Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Three Balance Training Protocols for Individuals Post Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03757026
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
M. Ann Reinthal, Cleveland State University

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.


Condition or disease Intervention/treatment Phase
Fall Risk Reduction Stroke Balance Other: Conventional Physical Therapy Other: Slip Training Other: Harnessed gaming Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balance Training Post Stroke: Intense Harnessed Multidirectional Training as Compared to Reactive and Conventional Protocols
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
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.
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 Name: Balance training

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.
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 Name: Reactive slip training

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.
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.
Other Name: Multidirectional harness group




Primary Outcome Measures :
  1. Change from baseline Activities Specific Balance Confidence Scale (ABC) at study completion [ Time Frame: Through study completion, on average three months. ]
    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)

  2. Change from baseline Mini Balance Evaluation Systems Test (MiniBEST) at study completion [ Time Frame: Through study completion, on average three months. ]
    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.

  3. Change from baseline Mobility life space scale (MLSS) at study completion [ Time Frame: Through study completion, on average three months. ]
    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.

  4. 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. ]
    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.

  5. Change from baseline Treadmill perturbation stability scores at study completion [ Time Frame: Through study completion, on average three months. ]
    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).

  6. 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. ]
    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).


Secondary Outcome Measures :
  1. Change from baseline Fugl Meyer Lower Extremity Sensory and Movement testing (FM LE) at study completion [ Time Frame: Through study completion, on average three months. ]
    Evaluates and measures recovery in post-stroke hemiplegic patients. This outcome measure assesses sensorimotor function through the lower extremity. Items are scored on a 3-point ordinal scale.

  2. Change from baseline Monofilament sensory testing (5.07 monofilament testing of foot and ankle) at study completion [ Time Frame: Through study completion, on average three months. ]
    Using 5.07 monofilament, test the bottom and top of the foot below in locations pictured, including the medial and lateral malleolus and the anterior ankle at the mid-position between the two malleoli. While holding the handle, push the monofilament at a 90-degree angle against the skin until the monofilament bows. Hold for 1.5 seconds. Record with a check mark (√) if sensation intact and an X to denote no sensation at that point.

  3. Change from baseline Five times sit-to-stand test (5XSTS) at study completion [ Time Frame: Through study completion, on average three months. ]
    Patient sits with arms folded across chest and with back against the chair. With patients who have had a stroke, it is permissible to have the impaired arm at the side or in a sling.They must stand fully between repetitions of the test and not to touch the back of the chair during each repetition. They will stand up full 5 times. Documentation of speed and assist level (CGA, supervision, Mod I, or I) will be recorded.

  4. Change from baseline Stroke Impact Scale (SIS) at study completion [ Time Frame: Through study completion, on average three months. ]
    The Stroke Impact Scale (SIS) is a questionnaire that evaluates how a stroke has impacted the participant's health and life. The SIS has eight sections measuring self-perceived strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand use, and work/leisure participation. There are multiple questions in each section, with each question rated from 1 to 5 in terms of activity difficulty, activity frequency, or strength. Summary scores are generated for each of the 8 sections. The scoring uses a transformed scale [(actual raw score - lowest possible raw score) /possible raw score range] x 100) and some items must be reverse scored. Scores range from 0-100% for each section with 100% indicating the highest level of function. There is also a final ninth section rating percent overall self-perceived recovery from the stroke with 100% being fully recovered.

  5. Change from baseline Berg Balance Scale (BBS) at study completion [ Time Frame: Through study completion, on average three months. ]
    The BBS measures balance ability (static and dynamic) among older adults. The BBS is a qualitative measure that assesses balance through performing functional activities. Each item is scored on a 5-point scale, ranging from 0 to 4, zero indicating the lowest level of function and 4 the highest level of function.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757026


Contacts
Layout table for location contacts
Contact: Ann Reinthal, PT, PhD 216-687-3576 a.karas@csuohio.edu
Contact: Deborah Espy, PT, PhD 216-687-3554 d.espy@csuohio.edu

Locations
Layout table for location information
United States, Ohio
Cleveland State University Recruiting
Cleveland, Ohio, United States, 44115
Contact: Ann Reinthal, PT, PhD    216-687-3576    a.karas@csuohio.edu   
Contact: Deborah Espy, PT, PhD    216-687-3554    d.espy@csuohio.edu   
Principal Investigator: Ann Reinthal, PT, PhD         
Sub-Investigator: Deborah Espy, PT, PhD         
Sponsors and Collaborators
Cleveland State University
American Heart Association
Investigators
Layout table for investigator information
Principal Investigator: Ann Reinthal Cleveland State University

Layout table for additonal information
Responsible Party: M. Ann Reinthal, Associate Professor, Cleveland State University
ClinicalTrials.gov Identifier: NCT03757026     History of Changes
Other Study ID Numbers: IRB-FY2019-17
18IPA34170316 ( Other Grant/Funding Number: American Heart Association )
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M. Ann Reinthal, Cleveland State University:
Balance Training
Multidirectional harness
Conventional balance training
Reactive Slip Training
Stroke
Independent ambulation
Physical therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases