Community Testing of Wearable Assistance

Northern Arizona University (NAU)

Status and phase: Enrolling; Early Phase 1

Conditions: Cerebral Palsy

Treatments: Device: Ankle Exoskeleton; Other: Normal walking

Study type: Interventional

Funder types: Other

Identifiers

NCT06244901

2137424

Details and patient eligibility

About

This feasibility study looks to evaluate ankle exoskeleton assistance in community settings for individuals with cerebral palsy.

Full description

Participants will undergo consent (if not done over the phone), history/physical/activity questionnaire, and orthotic device fitting. Following device fitting, the participants will practice walking with powered assistance.

Next, participants will complete "pre" walking tests with and without the device (order randomized) on a 15-minute pre planned community walk in close proximity with their own home. Distance, time, heart-rate, and perceived exertion will be recorded. The expected duration is 1-2 hours.

Next, participants will be asked to complete (under parental supervision for minors) the pre-determined walking route every day for 1 week with or without ankle exoskeleton assistance (block randomized). Following the first week of independent walking practice, participants will complete "post" walking tests with and without the device on the same walking route. Distance, time, heart-rate, and perceived exertion will be recorded. The expected duration is 1-2 hours.

Participants will then have a 2-6 week washout period.

Following this washout, the pre- and post-assessments will be completed before and after, respectively, another week of identical community walking practice completed under the remaining condition (either exoskeleton or no exoskeleton).

Enrollment: 10 estimated patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cerebral palsy
• Gross Motor Function Classification Level I, II, or III
• Able to walk for at least 20 minutes with or without a walking aid
• Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking
• Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.

Exclusion criteria

• Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time.
• Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

Exoskeleton Walking

Experimental group

Description:

Walking with ankle exoskeleton assistance

Treatment:

Device: Ankle Exoskeleton

Normal walking

Placebo Comparator group

Description:

Walking under normal conditions (no exoskeleton)

Treatment:

Other: Normal walking