Robot-aided Proprioceptive Rehabilitation Training

Recruiting

Phase N/A Results N/A

Trial Description

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).

Conditions

Interventions

  • Usual care Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Usual care
    Description: This arm will receive what participants have been receiving from their healthcare providers. It may range from no treatment to various sessions of occupational and physical therapy at home, day rehabilitation, or outpatient visits.
  • Proprioceptive training Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Proprioceptive training
    Description: This arm will receive specialized robot-aided proprioceptive training of the wrist next to usual care.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Joint position sense acuity of the wrist (just-noticeable-difference threshold) For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7. No
Secondary Root-mean-square tracing error as a measure of movement accuracy For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7. No
Secondary Movement time For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7. No
Secondary Jerk cost as a measure of movement smoothness For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7. No
Secondary Fugl-Meyer Assessment score For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7. No
Secondary Nottingham Sensory Assessment score For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7. No
Secondary Canadian Occupational Performance Measure (COPM) For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7. No
Secondary Mean somatosensory-evoked potential (SEP) latencies for N20 and N30 For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7. No
Secondary Peak-to-peak amplitude of motor-evoked potential (MEP) For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7. No

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