Community Testing of Wearable Assistance
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Zach Lerner, PhD
- Phone Number: 928-523-1787
- Email: zachary.lerner@nau.edu
Study Locations
-
-
Arizona
-
Flagstaff, Arizona, United States, 86011
- Recruiting
- Northern Arizona University
-
Contact:
- Zach Lerner, PhD
- Phone Number: 928-523-1787
- Email: zachary.lerner@nau.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exoskeleton Walking
Walking with ankle exoskeleton assistance
|
Walking for twenty minutes with a wearable powered robotic ankle exoskeleton on real-world terrain every day for a week.
|
|
Placebo Comparator: Normal walking
Walking under normal conditions (no exoskeleton)
|
Normal walking for twenty minutes on real-world terrain every day for a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking speed
Time Frame: through study completion, an average of one week
|
Change in walking speed (measured in meters per second)
|
through study completion, an average of one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Step length
Time Frame: Through study completion, an average of one week
|
Change in step length (measured in meters)
|
Through study completion, an average of one week
|
|
Heart-rate
Time Frame: Through study completion, an average of one week
|
Change in heart rate (measured in beats per minute)
|
Through study completion, an average of one week
|
|
Perceived exertion
Time Frame: Through study completion, an average of one week
|
Change in perceived exertion (measured on a 1-10 scale)
|
Through study completion, an average of one week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2137424
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.