Evaluation of a Tele-Rehabilitation Service Program

Study Overview
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Brief Summary
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Is a unique tele-rehabilitation service directed at treating upper limb weakness due to stroke feasible to provide at Mayo Clinic and are the individuals with stroke and the clinicians providing the care satisfied with the process?

Detailed Description
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Participants will be identified from Mayo Clinic Division of Brain Rehabilitation's existing clinical practice and recruited either in person or by using a phone script. Eligible participants will have 2 in-person clinical assessments, one before the intervention and one concluding the protocol. The first clinical assessment will involve introducing and familiarizing the participant with the study procedure, demonstrating and practicing with the system, and obtaining baseline clinical measures. During this first session the participant's technical skills and home equipment capabilities will be assessed and any assistance needed for establishing the technology in their home will be determined and provided. The second clinical assessment will include acquiring post-intervention clinical and outcome measures. Intervention duration will be 3 months. During the study period, each participant will receive online treatment for up to 45 minutes (in order to have net 30 min clinical time) twice per week. During these sessions, the clinician will teach system interaction including integrating feedback, instruct in system intervention activities and assure participant competence in system use, and adjust the level of difficulty in each activity according to the participant's abilities and needs. After the first month of intervention, the participant may be given permission by the therapist to train with the system for no more than 40 minutes per day. Such self-training opportunities are in addition to the twice weekly online sessions with the therapist.

Official Title
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Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program

Conditions
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Stroke, Paresis

Intervention / Treatment
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* Device: Tele-motion rehabilitation system


Participation Criteria
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Eligibility Criteria
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Inclusion >12 months after stroke Age 21-80 years A minimum of 45 degrees of flexion in the affected shoulder Active extension of the affected elbow to 150 degrees Independent sitting balance Able to understand simple instructions Lives within a 100 mile radius and able to attend two clinical assessments at Mayo Clinic Able to install the tele-rehabilitation software with minimal remote technical support Available caregiver as needed who has basic technical understanding of computer operation i3 processor based PC; 26 monitor; Windows 7 or 8 operating system; Internet connection of at least 10Mbps. Exclusion Medical conditions that may limit physical activity at the level of low intensity cardio-vascular exercise Any contraindication related to the integrity of the musculoskeletal system Active malignancy Uncontrolled epilepsy Global aphasia Severe apraxia Severe ataxia Unilateral spatial neglect Chronic pain Pregnancy Adults lacking capacity

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-motion rehabilitation system<br>Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles. | Device: Tele-motion rehabilitation system<br>* Tele-motion rehabilitation system: Interventions include functional therapeutic exercise and real-time feedback. Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.<br>* Other names: Microsoft XB1 Kinect Sensor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction Questionnaire | Clinician and participant satisfaction questionnaire | 3 months | 
| System Usability Scale | Clinician and participant usability questionnaire | 3 months | 
| Qualitative measure of technology/communications problems | Self report text of problems and difficulty with experimental technology and communication from participants and clinicians | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb (shoulder, elbow) range of motion | Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer | Baseline and at 3 months | 
| Fugl- Meyer Scale | Fugl- Meyer Assessment for the participant's upper limb | Baseline and at 3 months | 
| Motor Activity Log (MAL) | Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks (original MAL), 28 functional tasks (MAL 28) or 14 tasks (MAL 14). Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting). Items scored on a 6-point ordinal scale. | Baseline and at 3 months | 
| Measures from the ReAbility Online system of participant and clinician activity | Time of practice by participant as measured by the ReAbility Online system | Weekly through 3-month study period | 
| Task performance scores | Participant task performance scores as measured by the ReAbility Online system | Weekly through 3-month study period | 
| Upper limb range of motion | Upper limb range of motion of participant as measured by the ReAbility Online system | Weekly through 3-month study period | 
| Number of compensatory movements | Number of compensatory movements as measured by the ReAbility Online system | Weekly through 3-month study period | 
| Time online | Time online of participant and clinician as measured by the ReAbility Online system | Weekly through 3-month study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, remote monitoring, hemiparesis