Telehealth Therapy for Stroke

Overseen By Emily Kringle, PhD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Neurodegenerative disorders, Cancer, Major depression, others

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

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

92 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial to test whether a remotely delivered behavioral activation-based intervention called "teleABLE" works better than a health education intervention for (1) reducing sitting time and (2) improving health-related quality among adults who were diagnosed with stroke within the past 12 months. Participants in this study will: * Complete questionnaires at Weeks 1, 8, and 24 * Wear an activPAL monitor at Weeks 1, 8, and 24 * Participate in the teleABLE intervention (12 sessions) or the health education intervention (6 sessions) * Complete an interview at Week 24

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment teleABLE for stroke?

Research shows that telerehabilitation, which includes remote therapy and feedback, can improve access to therapy for stroke survivors and enhance their recovery. Additionally, virtual reality and gaming-based interventions have been found effective in improving upper limb function after a stroke, suggesting that similar telehealth approaches like teleABLE could be beneficial. ^{1 2 3 4 5}

Is telehealth therapy for stroke generally safe for humans?

The available research does not provide specific safety data for telehealth therapy for stroke, but it discusses its use in managing stroke care and improving access to therapy. No significant safety concerns are mentioned in the context of telehealth interventions for stroke patients. ^{2 6 7 8 9}

How is the teleABLE treatment for stroke different from other treatments?

The teleABLE treatment is unique because it uses telehealth to deliver therapy, focusing on activating behavior for lasting engagement, which may improve access and adherence to rehabilitation for stroke survivors. This approach is different from traditional in-person therapy by providing remote, continuous support and potentially enhancing patient engagement and self-management. ^{1 2 10 11 12}

Research Team

Emily Kringle, PhD, OTR/L

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for adults who had a stroke within the last year. They should be able to complete questionnaires, wear an activity monitor, and attend telehealth sessions. Specific details on what conditions exclude someone from participating are not provided.

Inclusion Criteria

≥6 hours of sedentary behavior on a typical weekday (Sedentary Behavior Questionnaire)

Able to access an electronic device (smartphone, tablet, or computer) that is compatible with a videoconferencing application

I was diagnosed with a stroke less than a year ago.

Exclusion Criteria

I am currently receiving chemotherapy or radiation for another cancer.

Diagnosis of a terminal illness and/or currently receiving hospice care

History of skin sensitivity that precludes the use of medical tape necessary for adherence to activity monitor measure

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the teleABLE intervention (12 sessions) or the health education intervention (6 sessions) over 6 weeks

6 weeks

12 sessions (teleABLE) or 6 sessions (Health Education), all remote

Follow-up

Participants complete questionnaires and wear an activPAL monitor at Weeks 1, 8, and 24, and complete an interview at Week 24

24 weeks

3 visits (remote)

Treatment Details

Interventions

• teleABLE

Trial Overview The study compares 'teleABLE', a behavioral activation intervention delivered remotely aimed at reducing sitting time and improving quality of life post-stroke, with a standard health education program.

Participant Groups

Group I: teleABLE Experimental Treatment 1 Intervention

Participants meet with a study therapist 2x/week for 6 weeks (12 sessions) to complete behavioral activation focused on adding personally meaningful non-sedentary activities during times when they typically spend sitting. All sessions are delivered remotely using Zoom videoconferencing.

Group II: Health Education Active Control 1 Intervention

Participants meet with a study therapist 1x/week for 6 weeks (6 sessions) to review fact sheets focused on healthy lifestyles after stroke. All sessions are delivered remotely using Zoom videoconferencing.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

A new pilot program is being implemented in acute stroke units to enhance recovery by introducing a video-gaming intervention called restorative neuroanimation, which aims to provide additional high-intensity behavioral treatment during the early recovery period.

This intervention is designed to complement traditional rehabilitation methods and take advantage of a critical period of brain plasticity, potentially improving outcomes for stroke patients beyond what is achieved through spontaneous recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bringing High-Dose Neurorestorative Behavioral Training Into the Acute Stroke Unit. Bahouth, MN., Zink, EK., Ahmad, O., et al.[2023]

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]

Virtual reality (VR) and gaming interventions led to an average improvement of 28.5% in upper extremity function for stroke patients, showing significant effectiveness compared to conventional rehabilitation methods.

Incorporating a gaming component into VR training resulted in a 10.8% greater improvement in rehabilitation outcomes, highlighting the importance of engaging treatment strategies in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. Karamians, R., Proffitt, R., Kline, D., et al.[2020]

The ongoing Phase II trial is evaluating a multifaceted telerehabilitation (TR) intervention for stroke patients, aiming to improve physical function and patient satisfaction through home-based assessments and tailored exercises over a 3-month period with 50 participants.

The TR intervention may enhance recovery by providing continuous support and rehabilitation in the home environment, which could be especially beneficial for patients in remote areas, potentially reducing the need for prolonged hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: home-based telehealth stroke care: a randomized trial for veterans. Chumbler, NR., Rose, DK., Griffiths, P., et al.[2022]

Stroke is a leading cause of death and disability, yet many patients do not receive the effective treatment of intravenous tissue plasminogen activator due to barriers like lack of access to specialists, especially in rural areas.

Telemedicine, specifically telestroke systems, has emerged as a promising solution to improve access to acute stroke care, showing safety and efficacy in observational studies, and could expand to enhance overall stroke management beyond just the initial treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on telemedicine to improve stroke treatment. Stewart, SF., Switzer, JA.[2017]

Telehealth has rapidly expanded in chronic care management, particularly for stroke survivors, but evidence on its effectiveness in reducing disparities in chronic stroke care is still limited.

Ongoing large randomized trials are exploring telehealth and telemonitoring for blood pressure management in diverse populations, highlighting both the potential benefits and barriers of telehealth in improving stroke outcomes related to social determinants of health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Trials to Address Health Equity in Stroke Survivors. Sharrief, AZ., Guzik, AK., Jones, E., et al.[2023]

Remote interventions, such as telemedicine and mobile health (mHealth) technologies, significantly improve medication adherence in stroke patients, with a standardized mean difference of 0.49 based on a meta-analysis of 10 studies involving various patients.

These interventions not only enhance adherence but also lead to significant improvements in clinical outcomes, including lower blood pressure and cholesterol levels, indicating their potential effectiveness as part of stroke rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Remote Interventions to Improve Medication Adherence in Patients after Stroke: A Systematic Literature Review and Meta-Analysis. Choi, YYC., Fineberg, M., Kassavou, A.[2023]

In a study of hypertensive stroke patients, telestroke technology allowed for thrombolysis therapy to be administered to 89% of patients, compared to only 62% in the non-telestroke group, indicating its effectiveness in improving treatment access.

The only significant factor associated with receiving thrombolysis in the telestroke group was direct admission to the telestroke network, suggesting that this technology may reduce the impact of traditional clinical risk factors that often exclude patients from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of thrombolysis in the telestroke and non telestroke settings for hypertensive acute ischemic stroke patients. Brecthel, L., Gainey, J., Penwell, A., et al.[2023]

In a study of 3202 acute ischemic stroke patients, including 312 diabetic patients, telestroke technology was found to significantly increase the likelihood of including diabetic patients for thrombolysis therapy compared to non-telestroke settings.

In the non-telestroke group, factors such as older age, higher blood glucose levels, and renal insufficiency were associated with exclusion from thrombolysis, suggesting that addressing these clinical risk factors could enhance treatment opportunities for diabetic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The telestroke and thrombolysis therapy in diabetic stroke patients. Nathaniel, TI., Ubah, C., Wormack, L., et al.[2022]

The tele-rehabilitation approach, tele-CO-OP, was found to be feasible and acceptable for participants with chronic stroke, showing high satisfaction and engagement with the training.

Participants who received tele-CO-OP experienced significant improvements in social participation and mood, with large effect sizes indicating beneficial transfer of learning effects compared to those on the waitlist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategy-training post-stroke via tele-rehabilitation: a pilot randomized controlled trial. Dawson, DR., Anderson, ND., Binns, M., et al.[2022]

A preliminary study on the TheraDrive rehabilitation system indicates that a fun and engaging therapy protocol may lead to better outcomes in reducing motor impairment and improving daily living functions compared to a less engaging approach.

The engaging therapy protocol not only showed small advantages in rehabilitation effectiveness but also helped maintain participant interest and motivation during therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the TheraDrive system for robot/computer assisted motivating rehabilitation after stroke. Ruparel, R., Johnson, MJ., Strachota, E., et al.[2020]

The Augmented Community Telerehabilitation Intervention (ACTIV) did not show a significant improvement in physical function for all participants compared to usual care, with a P-value of 0.07 in the postintervention analysis of 95 stroke patients.

However, a per-protocol analysis indicated that participants who engaged with more than 50% of the ACTIV program experienced significant improvements in physical function (P = 0.04), suggesting that higher engagement may lead to better outcomes shortly after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation After Stroke Using Readily Available Technology: A Randomized Controlled Trial. Saywell, NL., Vandal, AC., Mudge, S., et al.[2021]

References

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

Bringing High-Dose Neurorestorative Behavioral Training Into the Acute Stroke Unit. [2023]

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

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

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

Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Study protocol: home-based telehealth stroke care: a randomized trial for veterans. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Perspectives on telemedicine to improve stroke treatment. [2017]

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

Telehealth Trials to Address Health Equity in Stroke Survivors. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Remote Interventions to Improve Medication Adherence in Patients after Stroke: A Systematic Literature Review and Meta-Analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Predictors of thrombolysis in the telestroke and non telestroke settings for hypertensive acute ischemic stroke patients. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The telestroke and thrombolysis therapy in diabetic stroke patients. [2022]

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

Strategy-training post-stroke via tele-rehabilitation: a pilot randomized controlled trial. [2022]

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

Evaluation of the TheraDrive system for robot/computer assisted motivating rehabilitation after stroke. [2020]

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

Telerehabilitation After Stroke Using Readily Available Technology: A Randomized Controlled Trial. [2021]