Cerebral Palsy
Conditions
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).
Interventions
DEVICEAnkle Exoskeleton
Walking for twenty minutes with a wearable powered robotic ankle exoskeleton on real-world terrain every day for a week.
OTHERNormal walking
Normal walking for twenty minutes on real-world terrain every day for a week.
Sponsors
Northern Arizona University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking speed | through study completion, an average of one week | Change in walking speed (measured in meters per second) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Step length | Through study completion, an average of one week | Change in step length (measured in meters) |
| Heart-rate | Through study completion, an average of one week | Change in heart rate (measured in beats per minute) |
| Perceived exertion | Through study completion, an average of one week | Change in perceived exertion (measured on a 1-10 scale) |
Countries
United States
Contacts
Primary ContactZach Lerner, PhD
Outcome results
None listed