A Novel Strategy to Decrease Fall Incidence Post-Stroke

NCT02688777 | Completed Results

• 1 other identifier: N2004-R
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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. Contributing to these costs is the incidence of falls. Falls are a costly complication for Veterans with stroke as they lead to an increased incidence of fractures, depression, and mortality. New strategies are needed to help Veterans post-stroke regain their ability to safely walk without increasing their risk of falling as well as readily identify those who are a fall risk. This study addresses both of these needs as it will 1) investigate a new treatment approach, backward walking training, to determine if it will decrease fall incidence in the first year post-stroke and 2) determine if backward walking speed early after a stroke can identify those that are at risk for future falls.

Conditions

Stroke

Keywords

Rehabilitation; Gait; Postural Balance; Exercise; Accidental Falls; Kinesiology, Applied

Outcome Measures

Primary Outcomes (1)

• Fall Incidence (Number of Falls)

  Fall incidence will be monitored using the international standards for defining and reporting falls,60 including the following definition for a fall: "A person has a fall if they end up on the ground or floor when they did not expect to. Most often a fall starts while a person is on their feet, but a fall could also start from a chair or bed. If a person ends up on the ground, either on their knees, their belly, their side, their bottom, or their back, they have had a fall." This explanation will be provided to participants and caregivers and printed on monthly calendars issued at randomization. The number of falls will be recorded on a monthly basis and then added across months to determine the number of recorded falls between baseline and 1-year post-stroke.

  Number of recorded falls between baseline and 1-year post-stroke

Secondary Outcomes (12)

• 10 Meter Walk Test

  Change between baseline and 1-year post-stroke

• 3-Meter Backward Walk Test

  Change between baseline and 1-year post-stroke

• Functional Gait Assessment

  Change between baseline and 1-year post-stroke

• Activities-Specific Balance Confidence Scale

  Change between baseline and 1-year post-stroke

• Berg Balance Scale

  Change between baseline and 1-year post-stroke

Study Arms (2)

Immediate Backward Walking Training

EXPERIMENTAL

Individuals will participate in 18 sessions of Backward Walking training immediately following baseline assessment.

Behavioral: Backward Walking Training

Delayed Backward Walking Training

ACTIVE COMPARATOR

Individuals will participate in 18 sessions of Backward Walking training at 1-year post-strokeD

Behavioral: Backward Walking Training

Interventions

Backward Walking Training BEHAVIORAL

Backward Walking Training will occur both on a treadmill and overground. In brief, BWTraining will consist of 20-30 minutes of step training with a Body Weight Support and Treadmill system (BWST), rest periods provided as warranted, with manual assistance provided by trainers, followed by 15 minutes of overground gait training. A 20-30 min period of actual stepping is the goal for the intervention sessions on the treadmill with rest periods as needed. Each training session may last up to 1 hour and 30 minutes including time for warm-up, stretching, and cool down. Participants will be fitted with a harness around their hips and torso, which will be attached to an overhead support system directly above the treadmill. From a stationary position, the treadmill belt will gradually be increased in speed with intervention trainers assisting participant to step backward with their paretic leg, their non-paretic leg (if needed) and at the hips for weight-shift.

Delayed Backward Walking Training; Immediate Backward Walking Training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• Physician approval for patient participation

You may not qualify if:

• 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
• knee flexion Range Of Motion \< 90
• hip flexion contracture \> 25
• ankle plantar flexion contracture \> 15
• Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Dr. Dorian Rose
• Organization: North Florida/South Georgia Veteran's Health System

dorian.rose@va.gov

352-376-1611

Study Officials

• Dorian Kay Rose, PhD MS BS

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 23, 2016
• Study Start: August 14, 2017
• Primary Completion: September 30, 2021
• Study Completion: February 11, 2022
• Last Updated: November 24, 2023
• Results First Posted: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)