Home Telerehabilitation for Vascular Dementia

Overseen By Rachel Markley, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Severe psychiatric illnesses, Bilateral paresis, Severe uncontrolled medical problems, others

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

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if home telerehabilitation, a therapy conducted remotely using technology, can assist people who have had a stroke and are experiencing vascular dementia, a type of memory loss related to blood flow issues in the brain. The focus is on simplifying rehabilitation exercises at home and reducing caregiver stress. Participants will use an app to perform exercises at home, following an occupational therapist's plan. The trial seeks individuals who had a stroke at least six months ago and still retain some movement in their affected arm. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance rehabilitation options for stroke survivors.

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 trial coordinators or your doctor.

What prior data suggests that this home telerehabilitation therapy is safe for chronic stroke patients with and without vascular dementia?

Research shows that home telerehabilitation programs are safe for older adults with memory problems. Studies of these programs report no harmful effects. This treatment uses technology to guide exercises at home, and results indicate it can be as effective as traditional care. Evidence suggests that people with dementia tolerate this approach well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tele rehabilitation therapy for vascular dementia because it offers a unique approach compared to traditional therapies like in-person physical therapy or medication. This treatment is delivered via a user-friendly app, allowing patients to perform prescribed exercises at home with guidance, making it more accessible and convenient for both patients and caregivers. Furthermore, it provides detailed tracking of motor tasks and performance, enabling personalized adjustments to therapy. This innovative delivery method could enhance patient engagement and adherence, potentially leading to improved outcomes in managing vascular dementia symptoms.

What evidence suggests that home telerehabilitation therapy is effective for vascular dementia?

Research shows that rehabilitation exercises at home via video calls can aid people with memory and thinking problems, such as those in vascular dementia. In this trial, participants will engage in Home Tele Rehabilitation Therapy, which includes hand and arm exercises prescribed by occupational therapists. Studies have found that this method can improve conditions in dementia care. Notably, older adults who participated experienced no negative effects, which is encouraging. While more information is still being gathered, early results suggest this approach might help people manage daily tasks better and reduce caregiver stress. Overall, this therapy is considered safe and promising for those with vascular dementia. ^{2 5 6 7 8}

Who Is on the Research Team?

Timea Hodics, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a stroke at least 6 months ago and have some movement in their affected arm. They must be able to follow simple commands, use the therapy system with little help, and have someone to assist them. It's not for those in other similar studies, non-English speakers without a translator, pregnant women, prisoners, or people with severe mental health issues or medical conditions.

Inclusion Criteria

Expressed willingness to comply with all study procedures and attend all study-related visits for both the patient and at least one caregiver

Ability to operate the therapy system with minimal assistance, including sufficient corrected vision to perceive objects from a distance of 5 feet

Modified Ashworth Scale Score 3 or less in the involved upper extremity

Exclusion Criteria

Concurrent participation in other experimental upper extremity rehabilitation trials that would interfere with results

Non-English-speaking individuals will only be eligible if they can provide the appropriate translator for all the sessions of the study as no funding is available to pay for such services. However, we plan to include them once funding has been secured in the subsequent larger trial

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Evaluation

Initial evaluation includes questionnaires, impairment and functional scales, and collection of demographic and medical history

1 week

1 visit (in-person)

Usual Care

Participants perform conventional home rehabilitation for 4 weeks

4 weeks

Telerehabilitation Treatment

Participants undergo telerehabilitation therapy with occupational therapist prescribed exercises for 4 weeks

4 weeks

Remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home Tele Rehabilitation Therapy

Trial Overview The study tests if home telerehabilitation therapy can be done easily and helps reduce the stress on caregivers of chronic stroke patients with or without vascular dementia. Participants will use a special system from home to perform rehabilitation exercises.

How Is the Trial Designed?

Group I: Tele Rehabilitation Experimental Treatment 1 Intervention

Telerehabilitation therapy Occupational therapist prescribed hand/arm exercises will continue for 90 minutes per day with adequate rest periods for 4 weeks, followed by telerehabilitation with the application for 4 weeks, when subjects will perform the tasks at home with the guidance of the treatment app. Detailed records of each subject's motor tasks, number of repetition and level of performance will be kept. Treatment will be performed Monday-Friday for approximately 4 weeks. Treatment times can be broken up into multiple treatment periods to accommodate patient and caregiver preferences.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Published Research Related to This Trial

A study involving 19 post-stroke patients demonstrated that telerehabilitation (TR) using a Virtual Reality Rehabilitation System significantly improved motor recovery, as measured by the Barthel Index, Fugl-Meyer motor score, and Motricity Index after 12 weeks of treatment.

This research highlights the feasibility and effectiveness of TR in a low-income region of Italy, where access to traditional rehabilitation services is limited, suggesting that TR can be a valuable alternative for patients in similar situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Telerehabilitation in Calabria: A Health Technology Assessment. Contrada, M., Arcuri, F., Tonin, P., et al.[2022]

Telerehabilitation using videoconferencing significantly helped families caring for individuals with prolonged reduced consciousness, as more patients in this group remained at home and returned for rehabilitation compared to a control group.

Families using videophone support reported that their needs were better met, indicating that this approach can enhance caregiver support and potentially improve the overall care experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation support for families at home caring for individuals in prolonged states of reduced consciousness. Hauber, RP., Jones, ML.[2019]

The GOAL Tele-R system demonstrated good feasibility and adherence among patients with Mild Cognitive Impairment (MCI) and Vascular Cognitive Impairment (VCI), with an overall adherence rate of 84% to the proposed activities.

Patients using the Tele-R system had significantly lower drop-out rates compared to those receiving standard care (34% vs. 62%), and participants reported high satisfaction levels, indicating that technology-based rehabilitation can be effective and well-received in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Feasibility, Adherence, and Appreciation of a Newly Developed Tele-Rehabilitation Program for People With MCI and VCI. Mosca, IE., Salvadori, E., Gerli, F., et al.[2023]

A home-based exercise program with telephonic coaching was developed for older adults with Motoric Cognitive Risk syndrome, showing that this approach is safe and feasible for promoting exercise participation.

The program had no adverse effects, and participants rated it highly, indicating that personalized and supervised exercise can effectively overcome barriers to physical activity in cognitively impaired individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. Ambrose, AF., Gulley, E., Verghese, T., et al.[2021]

This study tests a new tele-rehabilitation program designed for individuals with Mild Cognitive Impairment (MCI) and Vascular Cognitive Impairment (VCI), combining cognitive, physical, and social activities over 8 weeks to help prevent cognitive decline.

Involving 60 participants in a randomized controlled trial, the program aims to assess its effectiveness in improving cognitive functioning, physical health, and quality of life compared to a control group, with evaluations at baseline, after the program, and at a 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Games for Older Adults Active Life (GOAL) Project for People With Mild Cognitive Impairment and Vascular Cognitive Impairment: A Study Protocol for a Randomized Controlled Trial. Fabbri, L., Mosca, IE., Gerli, F., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-stroke-sequelae-2-2024-dbab3

Home Telerehabilitation for Vascular Dementia Home telerehabilitation programs have been found to be safe for older adults with cognitive impairments, with no reported adverse effects in studies involving ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8292189/

Telemedicine and Dementia Care: A Systematic Review of ... Among 3 studies using telemedicine for rehabilitation, all studies reported improvement in outcome measures after completing the intervention via telemedicine.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1568163724001028

Effects of home-based and telerehabilitation exercise on ... There is a low evidence on the effects of home-based physical activity or exercise on global cognitive function, neuropsychiatric symptoms and ADL.

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1129914/full

HomeCoRe system for telerehabilitation in individuals at ... The main goal of the present study was to determine usability and user experience of HomeCoRe in individuals at risk of dementia and in their family members.

5. clinconnect.io clinconnect.io/trials/NCT06289569

Home Tele Rehabilitation Therapy for Vascular Dementia This clinical trial is studying a new way to help people who have had a stroke and may also have vascular dementia.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7274219/

Telemedicine: A valuable tool in neurodegenerative diseases These results suggest that telemedicine care provides at least comparable outcomes and may improve some outcomes. Telemedicine care in AD need not be limited ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/13872877241301456

Effects of home-based interventions on cognitive ... Moderate to high evidence shows that home-based interventions significantly improve the cognitive performance of patients with dementia, ...

8. kptjournal.org kptjournal.org/journal/view.html?uid=1687&page=&pn=mostread&sort=publish_Date%20DESC&spage=&vmd=Full

Survey on Tele-Rehabilitation Therapy Awareness Among ... Results: Most of the respondents said that tele-rehabilitation treatment is possible and that it will help with the painful area. They answered ...