High vs Low-frequency of High-intensity Training in Chronic Stroke (F-ITT)

Indiana University

Status: Enrolling

Conditions: Stroke

Treatments: Other: high-intensity gait training; Behavioral: Physical activity coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT06612723

24114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

High frequency

Experimental group

Description:

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

Treatment:

Behavioral: Physical activity coaching

Other: high-intensity gait training

Low frequency

Active Comparator group

Description:

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

Treatment:

Behavioral: Physical activity coaching

Other: high-intensity gait training