Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06612723
Acronym
F-ITT
Enrollment
40
Registered
2024-09-25
Start date
2024-09-16
Completion date
2026-10-01
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, gait, rehabilitation, high-intensity, frequency

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.

Detailed description

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.

Interventions

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.

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

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
6-minute walk testAfter 12 weeksIndividuals 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

MeasureTime frameDescription
Peak treadmill speedAfter 12 weeksIndividuals 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.

Countries

United States

Contacts

CONTACTChristopher Henderson, PhD
henderce@iu.edu317-329-2353
CONTACTThomas G Hornby, PhD
tghornby@iu.edu317-329-2353
PRINCIPAL_INVESTIGATORThomas G Hornby, PhD

Indiana University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026