Development of a Robotic Ankle Assist Device

BiOMOTUM, Inc.31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Palsy

Interventions

Eligibility

Sex: ALLMin age: 8 YearsMax age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Preferred Walking Speed

How fast someone prefers to walk

Time frame: baseline and post intervention at 6 minutes

Secondary Outcomes

Change in COT

Change in Metabolic cost of transport

Time frame: baseline and post intervention

Change in 6MWT

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

Time frame: 6 minutes pre/post

Change in Gait Kinetics

Change in Average knee angle across stance phase measured in degrees

Time frame: 6 minutes pre/post

Change in Step Length

Step length during walking

Time frame: 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.

Time frame: 20 minutes pre/post

Change in Fast Walking Speed

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

Time frame: baseline and post intervention

Development of a Robotic Ankle Assist Device

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes