Clinical trial NCT02577276: Evaluation of a Tele-Rehabilitation Service Program
Official title: Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Paresis
Keywords: stroke
remote monitoring
hemiparesis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: The Gertner Institute
name: ReAbility Online
First posted: 2015-10-16
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction Questionnaire
timeFrame: 3 months
measure: System Usability Scale
timeFrame: 3 months
measure: Qualitative measure of technology/communications problems
timeFrame: 3 months
Secondary outcomes:
measure: Upper limb (shoulder, elbow) range of motion
timeFrame: Baseline and at 3 months
measure: Fugl- Meyer Scale
timeFrame: Baseline and at 3 months
measure: Motor Activity Log (MAL)
timeFrame: Baseline and at 3 months
measure: Measures from the ReAbility Online system of participant and clinician activity
timeFrame: Weekly through 3-month study period
measure: Task performance scores
timeFrame: Weekly through 3-month study period
measure: Upper limb range of motion
timeFrame: Weekly through 3-month study period
measure: Number of compensatory movements
timeFrame: Weekly through 3-month study period
measure: Time online
timeFrame: Weekly through 3-month study period
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Allen Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: