Evaluation of a Tele-Rehabilitation Service Program

Mayo Clinic10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Paresis

Interventions

Tele-motion rehabilitation systemDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Satisfaction Questionnaire

Clinician and participant satisfaction questionnaire

Time frame: 3 months

System Usability Scale

Clinician and participant usability questionnaire

Time frame: 3 months

Qualitative measure of technology/communications problems

Self report text of problems and difficulty with experimental technology and communication from participants and clinicians

Time frame: 3 months

Secondary Outcomes

Upper limb (shoulder, elbow) range of motion

Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer

Time frame: Baseline and at 3 months

Fugl- Meyer Scale

Fugl- Meyer Assessment for the participant's upper limb

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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