Stroke Clinical Trial
Official title:
Treatment of Hemiparetic Gait Impairments Using Telehealth With the Moterum iStride Solution™
Verified date | September 2022 |
Source | Moterum Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this research is to investigate the feasibility of delivering gait treatment using the Moterum iStride Solution™ to individuals with hemiparetic gait impairments using a telemedicine modality, the Moterum Digital Platform.
Status | Completed |
Enrollment | 6 |
Est. completion date | December 21, 2020 |
Est. primary completion date | December 19, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age 21-80 - Caregiver support. The caregiver should be an adult over the age of 18 without physical or cognitive limitations which would prohibit them from being able to provide appropriate assistance to the device user - Hemiparesis - If hemiparesis is due to a stroke, the stroke occurred at least 3 months prior to enrollment - Gait asymmetry - Able to walk independently with or without a cane or hemiwalker, (Modified Rankin Score 3 or less) - No evidence of severe cognitive impairment that would interfere with understanding the instructions - At least 25 feet of walking space (does not need to be a straight line) - Weight does not exceed 275lbs Exclusion Criteria: - Uncontrolled seizures - Metal implants (stents, clips, pacemaker) - Pregnancy - Chronic Obstructive Pulmonary Disease - Uncontrolled blood pressure - Myocardial infarction within the last 180 days - Cannot rely on a rolling walker for ambulation - Severe ataxia interfering with safety on the device - Previously diagnosed vestibular ear issues interfering with safety on the device |
Country | Name | City | State |
---|---|---|---|
United States | Moterum Technologies, Inc. (study location: homes throughout United States) | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Moterum Technologies, Inc. |
United States,
Handzic I, Barno EM, Vasudevan EV, Reed KB. Design and Pilot Study of a Gait Enhancing Mobile Shoe. Paladyn. 2011 Dec 1;2(4). doi: 10.2478/s13230-012-0010-7. — View Citation
Handzic I, Vasudevan E, Reed KB. Developing a Gait Enhancing Mobile Shoe to Alter Over-Ground Walking Coordination. IEEE Int Conf Robot Autom. 2012 May;2012:4124-4129. — View Citation
Kim SH, Huizenga DE, Handzic I, Ditwiler RE, Lazinski M, Ramakrishnan T, Bozeman A, Rose DZ, Reed KB. Relearning functional and symmetric walking after stroke using a wearable device: a feasibility study. J Neuroeng Rehabil. 2019 Aug 28;16(1):106. doi: 10.1186/s12984-019-0569-x. — View Citation
Reed KB, Handzic, Ismet, Inventor; University of South Florida, assignee. Gait Altering Shoes. US patent 9,295,302. March 29, 2016, 2016.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of safely implementing the treatment protocol | The described delivery method includes using remote physical therapist treatment oversight and physical supervision of treatment activities by trained caregivers. Due to the inclusion criteria, patients already have some risk of falls and need for assistance while walking. The caregivers will record assistance levels provided during treatment. Any adverse events will be immediately reported and reviewed. The remote physical therapists will regularly review assistance levels to ensure the participant is requiring an appropriate level of assistance. The feasibility of safely delivering treatment will be assessed by two measures: (a) the daily safety rate, defined as the percentage of days an adverse event occurred out of the total number of treatment days, and (2) assistance required and adverse events experienced for each participant, compared to the group, and compared to our prior research. | Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment). | |
Primary | Achievability of telemedicine delivery protocol | The achievability of this treatment delivery method will be assessed by measuring participant compliance to the protocol tasks. These tasks include scheduled treatment sessions, functional and psychosocial outcome measures, and sensor-based activities. Achievability will be defined as the percentage of completed protocol activities out of the total scheduled activities. | Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period. | |
Secondary | Feasibility of screening criteria | To enroll patients via telemedicine, the eligibility criteria will be assessed with an additional video gait review performed by physical therapists. The feasibility of screening patients at a distance will be assessed by measuring screening performance, defined as the percentage of enrolled subjects who are removed from the study after later being deemed ineligible (for example, gait is not asymmetric or hemiparetic but appeared so on video, or patient cannot walk independently, etc.) out of all enrolled subjects. | Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment). | |
Secondary | Stakeholder Acceptability | Participant and caregiver feedback will be necessary to determine preferences and sentiments regarding the delivery method including technology management, training procedures, protocol activities, adequacy of caregiver and therapist support, device benefit, and overall satisfaction with procedures. Feedback will be gathered through a questionnaire using five-point Likert scales and open-ended questions. Questionnaires will be provided after completion of outcome measures at the final, 12-month follow-up assessment. Acceptability will be determined through percentage of positive responses out of the total questionnaire items. | Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period. |
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