Telerehabilitation Program for Stroke

(CARE-CITE Trial)

Overseen By Sarah R Blanton, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Significant cognitive deficits

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

Compensation: Varies

Number of Visits: 4

220 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment CARE-CITE in the Telerehabilitation Program for Stroke?

Research shows that telerehabilitation, which uses technology to provide therapy remotely, can help improve balance and mobility in stroke survivors. Virtual reality-based telerehabilitation has been found effective for balance recovery, suggesting that similar approaches like CARE-CITE could also be beneficial. ^{1 2 3 4 5}

Is telerehabilitation safe for stroke patients?

The available research on telerehabilitation for stroke patients does not report any significant safety concerns, suggesting it is generally safe for use in humans. ^{4 6 7 8 9}

How is the CARE-CITE treatment for stroke different from other treatments?

CARE-CITE is unique because it uses telerehabilitation, which means patients receive rehabilitation services through technology, allowing them to do exercises and receive support from home. This approach is different from traditional in-person therapy and can be more convenient and accessible for stroke patients. ^{5 6 9 10 11}

What is the purpose of this trial?

Stroke is a leading cause of long-term disability. Research has placed little emphasis on integrating care partners (CP) (family members) into the rehabilitation process without increasing negative care partner outcomes. The research team has developed and implemented a novel, web-based care partner-focused intervention (CARE-CITE) designed to foster problem-solving and skill building while facilitating care partner engagement during stroke survivor (SS) upper extremity practice of daily activities in the home setting. By providing a family-focused approach to rehabilitation interventions, this project will help develop more effective treatments that improve CP and outcomes after stroke.

Research Team

Sarah Blanton, PT, DPT

Principal Investigator

Emory University

Eligibility Criteria

This trial is for stroke survivors and their family members who help with daily care. Participants must be adults, have internet access, and a family member willing to join the study. People can't participate if they have conditions that would interfere with using the web-based program or are already receiving similar rehabilitation services.

Exclusion Criteria

Both CarePartners and Stroke Survivors must not have significant cognitive deficits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 virtual visit

Intervention

Participants receive the CARE-CITE program or attention control materials for 4 weeks

4 weeks

2 virtual home visits, 2 phone check-ins

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

1 booster call, 1 booster virtual home visit

Treatment Details

Interventions

• CARE-CITE

Trial Overview The study tests CARE-CITE, a web-based program helping caregivers assist in rehabilitating stroke survivors' arm use at home. It's compared to an attention control group not using CARE-CITE but monitored for activity levels using Actigraph GT3X+ devices.

Participant Groups

Group I: CARE-CITE- Stroke Survivors (Intervention Group) Experimental Treatment 2 Interventions

This study arm consists of stroke survivors (SS) of carepartners receiving the virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program.

Group II: CARE-CITE- CarePartners (Intervention Group) Experimental Treatment 1 Intervention

The CP will receive virtual Collaborative Integrated Therapy (CARE-CITE), a post-stroke family education program.

Group III: Attention Control Group-CarePartners Active Control 1 Intervention

CP in this group will receive traditional written family educational materials to review during the 4-week intervention period.

Group IV: Attention Control Group-Stroke Survivors Active Control 2 Interventions

This study arm consists of stroke survivors (SS) of carepartners receiving the traditional written family educational materials to review during the 4-week intervention period.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

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 effectively delivers a wide range of rehabilitation services through technology, allowing for assessment, monitoring, and intervention across various settings such as homes, clinics, and schools.

This document serves as a guideline for practitioners to ensure that telerehabilitation services are safe, effective, and tailored to client needs, promoting the development of discipline-specific standards in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A blueprint for telerehabilitation guidelines. Brennan, D., Tindall, L., Theodoros, D., et al.[2022]

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]

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]

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]

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]

References

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

Effectiveness of telerehabilitation in the management of adults with stroke: A systematic review. [2020]

2. 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]

3. 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]

4. 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]

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

A blueprint for telerehabilitation guidelines. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Can post stroke walking improve via telerehabilitation? A systematic review in adults with stroke. [2023]

7. 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]

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

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

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

Investigating the Telerehabilitation with Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL) Program: A Feasibility Study. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

11. Sweden pubmed.ncbi.nlm.nih.gov

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