Comparison of Three Balance Training Protocols for Individuals Post Stroke

Summary

The purpose of this study is to compare conventional balance training to reactive training and to a novel, high intensity, harnessed training program. This study examines the impact of these interventions on fall risk and on a range of important aspects of balance including overall mobility, quality of life, and health. Participants will be 60-69 adults who had a stroke more than 6 months ago and who ambulate independently. Each participant will complete 14 sessions consisting of 4 (2 pre-, 2 post-) testing sessions and 10 intervention sessions. The pre and post testing will be the same and will consist of clinical and survey based balance and quality of life assessments and treadmill based perturbed gait testing.

The pretest will be sessions 1 and 2 will be followed by 10 intervention sessions. There will be 3 treatment groups: a conventional balance training group (PT), a reactive slip training group (Slip), and a multidirectional harness group (MHG). Participants will be randomly assigned to a group following screening and consent.

The conventional balance training group (PT) will receive 10 sessions of individualized standard of care physical therapy with the goal of improving balance and mobility. The only instructions to the PT are that the focus of the course of care should be on "balance and mobility" and that there should be 10 sessions.

The reactive slip training group (Slip) will complete a standing slip session using the current protocol of scaling slip distance and force to each individual and modulating the slip intensity across the session based on subject responses. The remaining nine intervention sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at a comfortable pace while accompanied by a researcher.

The multidirectional harness group (MHG) will use a harness that allows movement in all directions, playing selected Kinect™ active video games with varied balance demands, on multiple balance training surfaces (e.g., rocker board, foam, slider platform). Participants will wear the fall-arresting harness for all game play. Motion data will be collected during Sessions 2, 6, and 10.

For all groups, two-post-test sessions will follow the intervention sessions and will be the same as the two-pretest session. The final session will also include reviewing the participants' falls diaries and setting up procedures for contacting participants weekly or biweekly about falls.

Conditions

• Fall
• Risk Reduction
• Stroke
• Balance

Interventions

OTHER

Conventional Physical Therapy

20-22 participants randomly assigned to receive 10 sessions of balance training. Conventional balance training group (PT) will receive individualized standard of care physical therapy with the goal of improving balance and mobility during sessions 3 through 12. The only instructions to the PT are that the focus of the course of care should be on "balance and mobility" and that there should be 10 sessions total. The first visit will include an initial evaluation and limited treatment. While the remaining 9 sessions will consist of 45 minutes of PT treatment.

OTHER

Slip Training

20-22 participants randomly assigned to 1 session of slip training and 9 sessions of accompanied walking. Reactive slip training group (Slip) will complete a standing slip session using the current protocol of scaling slip distance and force to each individual and modulating the slip intensity across the session based on subject responses. Initial perturbation intensity (percent body weight and slip distance) will be based on the participant's miniBEST score and each subsequent perturbation intensity will be determined based on their response to the previous perturbations. The remaining nine interventional sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at a comfortable pace while accompanied by a researcher around Cleveland State.

OTHER

Harnessed gaming

20-22 participants randomly assigned to 10 sessions of harnessed gaming. Multidirectional harness group (MHG) will use a harness with the multidirectional OASUS frame and play selected Kinect™ active video games with varied balance demands, while standing on multiple balance training surfaces (e.g., solid floor, rocker board, foam, slider platform). Participants will wear the fall-arresting harness in the OASUS system for all game play. Motion data will be collected during gaming for Sessions 2, 6, and 10. Each game/surface will be played for about 5 to 6 minutes for 4 game/surface conditions per session. All participants will progress with the prescribed sequence of games and surfaces, progressing based on their rating of the previous three bouts of play.

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• Cleveland State University

  lead OTHER

Principal Investigators

• Ann Reinthal · Cleveland State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-12

Primary Completion

2020-12-30

Completion

2021-03-31

Countries

• United States

Study Locations