of muscle activity to the average unimpaired activity pattern calculated via cross-correlation coefficient	6 minutes pre/post

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle muscle co-contraction	Number of steps with mean stance phase ankle co-contraction below pre-session baseline	30 minute session
Qualitative therapist assessment of session quality, participant movement, and device usability via questionnaire	Qualitative therapist assessment of session quality, participant movement quality, and device usability via questionnaire	At the end of the study visit
Minimum age and function level required to don and operate the device without direct parent help	Minimum age and function level required to don and operate the device without direct parent help	At the end of the study visit
Participant questionnaire of exertion, ankle muscle soreness, device usability, comfort, and ease of don/doffing	Qualitative participant assessment of exertion, ankle muscle soreness, device usability, comfort, and ease of don/doffing via questionnaire	At the end of the study visit
COT	Metabolic cost of transport	baseline and post intervention
6MWT	Six-minute walk test	6 minutes pre/post
TUG	Timed up-and-go test	2 minutes pre/post
Gait kinetics	Positive ankle power, and distribution of positive joint power across the lower extremity measured in Watts	6 minutes pre/post
Gait kinematics	Lower extremity joint angles measured in degrees	6 minutes pre/post
VR	Stride-to-stride variability of lower-extremity muscle activity calculated via variance ratio	6 minutes pre/post
VAF1	Variance accounted for by the first muscle synergy	6 minutes pre/post
Plantar-flexor muscle strength via hand held dynamometry	Plantar-flexor muscle strength via hand held dynamometry	1 minutes pre/post
Gross motor function measure scale 66	Gross motor function measure scale 66, min score = 0, max score = 66, high score is better	20 minutes pre/post

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 (ANTICIPATED): September 15, 2024
• Study Completion (ANTICIPATED): December 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): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

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 (NIH)

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