Stroke
Conditions
Keywords
telerehab, telerehabilitation, telehealth, brain plasticity
Brief summary
The purpose of this research study is to assess the feasibility of initiating telerehab in early stages after stroke during patient admission to an inpatient rehabilitation facility. Patients will complete 36 sessions of telerehab 6 days/week up to 8 weeks with a telehealth system provided in their hospital room and at their home. The system will include rehabilitation activities/exercises, education, and assessments to evaluate the patient experience and measure patient outcomes at the end of a 6-week course of telerehab.
Detailed description
Stroke is a major cause of disability. Loss of movement is a major part of this. Studies show that high doses of rehabilitation therapy can reduce disability, but many patients do not receive this, e.g., due to obstacles such as difficulty accessing care. The research team has previously found that telerehabilitation is an effective way to deliver care and improve outcomes. These prior studies were performed after hospital discharge, when patients were already back at home. The current study aims to extend this work by introducing telerehabilitation to the bedside of patients admitted to an inpatient rehabilitation facility. In this study, key areas of interest include issues related to, and the clinical effects of, telerehabilitation that is started during the rehab admission and is continued after discharge in the patient's home.
Interventions
DEVICETelerehabilitation
The telerehabilitation system will deliver rehabilitation treatment sessions via a secured 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 remote-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
Moss Rehabilitation Research Institute
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All enrollees will receive telerehabilitation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Stroke that has been radiologically verified 3. Arm motor FM score \<56 (out of 66) at initial visit 4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at initial visit 5. Informed consent and behavioral contract signed by the subject 6. Admitted to California Rehabilitation Institute or MossRehab for stroke rehabilitation
Exclusion criteria
1. A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia) 2. A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures 3. Severe depression, as defined as Geriatric Depression Scale Score \>10 at initial visit 4. Significant cognitive impairment, as defined as Montreal Cognitive Assessment score \<22 (lower score permitted if due to aphasia with approval from Dr. Cramer) 5. Deficits in communication that interfere with reasonable study participation 6. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye 7. Life expectancy \<6 months 8. Pregnant 9. 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 within 3 months of study enrollment 10. Unable to successfully perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy 11. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures 12. Expectation that subject will not have a single domicile address during the 6 weeks of therapy that has either Verizon wireless reception or a home WiFi network and that has space for the telerehab system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days) | 60 days | Measure of arm impairment. Scores range from 0-66, with higher numbers reflecting less arm impairment. We will be measuring change in scores from baseline to end of treatment (60 days). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telerehabilitation Patients will receive 36 treatment sessions over 6 weeks, consisting of 3 sessions/week that are supervised rehab therapy sessions (which begin with a 30-minute videoconference with the licensed OT or PT), alternating with 3 sessions/week of unsupervised rehab therapy sessions whereby the patient follows the instructions on the screen to engage in rehab therapy. Because patients sometimes miss a session, e.g., due to a conflict, we allow up to 8 weeks for patients to complete their 36 rehab therapy sessions.
Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured 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 remote-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. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Completed training but withdrew before follow-up testing due to change in medical status | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Telerehabilitation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 8 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 | 7 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 2 / 19 |
| serious Total, serious adverse events | 4 / 19 |
Outcome results
Primary
Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days)
Measure of arm impairment. Scores range from 0-66, with higher numbers reflecting less arm impairment. We will be measuring change in scores from baseline to end of treatment (60 days).
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telerehabilitation | Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days) | 18.07 units on a scale | Standard Deviation 10.85 |