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Evaluation of a Tele-Rehabilitation Service Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577276
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : June 4, 2018
Sponsor:
Collaborators:
The Gertner Institute
ReAbility Online
Information provided by (Responsible Party):
Allen Brown, Mayo Clinic

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?

Condition or disease Intervention/treatment Phase
Stroke Paresis Device: Tele-motion rehabilitation system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program
Actual Study Start Date : November 6, 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Tele-motion rehabilitation system
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
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.
Other Name: Microsoft XB1 Kinect Sensor




Primary Outcome Measures :
  1. Satisfaction Questionnaire [ Time Frame: 3 months ]
    Clinician and participant satisfaction questionnaire

  2. System Usability Scale [ Time Frame: 3 months ]
    Clinician and participant usability questionnaire

  3. Qualitative measure of technology/communications problems [ Time Frame: 3 months ]
    Self report text of problems and difficulty with experimental technology and communication from participants and clinicians


Secondary Outcome Measures :
  1. Upper limb (shoulder, elbow) range of motion [ Time Frame: Baseline and at 3 months ]
    Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer

  2. Fugl- Meyer Scale [ Time Frame: Baseline and at 3 months ]
    Fugl- Meyer Assessment for the participant's upper limb

  3. Motor Activity Log (MAL) [ Time Frame: Baseline and at 3 months ]
    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.

  4. Measures from the ReAbility Online system of participant and clinician activity [ Time Frame: Weekly through 3-month study period ]
    Time of practice by participant as measured by the ReAbility Online system

  5. Task performance scores [ Time Frame: Weekly through 3-month study period ]
    Participant task performance scores as measured by the ReAbility Online system

  6. Upper limb range of motion [ Time Frame: Weekly through 3-month study period ]
    Upper limb range of motion of participant as measured by the ReAbility Online system

  7. Number of compensatory movements [ Time Frame: Weekly through 3-month study period ]
    Number of compensatory movements as measured by the ReAbility Online system

  8. Time online [ Time Frame: Weekly through 3-month study period ]
    Time online of participant and clinician as measured by the ReAbility Online system



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577276


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
The Gertner Institute
ReAbility Online
Investigators
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Principal Investigator: Allen Brown, MD Mayo Clinic
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Responsible Party: Allen Brown, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02577276    
Other Study ID Numbers: 15-006308
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allen Brown, Mayo Clinic:
stroke
remote monitoring
hemiparesis
Additional relevant MeSH terms:
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Paresis
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms