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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist stroke survivors and their family caregivers with home recovery. The aim is to determine if a web-based program, called CARE-CITE, can engage family members in the rehabilitation process without overwhelming them. It involves two main groups: one for caregivers and one for stroke survivors, each receiving either virtual therapy or traditional written materials. This trial may be suitable if a stroke occurred in the past 3 months to 2 years and assistance with daily activities is needed, with a caregiver living in the same home. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance home-based stroke recovery.

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 prior data suggests that this telerehabilitation program is safe for stroke survivors and care partners?

Research has shown that telerehabilitation programs like CARE-CITE are generally safe and well-received by participants. Studies have found that these programs often achieve similar or even better results compared to traditional therapy, indicating they don't pose significant safety concerns.

The CARE-CITE program specifically involves family members in the rehabilitation process. It has shown promising results in improving both the mental health of family members and the physical abilities of stroke survivors. Past studies with similar programs have reported no major negative events.

While detailed data on the safety of CARE-CITE itself is lacking, its nature as a web-based education program suggests a low risk of harmful effects. These programs usually focus on teaching and guidance rather than direct physical treatment, reducing the chance of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telerehabilitation Program for Stroke because it takes stroke recovery into the digital age with its virtual Collaborative Integrated Therapy (CARE-CITE). Unlike standard treatments that often rely on in-person therapy sessions or traditional educational materials, CARE-CITE offers a convenient, remote program that supports both stroke survivors and their care partners through an interactive, family-centered approach. This method not only provides flexibility, reducing the need for travel to therapy sessions, but also emphasizes the role of family in recovery, potentially enhancing the overall rehabilitation process. By leveraging technology, this program aims to make stroke rehabilitation more accessible and engaging, which could lead to better outcomes for patients and their families.

What evidence suggests that the CARE-CITE program is effective for stroke rehabilitation?

This trial will evaluate the effectiveness of the CARE-CITE telerehabilitation program for stroke recovery. Studies have shown that telerehabilitation programs like CARE-CITE can be as effective, or even more so, than traditional in-person therapy for improving movement skills. Research indicates that learning about stroke prevention through telerehabilitation increases knowledge by 39%. This type of program also enhances overall recovery outcomes. One study found that telerehabilitation significantly benefited family caregivers, making it a promising option for involving care partners. These findings support the effectiveness of CARE-CITE in aiding stroke survivors and their families. Participants in this trial will be divided into groups receiving either the CARE-CITE program or traditional educational materials. ^{2 3 4 6 7}

Who Is on the Research Team?

Sarah Blanton, PT, DPT

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06655402

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5734923/

A Home-Based Telerehabilitation Program for Patients with ... Daily stroke education via the telerehabilitation system was associated with a 39% increase in stroke prevention knowledge (p=0.0007). Depression scores ...

3. withpower.com withpower.com/trial/telerehabilitation-program-for-stroke-74036

Telerehabilitation Program for Stroke (CARE-CITE Trial) Telerehabilitation programs after stroke showed equivalent or improved functional outcomes compared to traditional face-to-face therapy, particularly in motor ...

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. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/3450312

Telerehabilitation for Family Caregivers of Stroke Survivors ... The subgroup analysis demonstrated that multi-form telerehabilitation (SMD = 1.86, 95% CI = 1.32∼2.40, P < 0.001) was significantly effective in ...

6. reporter.nih.gov reporter.nih.gov/project-details/11140477

Project Details The specific aims are to determine the effects of CARE-CITE on stroke survivor upper extremity functional capacity (Aim 1), upper extremity daily activity ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05257928

Carepartner Collaborative Integrated Therapy Gait (CARE ... Promising preliminary data showed improvement in CP psychosocial outcomes and SS upper extremity function. The potential impact of CARE-CITE on SS mobility and ...