Robot-aided Proprioceptive Rehabilitation Training
Condition: Stroke; Peripheral Sensory Neuropathy
Study type: Interventional

Summary: 
      This study investigates the effect of a robot-aided 2-day proprioceptive training of the
      wrist on the proprioceptive and motor function of the wrist/hand complex in patients with
      proprioceptive impairment. The wrist proprioceptive training consists of active movement
      training with augmented haptic and vibro-tactile feedback provided by a patented wrist
      robotic system (US Serial No. 62/136,065). This study protocol can be applied to a variety of
      clinical and non-clinical populations. The purpose of this study is to obtain preliminary
      data on the effectiveness of the proprioceptive training in subjects with cortical stroke or
      peripheral sensory neuropathy.
    

Detailed description: 
      This protocol seeks to improve proprioceptive-motor function. Proprioception refers to the
      perception of limb position or motion and the orientation of one's body in space. Numerous
      medical conditions with motor symptoms are also associated with proprioceptive loss, such as
      osteoarthritis, Parkinson's disease, peripheral sensory neuropathy, stroke, and developmental
      coordination disorder.

      However, therapies to improve proprioceptive function in these populations are either
      non-existent or very limited in scope although it is established that proprioceptive
      impairments severely degrade motor function. The proposed protocol focuses on proprioception
      for fine motor function of the hand/wrist joint complex, because hand/wrist motor control is
      highly important for activities of daily living.

      The specific aims are to determine if a 2-day wrist proprioceptive training:

        1. improves limb position sense acuity,

        2. improves the spatial precision of wrist/hand motor tasks,

        3. increases the efficiency of performing such motor tasks,

        4. is associated with neural changes in cortical processing as measured by short-latency
           somatosensory evoke potentials (SEP) and motor evoked potentials (MEP) using
           transcranial magnetic stimulation.

      The study follows a crossover design with two arms and two groups. Time frame for the
      completion of the study is up to 7 days depending on the start day of the week (Monday
      through Friday). No testing will occur on the weekend.

      Group 1 will have the following time frame: Day 1: pre-test (approx. 3 hrs.) and training
      intervention (approx. 30 min.). Day 2: training intervention (approx. 30 min.) and post-test
      1 (approx. 3 hrs.). Days 3-6: Usual care (min. of 2 days required). Days 5-7: Post-test 2
      (depending on the start day of the week, it is either Day 5,6, or 7).

      Group 2 will have the following time frame: Day 1: pre-test 1 (approx. 3 hrs.). Days 2-4:
      Usual care (min. of 2 days required). Days 4-6: pre-test 2 (approx. 3 hrs.) and training
      intervention (approx. 30 min.). Days 5-7: Training intervention and post-test 1 (depending on
      the start day of the week, it is either Day 5,6, or 7).
    

Intervention name(s): Proprioceptive training; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training includes a virtual balance board and center-out task. Small vibratory motors placed on forearms provide vibro-tactile movement feedback (VTF). During familiarization participants learn to associate VTF with wrist movement and visual feedback. Vision is occluded after this phase. In the virtual balance board task participants use wrist motion to roll a ball to a target on the board. VTF indicates the desired movement direction and ball velocity. The center-out task involves wrist motion to control a cursor to reach a target. The wrist robot delivers an assistive force towards the target. VTF signals magnitude and direction of the cursor deviating away from the desired path.; Usual care refers to care that participants receive through their healthcare providers. It may range from no treatment to various sessions of occupational and physical therapy received at in- or outpatient rehabilitation clinics or at home.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment