Clinical trial NCT06244901: Community Testing of Wearable Assistance
Official title: Community Testing of Wearable Assistance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cerebral Palsy
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Walking speed
timeFrame: through study completion, an average of one week
Secondary outcomes:
measure: Step length
timeFrame: Through study completion, an average of one week
measure: Heart-rate
timeFrame: Through study completion, an average of one week
measure: Perceived exertion
timeFrame: Through study completion, an average of one week
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
Study officials:
References: