Optimal Dosing of High-Intensity Locomotor Training for Step Attainment and Locomotor Outcomes in Stroke Patients Undergoing Acute Inpatient Rehabilitation

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorNYU Langone Health

About this trial

The purpose of this study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing inpatient rehabilitation (IR) in the subacute phase of stroke recovery.

This is a randomized controlled trial conducted at a single IR facility. Investigators will randomize patients to receive one of two distinct HIGT interventions or a high step count intervention during standard care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Weightbearing restrictions, uncontrolled cardiopulmonary, metabolic, infectious, or psychiatric disorders, which would preclude aerobic locomotor training

Estimated length of stay of less than 14 days

Non-ambulatory status prior to admission (unable to walk >50 meters)

Pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

  • Moderate-Intensity Locomotor Training Program

    Behavioral

    The moderate-intensity program prescribes participants to exert 50-59% of their heart rate (HR) reserve, or a score of 13-15 on Borg's rating of perceived exertion (RPE) scale.

  • High-Intensity Locomotor Training Program

    Behavioral

    The high-intensity program prescribes participants to exert at least 60% of their heart rate (HR) reserve, or a score of 16-18 on the RPE scale.

  • High-Step Count Locomotor Training Program

    Behavioral

    The high step count program prescribes at least 600 steps per session, at less than 50% or HR reserve, or less than 13 RPE.

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Moderate-Intensity Locomotor Training ProgramExperimental treatment 1 intervention
Group B: High-Intensity Locomotor Training ProgramExperimental treatment 1 intervention
Group C: High-Step Count Locomotor Training ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Berg Balance Scale (BBS) Score

The BBS is a 14-item objective assessment that static balance and fall risk in adults. Each item is rated on a scale from 0-4. The total score is the sum of responses and ranges from ranges from 0 to 56, with lower scores indicating a higher risk of falling and lower functional mobility.

Time frame
Discharge Assessment (Day 13-14)
2

Ten Meter Walk Test (10mWT) Time

The 10mWT is an assessment of walking speed in meters per second over a distance of 10 meters.

Time frame
Discharge Assessment (Day 13-14)
3

Six Minute Walk Test (6MWT) Distance

The 6MWT is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants walk around the perimeter of a set circuit for a total of six minutes. The measure is the total distance covered in six minutes.

Time frame
Discharge Assessment (Day 13-14)
4

Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) - Admission Quality Indicator (QI) Score: Transfers

The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (transfer) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.

Time frame
Discharge Assessment (Day 13-14)

Secondary outcomes

1

Number of Patients Discharged at Home

Time frame
Discharge Assessment (Day 13-14)
2

Number of Patients Discharged at Subacute Rehabilitation Facility

Time frame
Discharge Assessment (Day 13-14)
3

Number of Steps of Locomotor Training

Measurement of adherence to protocols.

Time frame
Discharge Assessment (Day 13-14)
4

Time Spent in Locomotor Training

Measurement of adherence to protocols.

Time frame
Discharge Assessment (Day 13-14)

Other outcomes

Sponsors and contacts

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NYU Langone Health

Lead sponsor

National Institutes of Health (NIH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: