- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494890
Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment
Walking impairment following neurologic injury can increase the energy cost of walking threefold, acting as a functional barrier to independence. The goal of this cross-sectional study is to determine the measurement properties of a novel biomechanical cost of walking measure in chronic stroke capable of pinpointing the origins of movement inefficiencies. This research aims to:
- determine the convergent validity of biomechanical cost of walking with functional measures in relation to metabolic cost of walking,
- determine the reliability of biomechanical cost of walking in relation to metabolic cost of walking,
- determine the responsiveness of biomechanical cost of walking in relation to metabolic cost of walking.
Individuals with walking impairment from stroke will complete three 5-minute comfortable speed treadmill walking trials. The 3rd walking trial will be against resistance to increase cost of walking. This single session study will compare the metric properties of biomechanical cost of walking in relation to metabolic cost of walking.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christina Garrity, DPT
- Phone Number: (513) 558-7499
- Email: garritca@mail.uc.edu
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45206
- Recruiting
- University of Cincinnati - Digital Futures
-
Contact:
- Christina Garrity, DPT
- Phone Number: (513) 558-7499
- Email: garritca@mail.uc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 30-80 years at the time of consent
- Hemiparesis from ischemic and/or hemorrhagic strokes
- Most recent stroke for which participant sought treatment, at least 3 months prior to study consent
- Walking speed <1.0 m/s on the 10-meter walk test
- Able to walk 10m over ground with assistive devices as needed
- Able to walk at least 5 minutes continuously on the treadmill ≥ 0.1 mile per hour
- No contraindications to exercise according to ACSM guidelines
- Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
Exclusion Criteria:
- Hospitalization for cardiac or pulmonary disease within past 3 months
- Implanted pacemaker or defibrillator
- Severe lower limb hypertonia (Ashworth >2)
- Foot drop or lower limb joint instability without adequate stabilizing device
- Clinically significant neurologic disorder other than stroke
- Other significant medical condition likely to jeopardize safety (e.g. joint contracture, gait limited by pain)
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treadmill walking with and without resistance
|
Comfortable speed treadmill walking with resisted forward progression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constituent Lower Extremity Work
Time Frame: 1st minute and 5th minute of resisted walking trial versus non-resisted walking trial.
|
Energy expenditure calculated using biomechanical variables such as force and limb motion
|
1st minute and 5th minute of resisted walking trial versus non-resisted walking trial.
|
|
Metabolic Cost of Walking
Time Frame: 1st minute and 5th minute of resisted walking trial versus non-resisted walking trial.
|
Energy expenditure calculated using oxygen consumption and carbon dioxide production
|
1st minute and 5th minute of resisted walking trial versus non-resisted walking trial.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina Garrity, DPT, University of Cincinnati
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 2024-0863-03
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
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.
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