Long-term Telerehabilitation for Patients With Stroke
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|ClinicalTrials.gov Identifier: NCT03460587|
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : October 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases||Device: Telerehabilitation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Telerehabilitation for Patients With Stroke|
|Actual Study Start Date :||August 29, 2018|
|Actual Primary Completion Date :||March 31, 2019|
|Actual Study Completion Date :||March 31, 2019|
Experimental: Home-based Telerehabilitation
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.
- Fugl-Meyer arm motor scale [ Time Frame: 90 days ]measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment
- Stroke Prevention Knowledge [ Time Frame: 90 days ]knowledge about stroke prevention, scores range from 0 to 30 with higher numbers reflecting greater stroke prevention knowledge
- Fugl-Meyer leg motor scale [ Time Frame: 90 days ]measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment
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): NCT03460587
|United States, California|
|University of California, Irvine|
|Irvine, California, United States, 92697|
|Principal Investigator:||Steven Cramer, MD||UC Irvine|