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

Trial Summary

What is the purpose of this trial?

To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD)

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 data supports the effectiveness of the treatment Home Tele Rehabilitation Therapy for Vascular Dementia?

Research shows that tele-rehabilitation programs, like the GOAL Tele-R system, are effective for people with cognitive impairments, as they have high adherence rates and participants report cognitive, emotional, and physical benefits. Additionally, similar telerehabilitation approaches have been effective in improving cognitive and physical functions in conditions like Alzheimer's disease and dementia. ^{1 2 3 4 5}

Is home telerehabilitation safe for people with cognitive impairments?

Home telerehabilitation programs have been found to be safe for older adults with cognitive impairments, with no reported adverse effects in studies involving conditions like Motoric Cognitive Risk syndrome and Alzheimer's disease. ^{2 3 6 7 8}

How does Home Tele Rehabilitation Therapy differ from other treatments for vascular dementia?

Home Tele Rehabilitation Therapy is unique because it uses remote communication technologies to deliver rehabilitation services at home, making it accessible for patients who cannot attend face-to-face sessions. This approach is particularly beneficial for engaging patients in multi-dimensional activity programs, ensuring continuity of care, and providing a cost-effective solution compared to traditional methods. ^{2 3 9 10 11}

Research Team

Timea Hodics, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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

I can give my consent, or someone legally authorized can on my behalf.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Lessons learned: feasibility and acceptability of a telehealth-delivered exercise intervention for rural-dwelling individuals with dementia and their caregivers. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of Feasibility, Adherence, and Appreciation of a Newly Developed Tele-Rehabilitation Program for People With MCI and VCI. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of motor-cognitive dual-task exercise via telerehabilitation in Alzheimer's disease: An online pilot randomized controlled study. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

The Effect of Computer-Assisted Cognitive Remediation Therapy on Cognitive Function, Social Function and Quality of Life in Patients with Vascular Dementia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Rehabilitation of persons with dementia: using technology to improve participation. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. [2021]

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

Effectiveness of home-based telerehabilitation in mild to moderate Alzheimer's disease: A randomised controlled study. [2022]

8. Switzerland 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. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Stroke Telerehabilitation in Calabria: A Health Technology Assessment. [2022]

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

Telerehabilitation Approaches for Stroke Patients: Systematic Review and Meta-analysis of Randomized Controlled Trials. [2022]

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

Telerehabilitation support for families at home caring for individuals in prolonged states of reduced consciousness. [2019]