NCT07494890

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:

  1. 1.determine the convergent validity of biomechanical cost of walking with functional measures in relation to metabolic cost of walking,
  2. 2.determine the reliability of biomechanical cost of walking in relation to metabolic cost of walking,
  3. 3.determine the responsiveness of biomechanical cost of walking in relation to metabolic cost of walking.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
10mo left

Started Apr 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

March 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 20, 2026

Last Update Submit

March 20, 2026

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (1)

Treadmill walking with and without resistance

EXPERIMENTAL
Behavioral: Resisted walking

Interventions

Resisted walkingBEHAVIORAL

Comfortable speed treadmill walking with resisted forward progression.

Treadmill walking with and without resistance

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati - Digital Futures

Cincinnati, Ohio, 45206, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christina Garrity, DPT

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Garrity, DPT

CONTACT

(513) 558-7499garritca@mail.uc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist, PhD Student

Study Record Dates

First Submitted

March 20, 2026

First Posted

March 27, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations

US(1)