StrokeNCT02577276
Evaluation of a Tele-Rehabilitation Service Program
A study testing Tele-motion rehabilitation system in people with Stroke and Paresis, run by Mayo Clinic at 1 site in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 21 to 80 years
- What is being tested?
- Tele-motion rehabilitation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
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- 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.
Who cannot join
- 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
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- Severe ataxia
- Unilateral spatial neglect
- Chronic pain
- Pregnancy
- Adults lacking capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program
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?
Read the 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.
- Being tested
- Tele-motion rehabilitation system
- Keywords
- stroke, remote monitoring, hemiparesis
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-motion rehabilitation systemDevice
Also called Microsoft XB1 Kinect Sensor
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tele-motion rehabilitation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction Questionnaire
Clinician and participant satisfaction questionnaire
Measured: 3 months
System Usability Scale
Clinician and participant usability questionnaire
Measured: 3 months
Qualitative measure of technology/communications problems
Self report text of problems and difficulty with experimental technology and communication from participants and clinicians
Measured: 3 months
Secondary outcomes (8)
Upper limb (shoulder, elbow) range of motion
Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer
Measured: Baseline and at 3 months
Fugl- Meyer Scale
Fugl- Meyer Assessment for the participant's upper limb
Measured: 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.
Measured: 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
Measured: Weekly through 3-month study period
Task performance scores
Participant task performance scores as measured by the ReAbility Online system
Measured: Weekly through 3-month study period
Upper limb range of motion
Upper limb range of motion of participant as measured by the ReAbility Online system
Measured: Weekly through 3-month study period
Number of compensatory movements
Number of compensatory movements as measured by the ReAbility Online system
Measured: Weekly through 3-month study period
Time online
Time online of participant and clinician as measured by the ReAbility Online system
Measured: Weekly through 3-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start6 Nov 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- The Gertner Institute, ReAbility Online
- Responsible party
- Principal investigator, Allen Brown, Mayo Clinic
- Investigators
- Allen Brown, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577276
- Sponsor's protocol ID
- 15-006308
- Status last verified
- May 2018
- First submitted
- 12 Oct 2015
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program
- ClinicalTrials.gov ID
- NCT02577276
- Acronym / sponsor ID
- 15-006308
- Keywords
- stroke, remote monitoring, hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- The Gertner Institute, ReAbility Online
- Study start
- 6 Nov 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele-motion rehabilitation system | Experimental | Device: Tele-motion rehabilitation systemClinicians 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- >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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-motion rehabilitation systemAlso: Microsoft XB1 Kinect SensorTele-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. | Device | Tele-motion rehabilitation system |
Primary outcome
Satisfaction Questionnaire
Time frame: 3 months
Clinician and participant satisfaction questionnaire
System Usability Scale
Time frame: 3 months
Clinician and participant usability questionnaire
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
8 secondary outcomes
Upper limb (shoulder, elbow) range of motion
Time frame: Baseline and at 3 months
Fugl- Meyer Scale
Time frame: Baseline and at 3 months
Motor Activity Log (MAL)
Time frame: Baseline and at 3 months
Measures from the ReAbility Online system of participant and clinician activity
Time frame: Weekly through 3-month study period
Task performance scores
Time frame: Weekly through 3-month study period
Upper limb range of motion
Time frame: Weekly through 3-month study period
Number of compensatory movements
Time frame: Weekly through 3-month study period
Time online
Time frame: Weekly through 3-month study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen Brown, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-motion rehabilitation system in people with Stroke and Paresis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction Questionnaire (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.