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Responses to Backward Walking Training Post-Stroke (BRAVE)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Backward Walking Training
Backward Walking Training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Gait, Physical Therapy Modalities, Magnetic Resonance Imaging, Postural Balance, Accidental Falls

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Berg Balance Scale < 42
  • Self-selected 10 meter gait speed < 0.8 m/s
  • Diagnosis of unilateral stroke
  • > 2 months < 4 months post-stroke
  • Able to ambulate at least 10 feet with maximum 1 person assist
  • Medically stable

Exclusion Criteria:

  • Presence of neurological condition other than stroke
  • Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)

    • Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded
  • Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10 degrees, knee flexion ROM < 90 degrees, hip flexion contracture > 25 degrees, and ankle plantar flexion contracture > 15 degrees)
  • Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest
  • Pain upon ambulation
  • Receiving physical therapy services for mobility and/or gait
  • Living in a skilled nursing facility
  • Any MRI contraindication, including but not limited to the presence of metal, MR sensitive implanted medical devices, or claustrophobia

Sites / Locations

  • North Florida/South Georgia Veterans Health System, Gainesville, FLRecruiting
  • Brooks Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

27 session group

18 session group

Arm Description

Participants in this arm will receive 27 sessions of backward walking training.

Participants in this arm will receive 18 sessions of backward walking training.

Outcomes

Primary Outcome Measures

Change in the time to complete the 10 Meter walk Test
Gait speed will be measured with the 10-Meter Walk Test. Individuals will be given a 3 meter warm-up distance for walking, preceding the 10 meter distance and 3 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
Change in the time to complete the Three-Meter Backward Walk Test
BW Speed will be assessed with the 3-Meter Backward Walk test (3MBWT). The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking. An average of two trials will be recorded.
Change in the Functional Gait Assessment
A 10-item clinical gait and balance test of dynamic activities. Reported scores range from 0 to 30 with a larger number representing a better score.
Change in the Activity-Specific Balance Confidence Scale
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. This scale is reported as an average of the 16 items from 0% to 100% with a larger number representing a better score.
Change in the Berg Balance Scale
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. The range of this scale is 0-56 with a larger number representing a better score.

Secondary Outcome Measures

Change in the time to complete the 10 Meter walk Test
Gait speed will be measured with the 10-Meter Walk Test. Individuals will be given a 3 meter warm-up distance for walking, preceding the 10 meter distance and 3 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
Change in the time to complete the Three-Meter Backward Walk Test
BW Speed will be assessed with the 3-Meter Backward Walk test (3MBWT). The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking. An average of two trials will be recorded.
Change in the Functional Gait Assessment
A 10-item clinical gait and balance test of dynamic activities. Reported scores range from 0 to 30 with a larger number representing a better score.
Change in the Activity-Specific Balance Confidence Scale
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. This scale is reported as an average of the 16 items from 0% to 100% with a larger number representing a better score.
Change in the Berg Balance Scale
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. The range of this scale is 0-56 with a larger number representing a better score.

Full Information

First Posted
June 9, 2021
Last Updated
November 18, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04928482
Brief Title
Responses to Backward Walking Training Post-Stroke
Acronym
BRAVE
Official Title
Brain and Behavioral Responses to Backward Walking Training Post-Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. The investigators have previously established the effectiveness of a backward walking training program to improve gait and balance in post-stroke Veterans. To best serve Veterans in this era of personalized medicine, there is a current need to determine the appropriate training dose as well as which post-stroke Veterans would most benefit. This study addresses both needs as it will 1) test responses to two different doses (18 vs. 27 sessions) of backward walking training and 2) assess brain activity, measured by magnetic resonance imaging, before and after training intervention to determine its ability to predict rehabilitation response as well as brain mechanisms of behavioral change.
Detailed Description
This prospective, single-blind, randomized controlled trial will enroll individuals between 2- and 4-months post-stroke and is designed to address the study's three Specific Aims (See Figure below). The study will be approved by an ethics review board and all participants will provide written informed consent. Baseline pre-intervention assessment (Assessment A) will consist of clinical gait and balance assessments and resting state Functional Connectivity MRI and functional MRI. Brain imaging at Assessment A will test the hypotheses that rs-FC and fMRI can predict BWTraining intervention response (Specific Aim 2). Following Assessment A, participants will be randomized to receive 1) 18 sessions or 2) 27-sessions of BWTraining 3x/week for six or nine weeks respectively. Participants in the 18-session group will wait 3 weeks following randomization to begin training such that Assessment B will take place at approximately the same time post-stroke for all participants. This will assure that all participants have had the same duration of time post-stroke after study enrollment to experience spontaneous recovery. Gait and balance measures at Assessment B will be compared to Assessment A to test Specific Aim #1. MRI brain measurements at Assessment B will be compared to those at Assessment A to test the hypotheses of exploratory Aim #3. Assessment C, at six weeks post-intervention will evaluate short-term and Assessment D, at 6-months post-intervention will evaluate long-term retention gains in gait and balance. The investigators will recruit 54 individuals post-stroke to allow up to a 10% attrition rate and still provide a sufficient participant pool (n=48) to address the Specific Aims.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Gait, Physical Therapy Modalities, Magnetic Resonance Imaging, Postural Balance, Accidental Falls

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive either: 1) 27 sessions of backward walking training or 2) 18 sessions of backward walking training
Masking
Outcomes Assessor
Masking Description
Outcome Assessors will be masked to group assignment. Outcome Assessors will not deliver the intervention and will not be present in the building when the intervention is being delivered. Participants will be instructed to not reveal their group assignment to the outcome assessor.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
27 session group
Arm Type
Experimental
Arm Description
Participants in this arm will receive 27 sessions of backward walking training.
Arm Title
18 session group
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive 18 sessions of backward walking training.
Intervention Type
Behavioral
Intervention Name(s)
Backward Walking Training
Intervention Description
Participants will receive 27 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground.
Intervention Type
Behavioral
Intervention Name(s)
Backward Walking Training
Intervention Description
Participants will receive 18 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground.
Primary Outcome Measure Information:
Title
Change in the time to complete the 10 Meter walk Test
Description
Gait speed will be measured with the 10-Meter Walk Test. Individuals will be given a 3 meter warm-up distance for walking, preceding the 10 meter distance and 3 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
Time Frame
Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Title
Change in the time to complete the Three-Meter Backward Walk Test
Description
BW Speed will be assessed with the 3-Meter Backward Walk test (3MBWT). The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking. An average of two trials will be recorded.
Time Frame
Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Title
Change in the Functional Gait Assessment
Description
A 10-item clinical gait and balance test of dynamic activities. Reported scores range from 0 to 30 with a larger number representing a better score.
Time Frame
Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Title
Change in the Activity-Specific Balance Confidence Scale
Description
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. This scale is reported as an average of the 16 items from 0% to 100% with a larger number representing a better score.
Time Frame
Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Title
Change in the Berg Balance Scale
Description
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. The range of this scale is 0-56 with a larger number representing a better score.
Time Frame
Change from baseline to end of study intervention (six or nine weeks depending on intervention arm)
Secondary Outcome Measure Information:
Title
Change in the time to complete the 10 Meter walk Test
Description
Gait speed will be measured with the 10-Meter Walk Test. Individuals will be given a 3 meter warm-up distance for walking, preceding the 10 meter distance and 3 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
Time Frame
Change from baseline through study completion, an average of 7 months.
Title
Change in the time to complete the Three-Meter Backward Walk Test
Description
BW Speed will be assessed with the 3-Meter Backward Walk test (3MBWT). The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking. An average of two trials will be recorded.
Time Frame
Change from baseline through study completion, an average of 7 months.
Title
Change in the Functional Gait Assessment
Description
A 10-item clinical gait and balance test of dynamic activities. Reported scores range from 0 to 30 with a larger number representing a better score.
Time Frame
Change from baseline through study completion, an average of 7 months.
Title
Change in the Activity-Specific Balance Confidence Scale
Description
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. This scale is reported as an average of the 16 items from 0% to 100% with a larger number representing a better score.
Time Frame
Change from baseline through study completion, an average of 7 months.
Title
Change in the Berg Balance Scale
Description
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. The range of this scale is 0-56 with a larger number representing a better score.
Time Frame
Change from baseline through study completion, an average of 7 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Berg Balance Scale < 42 Self-selected 10 meter gait speed < 0.8 m/s Diagnosis of unilateral stroke > 2 months < 4 months post-stroke Able to ambulate at least 10 feet with maximum 1 person assist Medically stable Exclusion Criteria: Presence of neurological condition other than stroke Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living) Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10 degrees, knee flexion ROM < 90 degrees, hip flexion contracture > 25 degrees, and ankle plantar flexion contracture > 15 degrees) Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest Pain upon ambulation Receiving physical therapy services for mobility and/or gait Living in a skilled nursing facility Any MRI contraindication, including but not limited to the presence of metal, MR sensitive implanted medical devices, or claustrophobia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorian K Rose, PhD MS BS
Phone
(352) 273-8307
Email
Dorian.Rose@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorian Kay Rose, PhD MS BS
Organizational Affiliation
North Florida/South Georgia Veterans Health System, Gainesville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorian K Rose, PhD MS BS
Phone
(352) 273-8307
Email
Dorian.Rose@va.gov
First Name & Middle Initial & Last Name & Degree
Dorian Kay Rose, PhD MS BS
Facility Name
Brooks Rehabilitation
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorian K Rose, PhD
Phone
352-273-8307
Email
dorian.rose@va.gov
First Name & Middle Initial & Last Name & Degree
Kayla Blunt, BS
Phone
9043458969
Email
kayla.blunt@brooksrehab.org

12. IPD Sharing Statement

Plan to Share IPD
No

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