Telerehabilitation for Stroke Survivors

Overseen By Fadi Musfee, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Aphasia, Dementia, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate the feasibility of a mobile telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke survivors with community health worker (CHW) at-home support and to estimate the functional health, mental health (depression), and caregiver burden outcomes of this new CHW-supported, at-home rehabilitation service delivery model and to identify salient barriers to and facilitators of adopting and delivering the new rehabilitation delivery model to further disseminate the model in real-world communities.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment CHW-supported telerehabilitation for stroke survivors?

Research shows that telerehabilitation can help improve upper limb function, balance, and independence in daily activities for stroke survivors. Studies have found it to be as effective as traditional in-person therapy, with added benefits like convenience and cost savings. ^{1 2 3 4 5}

Is telerehabilitation safe for stroke survivors?

The research on telerehabilitation for stroke survivors does not specifically mention safety concerns, suggesting it is generally considered safe. However, more detailed studies are needed to confirm its safety in routine care. ^{1 3 6 7 8}

How is CHW-supported telerehabilitation different from other stroke treatments?

CHW-supported telerehabilitation is unique because it allows stroke survivors to receive therapy remotely, using technology to deliver physical, occupational, and speech therapies at home. This approach can be more convenient and accessible than traditional in-person therapy sessions, especially for those with mobility challenges. ^{1 2 9 10 11}

Research Team

Fadi Musfee, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for stroke survivors in Brownsville, Texas who can stand (with help if needed), had their first stroke within the last 3 months, and were not severely disabled before the stroke. Participants must be uninsured, speak Spanish or English, able to do basic exercises safely, and follow instructions despite any aphasia.

Inclusion Criteria

Currently uninsured

Safe to perform basic strengthening rehabilitation exercises

I can stand up with or without help.

Exclusion Criteria

I have received outpatient rehab services before joining this study.

I do not have any conditions like aphasia or dementia that make it hard for me to follow instructions.

Insured patients as insured patients are referred for standard-of-care clinical rehabilitation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive CHW-supported telerehabilitation for post-acute stroke care

6 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• CHW-supported telerehabilitation

Trial Overview The study tests a new at-home telerehabilitation service with community health worker support against usual care. It aims to see how well it works for improving physical and mental health of stroke survivors in Rio Grande Valley and understand barriers and facilitators for its use.

Participant Groups

Group I: CHW-supported telerehabilitation Experimental Treatment 1 Intervention

Group II: Usual care Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

The pilot study involving seven adults with chronic stroke demonstrated that a home-based telerehabilitation program significantly improved upper limb performance over 6 weeks of training, with participants training 5 days a week for 60 minutes each session.

In addition to physical improvements, there were indications of potential cognitive benefits, suggesting that telerehabilitation may enhance overall recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based telerehabilitation shows improved upper limb function in adults with chronic stroke: a pilot study. Langan, J., Delave, K., Phillips, L., et al.[2021]

In a study involving ten chronic post-stroke subjects, the telerehabilitation system Muvity showed potential benefits, with four out of six participants improving their ability to perform daily activities and five reporting less pain compared to conventional therapy.

While the results were promising, indicating that Muvity could be a motivating and effective complement to traditional rehabilitation, the differences were not statistically significant, highlighting the need for further research with a larger sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study to assess the effectiveness of Muvity: A telerehabilitation system for chronic post-stroke subjects. Garcia, A., Mayans, B., Margelí, C., et al.[2022]

Telerehabilitation has a small but statistically significant effect on improving balance and functional mobility in stroke survivors, based on a systematic review of 14 studies involving 594 patients.

Despite these positive findings, the overall quality of evidence is low, indicating a need for more rigorous research to confirm the effectiveness of telerehabilitation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Telerehabilitation on Balance and Functional Mobility in Patients with Stroke: A Systematic Review and Meta-Analysis. Alayat, MS., Almatrafi, NA., Almutairi, AA., et al.[2023]

Telerehabilitation programs after stroke showed equivalent or improved functional outcomes compared to traditional face-to-face therapy, particularly in motor function and mobility assessments, based on a systematic review of 13 studies and a meta-analysis of 10 trials.

Patient adherence to telerehabilitation was high, ranging from 75% to 100%, indicating that patients are willing to engage with these programs, although satisfaction levels varied and highlight the need for better standardization in therapy protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation service impact on physical function and adherence compared to face-to-face rehabilitation in patients with stroke: A systematic review and meta-analysis. Sharififar, S., Ghasemi, H., Geis, C., et al.[2023]

Telerehabilitation (TR) applications show promise, with 71% of the 61 reviewed studies reporting successful outcomes, particularly in cardiac and neurological rehabilitation.

However, only 51% of the applications demonstrated clinically significant results, and further high-quality research is needed to establish TR as a standard practice in routine rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of benefit from telerehabilitation in routine care: a systematic review. Hailey, D., Roine, R., Ohinmaa, A., et al.[2022]

A study involving 4 stroke survivors using the Tele-REINVENT system for 6 weeks revealed that factors like biofeedback, customization, gamification, and predictability significantly influenced the acceptability of this telerehabilitation tool.

Participants preferred features that provided them with agency and control, suggesting that enhancing user experience can improve the effectiveness and acceptance of at-home EMG biofeedback interventions for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Telerehabilitation Biofeedback System Among Stroke Survivors: A Qualitative Analysis. Donnelly, MR., Phanord, CS., Marin-Pardo, O., et al.[2023]

Tele-rehabilitation for stroke survivors shows promise in improving recovery from motor deficits, cognitive dysfunction, and post-stroke depression, based on a systematic review of 22 studies.

While most studies indicated positive effects of tele-rehabilitation, only 8 out of 22 showed significant differences favoring tele-rehabilitation over standard care, suggesting that while effective, results may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Rehabilitation after Stroke: An Updated Systematic Review of the Literature. Sarfo, FS., Ulasavets, U., Opare-Sem, OK., et al.[2023]

A study involving 49 subacute stroke survivors indicated that telerehabilitation using a guided app for core stability exercises may improve balance and gait compared to usual care, although the differences were not statistically significant.

The findings suggest that home-based telerehabilitation could be a feasible option for enhancing recovery in post-stroke patients, but further research is needed to confirm these effects and improve adherence to the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation for balance rehabilitation in the subacute stage of stroke: A pilot controlled trial. Salgueiro, C., Urrútia, G., Cabanas-Valdés, R.[2022]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Home-based telerehabilitation shows improved upper limb function in adults with chronic stroke: a pilot study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A feasibility study to assess the effectiveness of Muvity: A telerehabilitation system for chronic post-stroke subjects. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of Telerehabilitation on Balance and Functional Mobility in Patients with Stroke: A Systematic Review and Meta-Analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness, usability, and cost-benefit of a virtual reality-based telerehabilitation program for balance recovery after stroke: a randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Tele-rehabilitation on independence in activities of daily living after stroke: A Matched Case-Control Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Telerehabilitation service impact on physical function and adherence compared to face-to-face rehabilitation in patients with stroke: A systematic review and meta-analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Evidence of benefit from telerehabilitation in routine care: a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Acceptability of a Telerehabilitation Biofeedback System Among Stroke Survivors: A Qualitative Analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Tele-Rehabilitation after Stroke: An Updated Systematic Review of the Literature. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility of integrative games and novel therapeutic game controller for telerehabilitation of individuals chronic post-stroke living in the community. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Telerehabilitation for balance rehabilitation in the subacute stage of stroke: A pilot controlled trial. [2022]