Recruiting

Biomechanical Cost

Sponsor:

University of Cincinnati

Code:

NCT07494890

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Resisted walking

Study Details

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

Conditions

Stroke

Study ID

NCT07494890

Start date

Jun 25, 2026

Status verified date

Mar, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Treadmill walking with and without resistance

Interventions

Resisted walking

Comfortable speed treadmill walking with resisted forward progression.

Primary outcome measure

  • Constituent Lower Extremity Work [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Locations

University of Cincinnati - Digital Futures

Recruiting

Cincinnati, Ohio, United States, 45206

Contacts

More Information

Sponsor

University of Cincinnati

Last update posted

Jul 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-07-06.