StrokeNCT04657770
Telerehabilitation Early After Stroke
A study testing Telerehabilitation in people with Stroke, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Telerehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 May 2021to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Stroke that has been radiologically verified
- Arm motor FM score <56 (out of 66) at initial visit
- Box \& Block Test score with affected arm is at least 3 blocks in 60 seconds at initial visit
- Informed consent and behavioral contract signed by the subject
- Admitted to California Rehabilitation Institute or MossRehab for stroke rehabilitation
Who cannot join
- A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)
- A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
- Severe depression, as defined as Geriatric Depression Scale Score >10 at initial visit
- Significant cognitive impairment, as defined as Montreal Cognitive Assessment score <22 (lower score permitted if due to aphasia with approval from Dr. Cramer)
- 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
Show all 12Show fewer
- Life expectancy <6 months
- Pregnant
- 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
- Unable to successfully perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
- 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 6 weeks of therapy that has either Verizon wireless reception or a home WiFi network and that has space for the telerehab system
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027
California Rehabilitation Institute
Los Angeles, California, 90067
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Telerehabilitation
- Keywords
- telerehab, telerehabilitation, telehealth, brain plasticity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | 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. Receives: Device: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start13 May 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Model description
- All enrollees will receive telerehabilitation.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Moss Rehabilitation Research Institute
- Responsible party
- Principal investigator, Steven C. Cramer, MD, FAAN, FAHA, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657770
- Sponsor's protocol ID
- 20-000994
- Status last verified
- Apr 2023
- First submitted
- 1 Dec 2020
- Last updated
- 19 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A deidentified dataset will be shared with appropriate personnel after the main study manuscript is published.
Publications
Edwards D, Kumar S, Brinkman L, Ferreira IC, Esquenazi A, Nguyen T, Su M, Stein S, May J, Hendrix A, Finley C, Howard E, Cramer SC. Telerehabilitation Initiated Early in Post-Stroke Recovery: A Feasibility Study. Neurorehabil Neural Repair. 2023 Feb-Mar;37(2-3):131-141. doi: 10.1177/15459683231159660. Epub 2023 Mar 6.
PubMed 36876946
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Early After Stroke
- ClinicalTrials.gov ID
- NCT04657770
- Acronym / sponsor ID
- 20-000994
- Conditions
- Stroke
- Keywords
- telerehab, telerehabilitation, telehealth, brain plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Moss Rehabilitation Research Institute
- Study start
- 13 May 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Posted 12 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrollees will receive telerehabilitation.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Device: TelerehabilitationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Stroke that has been radiologically verified
- Arm motor FM score <56 (out of 66) at initial visit
- Box \& Block Test score with affected arm is at least 3 blocks in 60 seconds at initial visit
- Informed consent and behavioral contract signed by the subject
Key exclusion criteria (12 listed)
- A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)
- A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
- Severe depression, as defined as Geriatric Depression Scale Score >10 at initial visit
- Significant cognitive impairment, as defined as Montreal Cognitive Assessment score <22 (lower score permitted if due to aphasia with approval from Dr. Cramer)
- Deficits in communication that interfere with reasonable study participation
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 |
|---|---|---|
| TelerehabilitationThe 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. | Device | Telerehabilitation |
Primary outcome
Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days)
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36876946Edwards D, Kumar S, Brinkman L, Ferreira IC, Esquenazi A, Nguyen T, Su M, Stein S, May J, Hendrix A, Finley C, Howard E, Cramer SC. Telerehabilitation Initiated Early in Post-Stroke Recovery: A Feasibility Study. Neurorehabil Neural Repair. 2023 Feb-Mar;37(2-3):131-141. doi: 10.1177/15459683231159660. Epub 2023 Mar 6.
- Individual participant dataSharing planned: Yes. A deidentified dataset will be shared with appropriate personnel after the main study manuscript is published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Stroke, run by University of California, Los Angeles at 2 sites 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 6 inclusion and 12 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days) (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04657770, which also lists 1 linked publication.
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 19 Apr 2023; AzTrials last refreshed its copy on 31 Oct 2026.