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NCT Number: NCT06612723

High vs Low-frequency of High-intensity Training in Chronic Stroke

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location status: Recruiting

Location contact

Alicia Ward, MS

CONTACT

[email protected]

317-329-2353

Christopher Henderson, PhD

PRINCIPAL_INVESTIGATOR

Thomas G Hornby, PhD

SUB_INVESTIGATOR

About this study

This study will utilize a 2 arm randomized trial to investigate potential differences in locomotor and community outcomes following 18 visits of high-intensity gait training provided over 6 weeks (high frequency) or 12 weeks (low frequency). Following confirmation of eligibility and baseline testing, individuals will be randomized to either high or low frequency of training and complete subsequent testing at 6 weeks, 12 weeks, and 24 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high-intensity gait training

Other

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

Behavioral

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

Primary outcomes

  1. 6-minute walk test

    Time frame: After 12 weeks

    Individuals will be asked to "cover as much ground as possible" over 6 mins. Heart rate will additionally be measured during this assessment (distance in m)

Secondary outcomes

  1. Peak treadmill speed

    Time frame: After 12 weeks

    Individuals will participate in a walking-based graded exercise test. While harnessed for safety, a motorized treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due: 1) requests to stop, 2) unable to keep up with the treadmill and/or loses their balance, 3) absolute exercise test termination criteria provided by ACSM. The highest speed that the individual can walk for a minute at is the peak treadmill speed.

Other outcomes

  1. Functional Gait Assessment

    Time frame: After 12 weeks

    10 item assessment of dynamic balance. Example tasks include walking with head turns, with eyes closed, and walking backwards.

  2. 30 second Sit to Stand Test

    Time frame: After 12 weeks

    Participants will be asked to rise from a chair without using their arms and then return to sitting as many times as possible in 30 seconds.

  3. Activity-Specific Balance Confidence (ABC) Scale

    Time frame: After 12 weeks

    This questionnaire asks individuals to rate their balance-confidence from 0 (no confidence) to 100 (completely confident) during a variety of 16 commonly performed tasks such as walking around a house or getting into a car.

  4. Oxygen Consumption

    Time frame: After 12 weeks

    Oxygen consumption will be measured via a portable metabolic cart (K5; COSMED) during the previously described graded exercise test. Participant will wear a snug fitting mask that covers their mouth and nose, but does not affect the amount or quality of air that they breathe. The mask will be connected to a small backpack that collects information on the rate of breathing and oxygen consumed.

  5. Medical Outcomes Survey Short-Form 36 (SF-36)

    Time frame: After 12 weeks

    This 36-question survey asks individuals about how their current health may limit their ability to perform typical physical and social activities.

  6. Steps per Day

    Time frame: After 12 weeks

    Participants will wear a research-grade pedometer (StepWatch; Modus Health) during waking hours for ~1-2 weeks before beginning the training protocol, during the intervention period, and after completing training protocol to quantify home and community mobility. Participants will also be asked to document their daily minutes walked for exercise, number of walking bouts, where they performed the activity, and subjectively how hard they were working while walking for exercise.

  7. Gait speed

    Time frame: After 12 weeks

    This is an assessment of overground walking speed measured across a distance of ~20 feet and will be conducted at both self-selected (instructions: "walk at your usual, comfortable pace") and fastest (instructions: "walk as fast as you safely can") walking speeds on a pressure sensitive mat (speed in m/s; Zeno Walkway).

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Henderson, PhD

CONTACT

[email protected]

317-329-2353

Thomas G Hornby, PhD

CONTACT

[email protected]

317-329-2353

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: F-ITT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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