Clinical trial NCT04516343: Development of a Robotic Ankle Assist Device
Official title: Development of a Robotic Ankle Assist Device to Improve Mobility in Individuals With Movement Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebral Palsy
Lead sponsor: BiOMOTUM, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Northern Arizona University
name: Gillette Children's Specialty Healthcare
name: Shirley Ryan AbilityLab
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-08-18
Enrollment: 31
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study has two experiments. In experiment I, participants will be recruited to complete gait training with the RAAD under assistance mode. In experiment two, participants will be recruited to complete gait training with the RAAD under resistance mode.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Preferred Walking Speed
timeFrame: baseline and post intervention at 6 minutes
Secondary outcomes:
measure: Change in COT
timeFrame: baseline and post intervention
measure: Change in 6MWT
timeFrame: 6 minutes pre/post
measure: Change in Gait Kinetics
timeFrame: 6 minutes pre/post
measure: Change in Step Length
timeFrame: baseline and post intervention
measure: Change in Gross Motor Function Measure Scale 66
timeFrame: 20 minutes pre/post
measure: Change in Fast Walking Speed
timeFrame: baseline and post intervention
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
Study officials:
affiliation: BiOMOTUM, Inc.
name: Ray Browning, PhD
role: PRINCIPAL_INVESTIGATOR
References: