Responses to Backward Walking Training Post-Stroke

Part of paid clinical trials in Gainesville, Florida.

Sponsor
VA Office of Research and Development
Study ID
NCT04928482
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Backward Walking Training — BEHAVIORAL
    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.
  • Backward Walking Training — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 8, 2021
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 27 session group
    Participants in this arm will receive 27 sessions of backward walking training.
  • Active Comparator: 18 session group
    Participants in this arm will receive 18 sessions of backward walking training.

Primary Outcome Measure

Change in the time to complete the 10 Meter walk Test [ Time Frame: Change from baseline to end of study intervention (six or nine weeks depending on intervention arm) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesvilleFlorida32608-1135
Dorian K Rose, PhD MS BS
(352) 273-8307
Dorian Kay Rose, PhD MS BS (PRINCIPAL_INVESTIGATOR)
Brooks RehabilitationJacksonvilleFlorida32216
Dorian K Rose, PhD
352-273-8307
Kayla Blunt, BS
9043458969

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