Telemedicine Intervention for Chronic Pain in Parkinson's Disease

Overseen by David William Sparrow, DSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Must be taking: Dopaminergic medication

Disqualifiers: Angina, Recent MI, Ventricular dysrhythmia

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests home-based physical and mental exercises to reduce pain in Veterans with Parkinson's disease. The exercises aim to make the body stronger and the mind more focused, helping to lessen the feeling of pain.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves exercise interventions and not medication changes, you may not need to stop your current medications.

What data supports the effectiveness of the treatment Telemedicine Intervention for Chronic Pain in Parkinson's Disease?

Research shows that home-based physical and cognitive exercises, supported by telehealth, can improve motor skills, cognitive function, and quality of life in Parkinson's patients. Telerehabilitation programs have been effective in increasing adherence to exercise and improving mobility and confidence, even in remote settings. ^{1 2 3 4 5}

Is telemedicine intervention for chronic pain in Parkinson's disease safe?

Research on home-based exercise programs and telerehabilitation for Parkinson's disease shows that these interventions are generally safe, with no reported adverse effects. They are feasible and well-received by participants, improving adherence and quality of life. ^{1 2 6 7 8}

How is the telemedicine intervention for chronic pain in Parkinson's disease different from other treatments?

This treatment is unique because it combines cognitive and physical exercises that patients can do at home, using telemedicine to provide remote support and guidance. This approach helps overcome barriers like travel costs and time, making it more accessible and convenient, especially during situations like the COVID-19 pandemic. ^{1 3 5 6 9}

Research Team

David William Sparrow, DSc

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Eligibility Criteria

This trial is for individuals with Parkinson's Disease who experience chronic pain. Participants must have a physician's diagnosis of idiopathic PD, show at least two key symptoms (resting tremor, rigidity, or slow movement), and respond to medication that increases dopamine. It excludes those with recent heart issues like angina or myocardial infarction within the last six months.

Inclusion Criteria

My condition improves with dopamine medication.

I have been diagnosed with Parkinson's disease by a doctor.

I show at least 2 key symptoms of Parkinson's disease.

Exclusion Criteria

I am currently being treated for irregular heartbeats.

I have had a heart attack in the last 6 months.

I have chest pain due to heart problems.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cognitive exercise, physical exercise, combined interventions, or health education for 3 months

3 months

Remote access technology used for interventions

Follow-up

Participants are monitored for changes in pain severity after treatment

3 months

Treatment Details

Interventions

• Cognitive exercise intervention (Cognitive Intervention)
• Health education (Education Intervention)
• Physical exercise intervention (Exercise Intervention)

Trial Overview The study tests home-based physical and cognitive exercises along with health education as interventions to reduce pain in Parkinson's patients using telemedicine. This could help veterans maintain these practices indefinitely through remote access technology.

Participant Groups

Group I: Physical exercise intervention Experimental Treatment 1 Intervention

Participants will receive the physical exercise intervention for 3 months.

Group II: Combined physical and cognitive exercise intervention Experimental Treatment 2 Interventions

Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months.

Group III: Cognitive exercise intervention Experimental Treatment 1 Intervention

Participants will receive the cognitive exercise intervention for 3 months.

Group IV: Control group Active Control 1 Intervention

Participants will receive health education for 3 months.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

A novel telerehabilitation program using a treadmill-virtual reality system for patients with Parkinson's disease showed high adherence to training and significant improvements in walking duration, gait speed, and overall mobility over a year-long period.

The program allowed simultaneous training of two patients at home, which not only enhanced individual treatment but also saved time for therapists, making it a practical solution for maintaining exercise adherence during challenges like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Rehabilitation with Virtual Reality: A Case Report on the Simultaneous, Remote Training of Two Patients with Parkinson Disease. Cornejo Thumm, P., Giladi, N., Hausdorff, JM., et al.[2023]

The STEPS trial will evaluate the effectiveness of a 10-week eHealth-supported motor-cognitive training program for 120 participants with mild to moderate Parkinson's disease, focusing on improving walking capacity compared to a standard paper-based exercise program.

