Rehab CARES: In USA: Clinical Trial

The Aim of this study is to validate community-based use of the haptic robot gym. We will test the safety of the haptic robot gym in a community-based rehabilitation setting.

Milestones are 1) to quantify the safety of the system in terms of adverse events frequency and characteristics, 2) to quantify the feasibility of the system in terms of therapeutic benefit and motivational potential. User feedback will help refine designs. Primary outcome variable(s) The key measures will be used to evaluate outcomes. A therapist will assess motor impairment, cognition, and quality of life. The primary measures are chosen to evaluate the robots impact on major ICF domains: motor control, arm and hand activities, and participation (quality of life) and on motivation including enjoyment and engagement, The primary outcome measures are a. Upper Extremity Fugl-Meyer Assessment (UE-FM) b. Box and Block (BnB) Test
c. NIH Toolbox 9-Hole Pegboard Dexterity Test d. ADL function as measured by the Neuro-QoL Upper Extremity Function Fine Motor and ADL Short Form e. Quality of life as measured by the Neuro-QoL Ability to Participate in Social Role and Activities Short Form AND Neuro-QoL Satisfaction with Social Roles and Activities Short Form. f. Motivation as measured by the Self-Assessment Manikin (SAM)

FOR PHASE 2: Some of these assessments will be performed at pre, post and the 2 follow-up periods. Secondary outcome measures include a. Motor: NIH toolbox Grip Strength Test; The NIH Toolbox grip strength test and joint range of motion will be used as a secondary outcome measure to evaluate changes in grip strength after the intervention. The hand dynamometer is the most widely used tool for grip strength measurement and is considered to be the gold standard. b. Joint Range of Motion (ROM)
Cognition: MoCA, Flanker Inhibitory Control and Attention test: Cognition will be assessed using the MoCA, valid and reliable measure of cognition in the stroke population31 and the NIH Toolbox Flanker Inhibitory Control and Attention Test, which assesses the ability of the individual to focus on a task and accurately complete it, also validated in individuals with stroke. c. NIH Pain Intensity Measure: The NIH Pain Intensity Measure is a single-item measure of pain evaluating average pain in the past seven days. d. Borg Exertion Scale: The Borg Rating of Perceived exertion measures physical activity intensity level from no exertion at all to maximal exertion of effort. e. NASA TLX
f. System Usability Scale
g. Color Trails 1 and 2
h. Post-robot survey - updated attached to be asked during interviews

For this study: Some of these assessments will be performed at pre, post and the 2 follow-up periods.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All