Evaluation of a Tele-Rehabilitation Service Program

NCT02577276 | Completed

• 1 other identifier: 15-006308
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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?

Conditions

Stroke; Paresis

Keywords

stroke; remote monitoring; hemiparesis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Upper limb (shoulder, elbow) range of motion

  Baseline and at 3 months

• Fugl- Meyer Scale

  Baseline and at 3 months

• Motor Activity Log (MAL)

  Baseline and at 3 months

• Measures from the ReAbility Online system of participant and clinician activity

  Weekly through 3-month study period

• Task performance scores

  Weekly through 3-month study period

Study Arms (1)

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.

Device: Tele-motion rehabilitation system

Interventions

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.

Also known as: Microsoft XB1 Kinect Sensor

Tele-motion rehabilitation system

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• The Gertner Institute: collaborator
• ReAbility Online: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allen Brown, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 16, 2015
• Study Start: November 6, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)