Comparison of Three Balance Training Protocols for Individuals Post Stroke

This study compares conventional balance training to a reactive slip protocol and novel, high
intensity, harnessed balance training using video gaming. It examines the impact of these
three interventions on fall risk and on aspects of balance including overall mobility,
quality of life and community participation. The study includes 60-69 adults who had a stroke
more than 6 months ago and who walk independently. Participants will complete 14 sessions: 4
sessions (2 pre-, 2 post-) of testing and 10 intervention sessions. There will be one to two
sessions per week depending on scheduling and participant preference.

The first session will begin with screening and the consent process after which participants
will be randomly assigned to one of the following three groups of 20-22 participants each:
conventional balance training (PT), reactive slip training (Slip), and multi-directional
harnessed gaming training (MHG). The first individual entering the study will be randomly
assigned to one of the three groups, the next person will be randomly assigned to one of the
two remaining groups, and the third person will be placed in the remaining group. This
process will be repeated with the next group of three individuals entering the study, and so
on. Approximately midway through the study, researchers will assess group mix for impairment
severity levels and adjust if necessary. All 14 sessions are outlined below including
descriptions of testing and intervention procedures.

During session one, the screening, consent and randomization process will be followed by the
clinical testing, falls history and falls diary initiation, then scheduling of subsequent
visits. Participants will be questioned as to any falls within the last 12 months, and if any
- how long ago for each fall and the circumstances of and any injuries from the fall as they
recall them. The falls diary will be explained to the participants and participants will be
asked to keep it during the weeks of the 14 sessions and for 6 months afterwards. The
stability (RPS) scale will be explained to the participants and remaining clinical testing
will be administered including the Mini-Balance Evaluation Systems Test (miniBEST). The
limits of stability testing (LOS), including the reactive perturbation testing portion of the
miniBEST will be performed with motion capture. If time, participant scheduling, and
participant tolerance for activity permit, the LOS testing will be done at the second
pre-test session because this will allow motion marker placement for one session rather than
two, saving the participant time. If timing or participant activity tolerance do not allow,
the LOS testing will be performed, with motion capture, at the first pre-test session.

The second session will continue the pre-test portion of the protocol with treadmill
perturbation testing and LOS testing. All participants will be supported in a fall-arresting
harness for all treadmill perturbation testing. First, the treadmill will be used to measure
the participant's normal then fast walking speeds. For perturbations, the treadmill will be
run at the participant's determined normal walking speed. It will randomly accelerate at
mid-stance of the hemiparetic foot, then return to its usual speed. The participant will be
asked to try to maintain his/her balance and continue walking as before, but that if the
participant needs to stop, the investigator will halt the treadmill and provide a rest break.
After each perturbation, the participant will be asked to score it on the RPS scale.
Throughout all of the treadmill perturbation testing force, motion, and load cell data will
be recorded and vital signs will be monitored consistent with Physical Therapy and exercise
standards.

There will be up to 18 perturbations. The 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 determined based on the participant's response to
the previous perturbations: three consecutive falls (>30% of participant's body weight as
measured by load cell) leads to a decrease in perturbation intensity; three consecutive
recoveries (<5%of participant's body weight as measured by load cell) leads to an increase in
perturbation intensity; and if the three previous perturbations were mixed (some combination
of falls, recoveries, and harness assists) the perturbation will be unchanged. The outcome of
each trial (fall, recovery, or harness assist) will be recorded.

After pretesting, 10 intervention sessions will begin based on group assignment, as described
above. The 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. This will be completed by an experienced community physical therapist who will be
blinded to the other groups' activities and to all pre-testing results. The first visit will
have approximately 60 minutes allotted for the initial evaluation and limited treatment while
the remaining 9 sessions will consist of 45 minutes of PT treatment. 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 investigators will be blinded to the specifics of the
individual treatments provided by the PT(s).

The reactive slip training group (Slip) will complete one 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 participant responses. To match intervention time
to the other two groups, the remaining 9 sessions will involve 45 minutes of supervised
walking with vital sign and distance monitoring, and rest as necessary.

All participants will use a full-body, fall-arresting harness throughout all slip testing.
All participants will be informed that during the experimental procedures the Slip Trainer
platform, on which they are standing, may move suddenly and unexpectedly under their feet.
The participants will be asked to react as naturally as possible to the perturbation. The
participants will also be informed that if they are unable to catch themselves, the full-body
safety harness they will be wearing will prevent a fall from occurring. Participants will be
reminded that they may request a rest break at any time. Participants will be guarded by an
investigator (both licensed Physical Therapists) or by a Student PT supervised by an
investigator.

The Slip Trainer is a low platform on rollers which allow only anterior-posterior
(forward-backward) slips, not side to side. Participants will stand quietly on the trainer
and slips will be induced by the (randomly timed and unannounced) release of weights from a
designated height, causing the weights to fall and the platform to be pulled backward or
forward approximately 15 - 30 centimeters. The amount of weight released will range from
15-40% of the participant's body weight. Up to 17 slips will be induced. The participants
will self-rate their stability during the slip with the RPS immediately after each slip
recovery. Motion, load cell and outcomes data will be collected throughout slip testing.
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 the participant's response to the previous perturbations. If this algorithm leads to
the perturbations being reduced below 5% and 5 cm or above 40% and 30 cm, the trials will be
stopped.

The remaining nine intervention sessions will consist of accompanied walking for up to 45
minutes. Participants will come to Cleveland State University and will walk at a comfortable
pace while accompanied by a researcher in the areas in or adjacent to the Health Sciences
spaces. Researchers will monitor the participants' vital signs as indicated and in the manner
consistent with standard PT/exercise practice. Participants may request rest breaks as
needed. The researcher will record the distances walked, the rests taken, and the vital signs
as taken.

The multidirectional harness group (MHG) will use a harness with the Open Area Support System
(OASUS) multidirectional harness framework 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. This harness allows participants to move
freely in any direction except it limits their vertical descent to a pre-set height. This
will be adjusted to a height that allows the participants to touch the floor or support
surface with only their feet when fully suspended in the harness in any direction; no other
body part will be able to reach the ground. This will be re-adjusted each time the
participant changes the playing surface.

Initial game and training surface combinations as well as subsequent difficulty levels and
training conditions will be chosen using a progression algorithm in conjunction with the Rate
of Perceived Stability (RPS). Motion data will be collected during gaming for Sessions 2, 6,
and 10. RPS scores will be collected during and immediately after all gaming sessions.
Participants are able to use rest breaks and will be monitored throughout all sessions
consistent with standard physical therapy/exercise practice. At the first session of MHG,
participants will be introduced to each game and given time to practice playing that game
until they feel comfortable with each game. All participants will progress with the
prescribed sequence of games and surfaces, progressing based on their rating of the previous
three bouts of play.

Two post-test sessions will follow the 10 intervention sessions. These will be equivalent to
the two-pretest session above with the treadmill testing at session 13, LOS testing at either
session 13 or 14, and the remaining clinical testing and follow up at session 14. All
participants will be reminded of previous protocols/instructions completed in their pretest
sessions. The 14th and final session will also include reviewing the participants' falls
diaries and setting up procedures for contacting participants weekly or biweekly about falls.
The participant will have a chance to ask any questions about the overall study and the
payment forms will be signed.

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.