Evaluation of a Tele-Rehabilitation Service Program
Primary Purpose
Stroke, Paresis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-motion rehabilitation system
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, remote monitoring, hemiparesis
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tele-motion rehabilitation system
Arm Description
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.
Outcomes
Primary Outcome Measures
Satisfaction Questionnaire
Clinician and participant satisfaction questionnaire
System Usability Scale
Clinician and participant usability questionnaire
Qualitative measure of technology/communications problems
Self report text of problems and difficulty with experimental technology and communication from participants and clinicians
Secondary Outcome Measures
Upper limb (shoulder, elbow) range of motion
Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer
Fugl- Meyer Scale
Fugl- Meyer Assessment for the participant's upper limb
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.
Measures from the ReAbility Online system of participant and clinician activity
Time of practice by participant as measured by the ReAbility Online system
Task performance scores
Participant task performance scores as measured by the ReAbility Online system
Upper limb range of motion
Upper limb range of motion of participant as measured by the ReAbility Online system
Number of compensatory movements
Number of compensatory movements as measured by the ReAbility Online system
Time online
Time online of participant and clinician as measured by the ReAbility Online system
Full Information
NCT ID
NCT02577276
First Posted
October 12, 2015
Last Updated
May 31, 2018
Sponsor
Mayo Clinic
Collaborators
The Gertner Institute, ReAbility Online
1. Study Identification
Unique Protocol Identification Number
NCT02577276
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 6, 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
The Gertner Institute, ReAbility Online
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Paresis
Keywords
stroke, remote monitoring, hemiparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-motion rehabilitation system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Tele-motion rehabilitation system
Other Intervention Name(s)
Microsoft XB1 Kinect Sensor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Satisfaction Questionnaire
Description
Clinician and participant satisfaction questionnaire
Time Frame
3 months
Title
System Usability Scale
Description
Clinician and participant usability questionnaire
Time Frame
3 months
Title
Qualitative measure of technology/communications problems
Description
Self report text of problems and difficulty with experimental technology and communication from participants and clinicians
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Upper limb (shoulder, elbow) range of motion
Description
Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer
Time Frame
Baseline and at 3 months
Title
Fugl- Meyer Scale
Description
Fugl- Meyer Assessment for the participant's upper limb
Time Frame
Baseline and at 3 months
Title
Motor Activity Log (MAL)
Description
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
Title
Measures from the ReAbility Online system of participant and clinician activity
Description
Time of practice by participant as measured by the ReAbility Online system
Time Frame
Weekly through 3-month study period
Title
Task performance scores
Description
Participant task performance scores as measured by the ReAbility Online system
Time Frame
Weekly through 3-month study period
Title
Upper limb range of motion
Description
Upper limb range of motion of participant as measured by the ReAbility Online system
Time Frame
Weekly through 3-month study period
Title
Number of compensatory movements
Description
Number of compensatory movements as measured by the ReAbility Online system
Time Frame
Weekly through 3-month study period
Title
Time online
Description
Time online of participant and clinician as measured by the ReAbility Online system
Time Frame
Weekly through 3-month study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Brown, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of a Tele-Rehabilitation Service Program
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