Telerehabilitation for Stroke

(TR-2 Trial)

Recruiting at 9 trial locations

Overseen By Steven Cramer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Botulinum toxin

Disqualifiers: Neurological, Psychiatric, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 40

Duration: 6 weeks

202 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding telerehabilitation (home-based therapy guided by a therapist) to usual care can improve arm function and reduce overall disability after a stroke. Participants will either receive telerehabilitation alongside their regular care or continue with their regular care, with the option to try telerehabilitation after the study. The trial focuses on individuals who experienced a stroke 90-150 days ago and have resulting arm weakness. As an unphased trial, it offers a unique opportunity to explore innovative rehabilitation methods that could enhance recovery and improve quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that telerehabilitation is safe for stroke patients?

A previous study found telerehabilitation (rehab done remotely) to be quite safe. Out of 65,352 sessions, only 201 adverse events occurred, approximately 3.1 events per 1,000 sessions. These events mainly involved physical issues, such as falls. Another study demonstrated that telerehabilitation is safe and effective for stroke recovery, aiding movement, communication, and mood. Research suggests that intensive telerehabilitation at home is both safe and feasible, even shortly after a stroke. This allows people to receive necessary therapy without leaving their homes, proving as effective as attending a rehab center. Overall, the strong safety record of telerehabilitation makes it a promising option for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telerehabilitation for stroke recovery because it offers a new way to deliver therapy remotely, making it more accessible for patients who face challenges attending in-person sessions. Unlike traditional rehabilitation, which requires frequent visits to a clinic, telerehabilitation allows patients to engage in therapy from home, integrating 70 minutes of targeted arm exercises into their daily routine. This approach not only provides flexibility but also ensures that patients receive a mix of supervised and independent sessions, potentially enhancing motivation and adherence to therapy.

What evidence suggests that telerehabilitation is effective for improving arm function after stroke?

Research has shown that telerehabilitation, which participants in this trial may receive, helps stroke survivors improve arm movement. Studies have found it works as effectively as traditional therapy sessions in a clinic for enhancing motor skills. Telerehabilitation enables therapists to assist patients remotely, making it easier for those living far from therapy centers to access care. Previous reviews suggest that telerehabilitation not only aids physical recovery but also enhances overall quality of life. For patients recovering from a stroke, telerehabilitation can play a crucial role in their recovery journey. ^{6 7 8 9 10}

Who Is on the Research Team?

Steven Cramer, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for individuals who had a stroke 90-150 days ago, resulting in arm weakness. They must be able to follow simple commands and perform basic rehabilitation exercises. Participants need an Action Research Arm Test score of 18-44 and should move at least one block using the affected arm in a Box & Block Test within 60 seconds.

Inclusion Criteria

My arm's movement is limited due to a stroke.

I can do all 3 rehab exercises as shown at my first visit.

My stroke was confirmed by imaging 90 to 150 days ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telerehabilitation targeting arm function, consisting of 70 minutes/day of activities, 6 days a week for 6 weeks

6 weeks

36 sessions (half supervised, half independent)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of arm function and a single MRI scan

2 months

4 visits (in-person)

Open-label extension (optional)

Participants in the usual care group are offered telerehabilitation after the study is completed

What Are the Treatments Tested in This Trial?

Interventions

• Telerehabilitation

Trial Overview The study is testing if telerehabilitation (TR) targeting arm movement plus usual care improves arm function after stroke better than usual care alone. TR involves daily activities for the arms, done at home for six weeks, with sessions lasting about 70 minutes each day.

How Is the Trial Designed?

Group I: Telerehabilitation + Usual Care Experimental Treatment 1 Intervention

Patients will receive 36 telerehabilitation sessions targeting arm motor function in addition to their usual care. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently.

Group II: Usual Care Active Control 1 Intervention

Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team. All participants in this group will be offered TR at the end of the study.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Moss Rehabilitation Research Institute

Collaborator

Trials

12

Recruited

10,100+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10744683/

Telerehabilitation for Stroke: A Personalized Multi-Domain ... TR allows therapists to assess, treat, and monitor patients from a distance, eliminating geographical barriers and improving accessibility to ...

2. jmir.org jmir.org/2018/10/e10867/

Telerehabilitation for Stroke Survivors: Systematic Review ... Telerehabilitation can be a suitable alternative to usual rehabilitation care in poststroke patients, especially in remote or underserved areas.

3. tandfonline.com tandfonline.com/doi/full/10.1080/10833196.2024.2400425

Effectiveness of telerehabilitation on quality of life in stroke ... Overall, the current review provides positive results that suggests telerehabilitation is effective, adding to the findings of previous systematic reviews ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586825002176

A randomized controlled Trial of telerehabilitation ... The findings of this study support telerehabilitation interventions as an effective rehabilitation method, significantly improving the rehabilitation outcomes ...

5. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2736341

Efficacy of Home-Based Telerehabilitation vs In-Clinic ... Telerehabilitation showed comparable efficacy to traditional in-clinic rehabilitation for improving motor status (Fugl-Meyer arm motor scale) and for improving ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12266302/

The Safety of Telerehabilitation: Systematic Review - PMC A total of 201 adverse events were recorded during 65,352 sessions (0.31% or 3.1 per 1000 sessions). These events were predominantly physical (eg, falls and ...

7. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.121.033289

Telerehabilitation: Has Its Time Come? | Stroke Telerehabilitation can deliver stroke rehabilitation services to manage functional recovery, motor recovery, communication, depression, and stroke risk factors ...

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1234003/full

ICTs & Interventions in Telerehabilitation for Stroke Recovery Their results suggest the TR system is safe, feasible and able to provide intensive therapy at home for lower limb trainings. Lin et al. (46) ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36876946/

Telerehabilitation Initiated Early in Post-Stroke Recovery Conclusions: These results support feasibility, safety, and potential efficacy of providing intense TR therapy early after stroke. Clinical ...

10. obrienphysicaltherapy.net obrienphysicaltherapy.net/blog/post-stroke-rehabilitation-outcomes-statistics-on-physical-therapy-effectiveness

Post-Stroke Rehabilitation Outcomes: Statistics on Physical ... Research shows that home-based telerehabilitation can be as effective as outpatient hospital therapy for stroke patients. In clinical trials, ...