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Long-term Telerehabilitation for Patients With Stroke

Long-term Telerehabilitation for Patients With Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03460587
Enrollment
13
Registered
2018-03-09
Start date
2018-08-29
Completion date
2019-03-31
Last updated
2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICETelerehabilitation

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.

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥18 years at the time of randomization 2. 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 3. 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 4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the first visit 5. Informed consent signed by the subject 6. Behavioral contract signed by the subject

Exclusion criteria

1. A major, active, coexistent neurological or psychiatric disease, including alcoholism or dementia 2. A diagnosis (apart from the index stroke) that substantially affects paretic arm function 3. A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures 4. Severe depression, defined as Geriatric Depression Scale Score \>11 5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score \< 22; note that this

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Arm Motor Scale90 daysmeasure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment

Secondary

MeasureTime frameDescription
Fugl-Meyer Leg Motor Scale90 daysmeasure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment

Countries

United States

Participant flow

Participants by arm

ArmCount
Home-based Telerehabilitation
Home-based Telerehabilitation 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.
13
Total13

Baseline characteristics

CharacteristicHome-based Telerehabilitation
Age, Continuous61 years
Arm motor Fugl-Meyer score46 units on a scale
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Leg motor Fugl-Meyer score28 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
3 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
9 Participants
Region of Enrollment
United States
13 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
9 Participants
Time post-stroke129 days

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 13
other
Total, other adverse events
0 / 13
serious
Total, serious adverse events
0 / 13

Outcome results

Primary

Fugl-Meyer Arm Motor Scale

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

Time frame: 90 days

Population: All patients who signed informed consent.

ArmMeasureValue (MEDIAN)
Home-based TelerehabilitationFugl-Meyer Arm Motor Scale59 units on a scale
Secondary

Fugl-Meyer Leg Motor Scale

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

Time frame: 90 days

Population: All patients who signed informed consent

ArmMeasureValue (MEDIAN)
Home-based TelerehabilitationFugl-Meyer Leg Motor Scale28 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026