Back to results

Long-term Telerehabilitation for Patients With Stroke

Primary Purpose

Stroke, Cerebrovascular Disorders, Brain Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Telerehabilitation

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 years at the time of randomization
Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage or subarachnoid hemorrhage, and with any time of stroke onset prior to randomization
Arm motor Fugl Meyer score of 28-66; if Arm motor Fugl Meyer score> 59, must also have Box & Blocks on affected side >25% lower
Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the first visit
Informed consent signed by the subject
Behavioral contract signed by the subject

Exclusion Criteria:

A major, active, coexistent neurological or psychiatric disease, including alcoholism or dementia
A diagnosis (apart from the index stroke) that substantially affects paretic arm function
A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
Severe depression, defined as Geriatric Depression Scale Score >11
Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22; note that this exclusion criteria can be waived at the discretion of the study PI, e.g., for aphasia
Deficits in communication that interfere with reasonable study participation
Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
Life expectancy < 6 months
Receipt of Botox to arms, legs, or trunk in the preceding 6 months, or expectation that Botox will be administered to the arm, leg, or trunk prior to completion of participation in this study
Unable to successfully perform all 3 of the rehabilitation exercise test examples
Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy, or expectation that subject will be unable to participate in study visits
Concurrent enrollment in another investigational study
Non-English speaking, such that subject does not speak sufficient English to comply with study procedures
Expectation that subject will not have a single domicile address during the 12 weeks of therapy, within 75 miles of the central study site
Note that the presence of wireless home internet connectivity is not an exclusion criterion, but preference may be given to enrollees who do have wireless home internet connectivity because this will enable testing of study hypotheses.

Sites / Locations

University of California, Irvine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-based Telerehabilitation

Arm Description

Home-based Telerehabilitation

Outcomes

Primary Outcome Measures

Fugl-Meyer Arm Motor Scale

measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment

Secondary Outcome Measures

Fugl-Meyer Leg Motor Scale

measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment

Full Information

NCT ID

NCT03460587

First Posted

February 28, 2018

Last Updated

November 22, 2020

Sponsor

University of California, Irvine

1. Study Identification

Unique Protocol Identification Number

NCT03460587

Brief Title

Long-term Telerehabilitation for Patients With Stroke

Official Title

Long-term Telerehabilitation for Patients With Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

August 29, 2018 (Actual)

Primary Completion Date

March 31, 2019 (Actual)

Study Completion Date

March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the current protocol is to study 40 patients, each for 12 weeks, to address hypotheses related to the ability of a telerehabilitation system to (a) improve motor status and disability, (b) collect various forms of patient data from the home, (c) improve risk factor knowledge and control, and (d) assess patient compliance with home-based telerehabilitation. Patients who have returned to their home after stroke will be provided with a telehealth system and be asked to use it 6 days/week for 12 weeks, during which time subjects will use this system for daily rehabilitation therapy, assessments, and education--all on one platform.

Detailed Description

Stroke is perennially one of the leading causes of human disability. Stroke is truly a chronic disease, with survivors living for years or decades after the event. Increasing evidence describes years of steady decline in several health measures for stroke survivors. Many factors contribute to this, including further strokes, uncontrolled risk factors, development of late complications of stroke, and limited access to rehabilitation therapy. New approaches are needed that address the many needs of stroke survivors, efficiently and in aggregate. Emerging telehealth technologies have high potential to address this major unmet need, but substantial innovation will be needed. The long-term goal is to establish a telehealth platform to treat chronic stroke. A telehealth system will be delivered to enrollee's home. Patients will be asked to interact with their system daily (at least 6 days/wk) for 12 weeks. For 3 times per week, during the first 2 weeks, and then 1 time per week thereafter, a study therapist or research assistant in the lab will use the telehealth system to have a videoconference with the subject, to answer questions, provide feedback, review progress, and make any changes needed in the therapy plan. Study personnel will monitor usage statistics and performance measures for all systems. A key strategy is to measure in parallel, patient behaviors in three categories of health issues central to chronic stroke: (1) medical management issues including risk factor knowledge and control, (2) disability issues including motor function, and (3) psychological issues including depression and anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Home-based Telerehabilitation

Arm Type

Experimental

Arm Description

Home-based Telerehabilitation

Intervention Type

Device

Intervention Name(s)

Telerehabilitation

Intervention Description

The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.

Primary Outcome Measure Information:

Title

Fugl-Meyer Arm Motor Scale

Description

measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Fugl-Meyer Leg Motor Scale

Description

measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years at the time of randomization Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage or subarachnoid hemorrhage, and with any time of stroke onset prior to randomization Arm motor Fugl Meyer score of 28-66; if Arm motor Fugl Meyer score> 59, must also have Box & Blocks on affected side >25% lower Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the first visit Informed consent signed by the subject Behavioral contract signed by the subject Exclusion Criteria: A major, active, coexistent neurological or psychiatric disease, including alcoholism or dementia A diagnosis (apart from the index stroke) that substantially affects paretic arm function A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures Severe depression, defined as Geriatric Depression Scale Score >11 Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22; note that this exclusion criteria can be waived at the discretion of the study PI, e.g., for aphasia Deficits in communication that interfere with reasonable study participation Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye Life expectancy < 6 months Receipt of Botox to arms, legs, or trunk in the preceding 6 months, or expectation that Botox will be administered to the arm, leg, or trunk prior to completion of participation in this study Unable to successfully perform all 3 of the rehabilitation exercise test examples Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy, or expectation that subject will be unable to participate in study visits Concurrent enrollment in another investigational study Non-English speaking, such that subject does not speak sufficient English to comply with study procedures Expectation that subject will not have a single domicile address during the 12 weeks of therapy, within 75 miles of the central study site Note that the presence of wireless home internet connectivity is not an exclusion criterion, but preference may be given to enrollees who do have wireless home internet connectivity because this will enable testing of study hypotheses.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Cramer, MD

Organizational Affiliation

UC Irvine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Irvine

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29072556

Citation

Dodakian L, McKenzie AL, Le V, See J, Pearson-Fuhrhop K, Burke Quinlan E, Zhou RJ, Augsberger R, Tran XA, Friedman N, Reinkensmeyer DJ, Cramer SC. A Home-Based Telerehabilitation Program for Patients With Stroke. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):923-933. doi: 10.1177/1545968317733818. Epub 2017 Oct 26.

Results Reference

background

PubMed Identifier

21482550

Citation

Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10.

Results Reference

background

PubMed Identifier

10421300

Citation

Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6. doi: 10.1016/S0140-6736(98)09477-X.

Results Reference

background

PubMed Identifier

33613417

Citation

Cramer SC, Dodakian L, Le V, McKenzie A, See J, Augsburger R, Zhou RJ, Raefsky SM, Nguyen T, Vanderschelden B, Wong G, Bandak D, Nazarzai L, Dhand A, Scacchi W, Heckhausen J. A Feasibility Study of Expanded Home-Based Telerehabilitation After Stroke. Front Neurol. 2021 Feb 3;11:611453. doi: 10.3389/fneur.2020.611453. eCollection 2020.

Results Reference

derived

Learn more about this trial

Long-term Telerehabilitation for Patients With Stroke

We'll reach out to this number within 24 hrs