Recruiting

Balance Training

Sponsor:

Cleveland State University

Code:

NCT03757026

Conditions

Fall

Risk Reduction

Stroke

Balance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Conventional Physical Therapy

Slip Training

Harnessed gaming

Study Details

Brief 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

Study ID

NCT03757026

Start date

Dec 12, 2018

Status verified date

Jul, 2019

Completion date

Mar, 2021

Anticipated

Primary completion date

Dec 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Stroke more than 6 months ago
  • Self-identified balance issues
  • Independent ambulation - specifically:

  • Walk at least one-half block (150') with or without standard cane or similar device
  • Stand independently for at least 30 seconds without physical assistance and without any device
  • At least ten steps without physical assistance and without any cane or similar device
  • Ability to answer two-step questions

Exclusion Criteria:

  • Allergic reaction to adhesive tapes
  • Height above 74"
  • Weight above 250 lbs
  • Medical Condition - they are not eligible if they self-identify as having any musculoskeletal, neuromuscular, cardiopulmonary, or other conditions that would limit them from participation.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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 intervention 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.

experimental: 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.

Interventions

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.

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.

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.

Primary outcome measure

  • Change from baseline Activities Specific Balance Confidence Scale (ABC) at study completion [ Time Frame: Through study completion, on average three months. ]
  • Change from baseline Mini Balance Evaluation Systems Test (MiniBEST) at study completion [ Time Frame: Through study completion, on average three months. ]
  • Change from baseline Mobility life space scale (MLSS) at study completion [ Time Frame: Through study completion, on average three months. ]
  • Change from baseline anterior, posterior, and lateral (to right and to left sides) limits of stability (LOS) scores at study completion [ Time Frame: Through study completion, on average three months. ]
  • Change from baseline Treadmill perturbation stability scores at study completion [ Time Frame: Through study completion, on average three months. ]
  • Change from baseline Falls Diary at 6 months post study completion [ Time Frame: Through 6 months post study completion, on average a total of 9 months including study duration plus 6 months post study follow-up. ]

Central Contacts and Locations

Central contacts

Ann Reinthal, PT, PhD

216-687-3576a.karas@csuohio.edu

Deborah Espy, PT, PhD

216-687-3554d.espy@csuohio.edu

Locations

Cleveland State University

Recruiting

Cleveland, Ohio, United States, 44115

Contacts

Ann Reinthal, PT, PhD

216-687-3576a.karas@csuohio.edu

Deborah Espy, PT, PhD

216-687-3554d.espy@csuohio.edu

Principal Investigator:

Ann Reinthal, PT, PhD

More Information

Sponsor

Cleveland State University

Last update posted

Jul 23, 2019

Last verified

Jul, 2019

Keywords

  • Balance Training
  • Multidirectional harness
  • Conventional balance training
  • Reactive Slip Training
  • Stroke
  • Independent ambulation
  • Physical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cleveland State University on 2019-07-23.