Comparison of Three Balance Training Protocols for Individuals Post Stroke

NCT03757026 | Unknown

• 2 other identifiers: IRB-FY2019-1718IPA34170316
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Change from baseline Activities Specific Balance Confidence Scale (ABC) at study completion

  Indicates how self-confident the participants are not to lose their balance or become unsteady during specific activities like: walk around house, walk up and down stairs, pick up a slipper from the floor, etc. (Rating self-confidence from 0-100% on each of 16 items; then total score divided by 16 to give an overall self-confidence level, with 100% being fully confident on all 16 activities listed)

  Through study completion, on average three months.

• Change from baseline Mini Balance Evaluation Systems Test (MiniBEST) at study completion

  It aims to target and identify different balance control systems to identify balance deficits. The MiniBEST test is a 14-item test scored on a 3-level ordinal scale. Sections include anticipatory, reactive postural control, sensory orientation, and dynamic balance.

  Through study completion, on average three months.

• Change from baseline Mobility life space scale (MLSS) at study completion

  Questions for life-space mobility refers to 1) the level of the spatial area (bedroom, home, outside home, neighborhood, town, and beyond town) that an individual purposely moves through in daily life; 2) to the frequency of movement within a specific time in each area; and 3) the need for assistance with that movement. Scores range from 0 for someone who remains only the bedroom to up to 120 for someone who travels daily and independently out of his/her immediate community.

  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

  Standing limits of stability (LOS) are tested by having the participant lean as far as he/she can to the front, back, and each side, twice, without stepping or needing to reach out for support. Motion data will be used to calculate the participant's center of mass (COM) and base of support (BOS) during this test. Then, the percent of the distance the participant can move his/her COM towards the edge of his/her BOS will be calculated in each of the four directions.

  Through study completion, on average three months.

• Change from baseline Treadmill perturbation stability scores at study completion

  Participants will walk on the treadmill to determine normal and maximum gait speed. Walking at normal speed, at a random time at about mid-stance of the hemiparetic lower extremity, the treadmill will accelerate suddenly then return to its previous speed. Initial perturbation intensity will be based on the participant's miniBEST scores and normalized to that individual's maximum gait speed. Each subsequent perturbation intensity will be based on the participant's response to previous perturbations: 3 consecutive falls (\>30% of participant's body weight as measured by load cell) leads to a decrease in perturbation intensity; 3 consecutive recoveries (\<5%) leads to an increase in perturbation intensity; and if the 3 previous perturbations were mixed (combination of falls, recoveries, and harness assists) the perturbation will be unchanged. Each response will be recorded as a recovery, harness assist, or fall (recovery \<5%, harness assist 5%-30%, or fall \>30% of body weight).

  Through study completion, on average three months.

• Change from baseline Falls Diary at 6 months post study completion

  During the pre-testing sessions, participants will be asked verbally to describe their recall of falls they have experienced in the past 12 months, to be recorded by a researcher, and to keep a log of falls over the course of the study and follow-up period of 6 months (to be collected monthly after end of study by phone call).

  Through 6 months post study completion, on average a total of 9 months including study duration plus 6 months post study follow-up.

Secondary Outcomes (5)

• Change from baseline Fugl Meyer Lower Extremity Sensory and Movement testing (FM LE) at study completion

  Through study completion, on average three months.

• Change from baseline Monofilament sensory testing (5.07 monofilament testing of foot and ankle) at study completion

  Through study completion, on average three months.

• Change from baseline Five times sit-to-stand test (5XSTS) at study completion

  Through study completion, on average three months.

• Change from baseline Stroke Impact Scale (SIS) at study completion

  Through study completion, on average three months.

• Change from baseline Berg Balance Scale (BBS) at study completion

  Through study completion, on average three months.

Study Arms (3)

Conventional Physical Therapy

ACTIVE COMPARATOR

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: Conventional Physical Therapy

Slip training

EXPERIMENTAL

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.

Other: Slip Training

Harnessed gaming

EXPERIMENTAL

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.

Other: Harnessed gaming

Interventions

Conventional Physical Therapy OTHER

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.

Also known as: Balance training

Conventional Physical Therapy

Slip Training OTHER

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.

Also known as: Reactive slip training

Slip training

Harnessed gaming OTHER

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.

Also known as: Multidirectional harness group

Harnessed gaming

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cleveland State University: lead
• American Heart Association: collaborator

Study Sites (1)

Cleveland State University

Cleveland, Ohio, 44115, United States

RECRUITING

MeSH Terms

Conditions

Risk Reduction Behavior; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ann Reinthal

  Cleveland State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Reinthal, PT, PhD

CONTACT

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

Deborah Espy, PT, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 28, 2018
• Study Start: December 12, 2018
• Primary Completion: December 30, 2020
• Study Completion: March 1, 2021
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (1)