Evaluation of Robot Assisted Neuro-Rehabilitation "SRT3"

Completed

Phase 1/2 Results

Trial Description

Robotic devices are capable of providing therapy to the arm of patients with weakness due to stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of the weak arm for real life situations often remains limited. The goal of this study is to determine the best way to use robotic devices and functional task training to improve the use of the stroke affected arm for real life situations. A secondary goal of this study is to determine how or if specific areas of the brain are excited before and after training. The use of a safe and painless magnetic field directed at the brain called transcranial magnetic stimulation (TMS) will be used at set intervals to gain a better understanding of brain activity during recovery.

Detailed Description

After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinematic and strength testing will be performed with the rehabilitation robots in measurement mode. The rehabilitation robot modules include the wrist, the planar (shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are cleared for marketing as a registered medical device under U.S. FDA regulations and are listed with the FDA both as an evaluation devices and as therapy devices.
Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of robot therapy combined with transition to task therapy. Study interventions will occur 3 times a week for 12 weeks. Robot therapy will consist of a progression through three robot modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will be sequential with four weeks of training on each robotic device. All participants will complete a motor activity log during this intervention phase.
TMS is being used for physiological measurement and evaluations will be conducted with each participant at baseline, week one, week five, eight, and final. TMS will also occur during the follow-up on week twenty-four.
Disability and depression questionnaires, upper extremity measures and evaluations of functional performance will be conducted during the study at baseline, and at training completion (visit 36). Patients will return twelve weeks after the end of the training period to determine whether any observed improvements persist.

Conditions

Interventions

  • Upper extremity exercise Behavioral
    Other Names: Transition to task therapy
    Intervention Desc: Task specific practice of functional activities using the hemiparetic arm
    ARM 1: Kind: Experimental
    Label: 1
    Description: 12 weeks of task specific practice combined with robotic therapy
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: 12 weeks of task specific practice combined with robotic therapy
  • Upper extremity robotic exercise Behavioral
    Intervention Desc: Robot therapy consisting of a progression through three robot modules: wrist, planar, and alternating wrist and planar robot. The progression will be sequential with four weeks of training on each robotic device.
    ARM 1: Kind: Experimental
    Label: 2
    Description: 12 weeks of robotic therapy
    ARM 2: Kind: Experimental
    Label: Arm 2
    Description: 12 weeks of robotic therapy
  • Robot Therapy Behavioral
    Other Names: Upper extremity (UE) robot-assisted exercise
    Intervention Desc: Robot assisted arm exercise for 60 minutes progressing each month through three robot modules: wrist, planar, and alternating sessions on the wrist and planar robot 3x/week for 12 weeks.
    ARM 1: Kind: Experimental
    Label: Robot Therapy
    Description: 12 weeks of robotic therapy
  • Transition to Task Training Behavioral
    Intervention Desc: Robot therapy as described for 45 minutes and 15 minutes of task specific arm exercise using the hemiparetic arm 3x/week for 12 weeks.
    ARM 1: Kind: Experimental
    Label: Transition to Task Training
    Description: 12 weeks of task specific practice combined with robotic therapy

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Upper Extremity Impairment as measured by the Fugl-Meyer Motor Assessment week 12 No
Secondary Motor Cortex Excitability via Trancranial Magnetic Stimulation (TMS) week 12 No
Secondary Motor Cortex Excitability via Transcranial Magnetic Stimulation (TMS) week 12 No
Primary Fugl-Meyer Motor Upper Extremity Assessment Baseline, 12 week, and 24 week retention No
Secondary Wolf Motor Function Test (WMFT) Baseline, 12 week, and 24 week retention No
Secondary Stroke Impact Scale: Hand Subscale Baseline, 12 week and 24 week retention No

Sponsors