Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Early Phase 1

Summary: 
      aim: To examine the effect of a perturbation-based balance training on balance reaction
      characteristics in post stroke individuals.
    

Detailed description: 
      60 stroke subjects from the neurology rehabilitation unit at Loewenstein hospital will be
      randomly allocated to one of two groups: 1) perturbations based balance training 2) weight
      shifting and gait training without external perturbations (control).

      Group 1 - Perturbations based balance training Subjects will complete a perturbation based
      balance training while standing and walking on the BalanceTutor (MediTouch). Perturbation
      level will be individually adjusted and progressed according to subject's abilities.
      Progression occurs by increasing perturbation level (increase distance, velocity and
      acceleration). At each practiced level subjects will be exposed to random
      right/left/forward/backward unannounced platform translations while standing and to
      right/left perturbations (in defined events in gait cycle) while walking. In order to examine
      adaptation to repeated perturbations, kinematic data will be collected in the first session.

      Group 2 - Weight shifting and gait training Subjects will complete a balance training program
      that includes voluntary weight shifting while standing on a computerized posturography
      (NeuroCom) and walking on a treadmill. Weight shifting toward a target will be adjusted and
      progressed according to subject's abilities. Progression in difficulty level will occur by
      increasing the distance to target without changing the base of support. At each practiced
      level weight shifting will be conducted to right/left/forward/backward directions. In the
      gait part of the session, subjects will be asked to walk at their preferred treadmill walking
      speed.

      Subjects in both groups will complete 10-12 training sessions, 4-5 per week for 3 weeks. Each
      session will last 30 minutes and will include practice in standing and walking. Subject's
      activities will be documented in each session in both groups. Furthermore, in each session
      subjects will be asked to rate their perceived level of challenge on a 0-10 scale.

      Pre- and post-intervention measurements will be conducted. A follow-up measurement will be
      conducted 3-6 weeks post intervention.

      The following measurements will be administered:

      1)Compensatory balance reaction kinematic measurement:

      Compensatory balance reactions will be measured using the BalanceTutor (MediTouch). The
      BalanceTutor is a mechatronic device consisting of a computerized treadmill with a horizontal
      movable platform and an operator station. Measurements will be taken in two conditions:

      Standing. Subjects will be instructed to stand and will be exposed to random unexpected
      platform translations. The platform translations will be increased systematically and
      controlled. The increases in platform translation will be adjusted by the examiner to the
      subject's ability to recover from perturbations. Participants will be asked to respond in a
      "natural" manner to perturbations.

      Walking. Subjects will be instructed to walk comfortably (self-paced) on the treadmill, and
      will be exposed to random unexpected platform translations. The platform translations will be
      increased systematically and controlled and will be adjusted by the examiner to the subject's
      ability to recover from perturbations. Compensatory balance reaction characteristics
      (reaction time, swing time, compensatory step time, step length etc.) will be collected
      through a three-dimensional motion analysis system. During examination subjects will wear a
      loose safety harness that will prevent a fall and yet allow the execution of balance recovery
      reactions.

      In addition, clinical measures will be used: Berg Balance Scale, 6 minute walk test, 10 meter
      walk test, the Fugl-Meyer test for motor recovery after stroke and the ABC
      (Activities-specific Balance Confidence) scale. Normalized lesion data will be computed using
      the ABLE module within MEDx software (Medical Numerics).
    

Intervention name(s): Stroke Subjects Perturbation-Based Balance Training; Stroke Subjects Weight Shifting and Gait training
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment