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| Name | Class |
|---|---|
| The Gertner Institute | OTHER |
| ReAbility Online | OTHER |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-motion rehabilitation system | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-motion rehabilitation system | Device | 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. |
| 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 |
| 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 |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Allen Brown, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |