Development of a Robotic Ankle Assist Device

Biomotum

Status and phase: Completed; Phase 1

Conditions: Cerebral Palsy

Treatments: Device: Robotic Ankle Assist Device (RAAD)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04516343

1R44HD104328

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Therapist supervised assistance training

Experimental group

Description:

Assistance training with the RAAD under therapist supervision.

Treatment:

Device: Robotic Ankle Assist Device (RAAD)

Therapist supervised resistance training

Experimental group

Description:

Resistance training with the RAAD under therapist supervision.

Treatment:

Device: Robotic Ankle Assist Device (RAAD)