Evaluating Wearable Robotic Assistance on Gait

Northern Arizona University (NAU)

Status and phase: Completed; Early Phase 1

Conditions: Cerebral Palsy

Treatments: Device: powered orthosis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04119063

986744

1R15HD099664-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).

Full description

Individuals with cerebral palsy completed high frequency over-ground gait training (4x/week for 1 week) with ankle exoskeleton assistance, and then, after a 1 year washout period, the same participants will complete low frequency over-ground gait training (2x/week for 2 weeks).

Enrollment: 6 patients

Sex: All

Ages: 5 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 5 and 35 years old, inclusive.
• Either a healthy volunteer or a diagnosis of a neurologically-based walking disorder due to stroke, spinal cord injury, Parkinson's disease, or cerebral palsy.
• Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
• Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
• The ability to read and understand English.
• Able to walk at least 30 feet with or without a walking aid (GMFCS Level I-III for individuals with cerebral palsy)

Exclusion criteria

• Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than stroke, spinal cord injury, Parkinson's disease or cerebral palsy that would affect the ability to walk as directed for short periods of time.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Gait Training with Exoskeleton Assistance

Experimental group

Description:

Gait training with ankle exoskeleton assistance. All participants received high frequency gait training followed by a washout period then low frequency gait training.

Treatment:

Device: powered orthosis