The primary outcome measured will be walking capacity using the six-minute walk test, with additional assessments on gait performance, mobility, and patient-reported outcomes, aiming to provide evidence for the efficacy of eHealth interventions in managing Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the STEPS trial: a phase II randomized controlled trial evaluating eHealth-supported motor-cognitive home training for Parkinson's disease. Leavy, B., Sedhed, J., Kalbe, E., et al.[2023]

A telerehabilitation program for Parkinson's disease was found to be feasible and effective, showing high adherence and minimal adverse effects among 19 participants in the Brazilian Amazon over a 4-week period.

Both the telerehabilitation and a control booklet-based exercise program improved participants' performance on the Timed Up and Go test, indicating that remote physiotherapy can be a valuable alternative for those with limited access to traditional rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of a remote individual rehabilitation program for people with Parkinson's disease living in the Brazilian Amazon: a randomized clinical trial. Pastana Ramos, LF., Vilacorta-Pereira, TCS., Duarte, JDS., et al.[2023]

In a study of 58 participants with Parkinson's disease, individualized physical therapy significantly improved physical performance and balance compared to home exercise programs and group classes, highlighting the importance of supervision in exercise interventions.

While group classes enhanced gait performance, the home exercise program was the least effective overall, especially for individuals with comorbidities, suggesting that tailored, supervised exercise is crucial for maximizing benefits in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. King, LA., Wilhelm, J., Chen, Y., et al.[2018]

A telerehabilitation protocol involving 40 participants with mild to moderate Parkinson's disease was successfully implemented, demonstrating its feasibility and effectiveness as an alternative to in-person physical therapy during the COVID-19 pandemic.

The intervention included 20 remote weekly sessions focusing on physical and cognitive training, which helped minimize negative impacts on functional strength, quality of life, and mental health in patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth For Individuals with Parkinson's Disease During Covid-19 In Brazil: A Prospective Case Series. Barboza, NM., de Oliveira Araújo, HAG., Terra, MB., et al.[2023]

A digital, home-based exercise program for 16 patients with Parkinson's disease showed high adherence (74.5%) and excellent usability, indicating that patients found the smartphone app easy to use and beneficial for their training.

After 6-8 months, patients using the app experienced improvements in their daily motor activities, while the control group showed a decline in motor function, suggesting that this digital exercise approach can effectively complement traditional medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of an individualized smartphone-based exercise program on self-defined motor tasks in Parkinson's disease: a long-term feasibility study. Lützow, L., Teckenburg, I., Koch, V., 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]

Telerehabilitation is a feasible and effective option for managing both motor symptoms (like gait and balance) and non-motor symptoms (such as speech disorders) in patients with Parkinson's disease, based on a systematic review of 15 studies involving 421 patients.

The review also indicated that telerehabilitation can improve quality of life and patient satisfaction, suggesting it is a valuable alternative to traditional in-person therapy for those with limited access to specialist care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Telerehabilitation on Motor Impairments, Non-motor Symptoms and Compliance in Patients With Parkinson's Disease: A Systematic Review. Vellata, C., Belli, S., Balsamo, F., et al.[2021]

A study involving 57 participants in a supervised, home-based telerehabilitation program for 10 months showed that this approach effectively preserved quality of life and walking ability in people with Parkinson's disease during social distancing.

In contrast, a nonexercising control group of 29 participants experienced worsening in all assessed clinical aspects, highlighting the benefits of continued exercise through telerehabilitation for frequent exercisers with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation during social distancing for people with Parkinson's disease: a retrospective study. Tardelli, E., Moreira-Neto, A., Okamoto, E., et al.[2023]

References

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

Tele-Rehabilitation with Virtual Reality: A Case Report on the Simultaneous, Remote Training of Two Patients with Parkinson Disease. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Design of the STEPS trial: a phase II randomized controlled trial evaluating eHealth-supported motor-cognitive home training for Parkinson's disease. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of a remote individual rehabilitation program for people with Parkinson's disease living in the Brazilian Amazon: a randomized clinical trial. [2023]

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

Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. [2018]

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

Telehealth For Individuals with Parkinson's Disease During Covid-19 In Brazil: A Prospective Case Series. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

The effects of an individualized smartphone-based exercise program on self-defined motor tasks in Parkinson's disease: a long-term feasibility study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Telerehabilitation on Motor Impairments, Non-motor Symptoms and Compliance in Patients With Parkinson's Disease: A Systematic Review. [2021]

9. Italy pubmed.ncbi.nlm.nih.gov

Telerehabilitation during social distancing for people with Parkinson's disease: a retrospective study. [2023]