Recruiting

High vs. Low-frequency

Sponsor:

Indiana University

Code:

NCT06612723

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

high-intensity gait training

Physical activity coaching

Study Details

Brief summary:

The purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.

Conditions

Stroke

Study ID

NCT06612723

Start date

Sep 16, 2024

Status verified date

Jan, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Unilateral deficits following stroke \> 6 months prior; however individuals \> 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until \> 6 months
  • Age 18-85
  • Weight \< 350 pounds
  • Able to follow 3-step commands
  • Able to ambulate with self-selected gait speeds between 0.10-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
  • Lower extremity Fugl-Meyer \< 34
  • Medical clearance to participate

Exclusion Criteria:

  • Evidence of cerebellar ataxia
  • Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities such that, in the judgement of the PI, could compromise the safety of the participant, limit the ability to complete the study, or compromise the objectives of the study.
  • Currently participating in other physical therapy
  • \>50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High frequency

Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks

active comparator: Low frequency

Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks

Interventions

high-intensity gait training

Individuals will perform up to 40 minutes of walking practice during 60 minute sessions while targeting heart rates of at least 70% heart rate reserve.

Physical activity coaching

Individuals will receive feedback on the minutes of walking activity performed on non-training days and provided coaching strategies to increase this metric.

Primary outcome measure

  • 6-minute walk test [ Time Frame: After 12 weeks ]

Central Contacts and Locations

Central contacts

Christopher Henderson, PhD

317-329-2353henderce@iu.edu

Thomas G Hornby, PhD

317-329-2353tghornby@iu.edu

Locations

Rehabilitation Hospital of Indiana

Recruiting

Indianapolis, Indiana, United States, 46254

Contacts

Alicia Ward, MS

317-329-2353alicward@iu.edu

Principal Investigator:

Christopher Henderson, PhD

More Information

Sponsor

Indiana University

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

  • stroke
  • gait
  • rehabilitation
  • high-intensity
  • frequency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-01-27.