Development of a Robotic Ankle Assist Device

Phase 1

Completed

Conditions: Cerebral Palsy

Interventions: Device: Robotic Ankle Assist Device (RAAD)

Registration Number: NCT04516343

Lead Sponsor: BiOMOTUM, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapist-guided training	Robotic Ankle Assist Device (RAAD)	Therapist-guided gait training with the RAAD.
Parent supervised resistance training	Robotic Ankle Assist Device (RAAD)	Resistance training under parent supervision.
User testing	Robotic Ankle Assist Device (RAAD)	Two sessions of user-centric testing.
Assistance training	Robotic Ankle Assist Device (RAAD)	Assistance training with the RAAD
Therapist supervised resistance training	Robotic Ankle Assist Device (RAAD)	Resistance training with the RAAD under therapist supervision.

Primary Outcome Measures

Name	Time	Method
Change in Preferred Walking Speed	baseline and post intervention at 6 minutes	How fast someone prefers to walk

Secondary Outcome Measures

Name	Time	Method
Change in COT	baseline and post intervention	Change in Metabolic cost of transport
Change in 6MWT	6 minutes pre/post	Change in Six-minute walk test, which is the total distance walked over a 6 minute period.
Change in Gait Kinetics	6 minutes pre/post	Change in Average knee angle across stance phase measured in degrees
Change in Step Length	baseline and post intervention	Step length during walking
Change in Gross Motor Function Measure Scale 66	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.
Change in Fast Walking Speed	baseline and post intervention	How fast participants prefer to walk quickly (m/s)