Clinical trial NCT06612723: High vs Low-frequency of High-intensity Training in Chronic Stroke
Official title: High vs Low-frequency of High-intensity Training in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
gait
rehabilitation
high-intensity
frequency
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Unilateral deficits following stroke \&gt; 6 months prior; however individuals \&gt; 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until \&gt; 6 months
* Age 18-85
* Weight \&lt; 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 \&lt; 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
* \&gt;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

Primary outcomes:
measure: 6-minute walk test
timeFrame: After 12 weeks
Secondary outcomes:
measure: Peak treadmill speed
timeFrame: After 12 weeks
Other outcomes:
measure: Functional Gait Assessment
timeFrame: After 12 weeks
measure: 30 second Sit to Stand Test
timeFrame: After 12 weeks
measure: Activity-Specific Balance Confidence (ABC) Scale
timeFrame: After 12 weeks
measure: Oxygen Consumption
timeFrame: After 12 weeks
measure: Medical Outcomes Survey Short-Form 36 (SF-36)
timeFrame: After 12 weeks
measure: Steps per Day
timeFrame: After 12 weeks
measure: Gait speed
timeFrame: After 12 weeks
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
Study officials:
affiliation: Indiana University
name: Thomas G Hornby, PhD
role: PRINCIPAL_INVESTIGATOR
References: