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OpenTrials
Completed

NCT Number: NCT04516343

Development of a Robotic Ankle Assist Device

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in Preferred Walking Speed

    Time frame: baseline and post intervention at 6 minutes

    How fast someone prefers to walk

Secondary outcomes

  1. Change in COT

    Time frame: baseline and post intervention

    Change in Metabolic cost of transport

  2. Change in 6MWT

    Time frame: 6 minutes pre/post

    Change in Six-minute walk test, which is the total distance walked over a 6 minute period.

  3. Change in Gait Kinetics

    Time frame: 6 minutes pre/post

    Change in Average knee angle across stance phase measured in degrees

  4. Change in Step Length

    Time frame: baseline and post intervention

    Step length during walking

  5. Change in Gross Motor Function Measure Scale 66

    Time frame: 20 minutes pre/post

    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.

  6. Change in Fast Walking Speed

    Time frame: baseline and post intervention

    How fast participants prefer to walk quickly (m/s)

Sponsors and collaborators

Lead sponsor

BiOMOTUM, Inc.

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Gillette Children's Specialty Healthcare
  • Northern Arizona University
  • Shirley Ryan AbilityLab

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2020
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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