Measurement Properties of Mechanical Cost of Walking for... | NCT07494890

Studies
Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment

NCT07494890

Sponsor

University of Cincinnati

Status

Recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

18Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

Resisted walking

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2026Actual

Primary Completion Date

Mar 1, 2027Estimated

Completion Date

Mar 1, 2027Estimated

First Submitted Date

Mar 20, 2026

First Submission Date that Met QC Criteria

Mar 20, 2026

First Posted Date

Mar 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treadmill walking with and without resistance	Experimental		Behavioral: Resisted walking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resisted walking	Behavioral	Comfortable speed treadmill walking with resisted forward progression.	Treadmill walking with and without resistance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Constituent Lower Extremity Work	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	Energy expenditure calculated using oxygen consumption and carbon dioxide production	1st minute and 5th minute of resisted walking trial versus non-resisted walking trial.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christina Garrity, DPT	Contact	(513) 558-7499		garritca@mail.uc.edu

Overall Officials

Name	Affiliation	Role
Christina Garrity, DPT	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati - Digital Futures	Recruiting	Cincinnati	Ohio	45206	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided