Balance Tele-Rehab for Parkinson's Disease

Overseen By Martina Mancini, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must be taking: Levodopa

Disqualifiers: Epilepsy, Stroke, Dementia, others

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

Compensation: Varies

Number of Visits: 20

Duration: 4 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of balance exercises at home, assisted by a physical therapist via video calls, for people with Parkinson's disease who have balance issues. Participants are divided into two groups: one receives virtual sessions with a therapist, while the other follows the exercise program independently. The trial seeks individuals with Parkinson's who have balance problems, do not fall more than three times a week, and can follow exercise instructions. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance balance management for Parkinson's patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it asks participants to refrain from making changes to their medications during the study period, as reasonable.

What prior data suggests that this tele-rehabilitation method is safe for people with Parkinson's disease?

Research has shown that the Balance Tele-Rehabilitation Agility Boot Camp (ABC) is generally manageable for people with Parkinson's disease. Studies have found that this exercise program can improve balance and walking, which are often challenging for those with Parkinson's. Participants reported feeling more balanced and independent. These studies identified no major safety concerns, indicating that the program is safe for most people. The use of wearable sensors to track progress is effective and non-invasive. Overall, this treatment appears to be a safe option for those seeking to improve their balance at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Balance Tele-Rehabilitation for Parkinson's Disease because it offers a unique at-home approach to improving mobility. Unlike traditional in-person physical therapy, this method uses tele-rehabilitation, allowing participants to engage in supervised virtual sessions with a physical therapist. Additionally, the trial includes an assessment with wearable sensors to monitor daily life mobility, providing real-time feedback and a personalized exercise experience. This innovative approach could make rehabilitation more accessible and adaptable to individual needs, potentially enhancing patient outcomes compared to standard care options like in-clinic therapy sessions.

What evidence suggests that Balance Tele-Rehabilitation Agility Boot Camp (ABC) is effective for balance disorders in Parkinson's disease?

Research has shown that the Balance Tele-Rehabilitation Agility Boot Camp (ABC) can help people with Parkinson's disease improve their balance and gait. Earlier studies addressed specific balance problems and reduced the impact of cognitive tasks on walking. Participants reported feeling more independent and experiencing a better quality of life. Improvements appeared in individuals both with and without freezing of gait (FoG), a common Parkinson's symptom. This trial will compare two approaches: one group will participate in supervised tele-rehabilitation home exercise with a physical therapist, while another group will engage in unsupervised rehabilitation home exercise. These findings suggest that the ABC program could effectively manage balance issues in people with Parkinson's. ^{1 2 6 7 8}

Who Is on the Research Team?

Laurie A King, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for people aged 55-85 with Parkinson's disease who can follow directions and participate in exercise. They should be responsive to levodopa, at stages I-III of the disease, and able to commit to a rehab program 3 times a week for 4 weeks without changing medications or other exercises.

Inclusion Criteria

I am between 55 and 85 years old.

My Parkinson's disease is in the early to mid stages.

Ability to follow directions in order to participate in testing procedures and exercise classes

Exclusion Criteria

Excessive use of alcohol or recreational drugs

Cognitive inability to participate in an exercise program, such as MoCA score less than or equal to 19, prior diagnosis of dementia or inability to follow directions

No medical condition that precludes exercise

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Virtual Balance Assessment

Participants undergo a virtual balance assessment using wearable sensors to predict clinical balance assessment outcomes

1 week

1 visit (virtual)

Treatment

Participants engage in either supervised tele-rehabilitation or unsupervised home exercise for balance improvement

4 weeks

12 visits (virtual for supervised group)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including daily life mobility assessment

1 week

7 days of monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Balance Tele-Rehabilitation Agility Boot Camp (ABC)

Trial Overview The study tests the effectiveness of Balance Tele-Rehabilitation Agility Boot Camp (ABC) delivered remotely for improving balance in Parkinson's patients. It aims to assess if this method is feasible as a treatment option.

How Is the Trial Designed?

Group I: Supervised Tele-Rehabilitation Home Exercise Experimental Treatment 1 Intervention

40 participants will have tele-rehabilitation virtually with a physical therapist for 60 minutes approximately three times per week for four weeks of intervention (12 visits). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors.

Group II: Unsupervised Rehabilitation Home Exercise Active Control 1 Intervention

40 participants will complete their home exercise Agility Boot Camp (ABC) program for 60 minutes approximately three times per week for four weeks of intervention (12 sessions). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

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

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]

The 'ParkinDANCE Online' program, involving 12 participants with Parkinson's disease, demonstrated strong feasibility and safety, with no dropouts or adverse events reported during the 6-week online dance classes.

The program was well-received, with 100% attendance and positive feedback from both participants and dance instructors, indicating that online dancing can be an engaging and effective physical activity for individuals with early Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dancing for Parkinson's Disease Online: Clinical Trial Process Evaluation. Morris, ME., McConvey, V., Wittwer, JE., et al.[2023]

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]

Exercise and rehabilitation programs become essential for Parkinson's disease patients when motor decline occurs despite DOPAtherapy, as they can help reduce daily life disability rather than directly improving core symptoms like bradykinesia or tremor.

Only a few well-designed studies exist on the effectiveness of rehabilitation in Parkinson's disease, but they suggest that early intervention with physiotherapy focusing on postural control and fall prevention can significantly benefit patients' independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercices program and rehabilitation of motor disorders in Parkinson's disease]. Pélissier, J., Pérennou, D.[2006]

A telerehabilitation approach to group tango classes for people with Parkinson disease (PD) was found to be feasible, with high participant retention (85%) and attendance (87%).

Both telerehabilitation and in-person instruction led to significant improvements in balance and motor sign severity over 12 weeks, indicating that telerehabilitation can be as effective as traditional in-person classes for enhancing motor function in PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a telerehabilitation approach to group adapted tango instruction for people with Parkinson disease. Seidler, KJ., Duncan, RP., McNeely, ME., et al.[2018]

In a study of 76 patients with Parkinson's disease, home-based virtual reality (VR) balance training significantly improved postural stability compared to in-clinic sensory integration balance training, as measured by the Berg Balance Scale.

Both training methods were effective over time, but VR telerehabilitation offers a feasible alternative for patients, especially those with caregivers, while also potentially reducing treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Telerehabilitation for Postural Instability in Parkinson's Disease: A Multicenter, Single-Blind, Randomized, Controlled Trial. Gandolfi, M., Geroin, C., Dimitrova, E., et al.[2022]

The TelePD Trial aims to assess the effectiveness of virtual balance assessments and telerehabilitation for people with Parkinson's disease, involving 80 participants who will undergo 12 sessions of either balance telerehabilitation or unsupervised exercises.

This study will be the first to evaluate how well wearable sensors can measure balance and gait remotely, potentially leading to improved home-based rehabilitation strategies for individuals with balance impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance telerehabilitation and wearable technology for people with Parkinson's disease (TelePD trial). Silva-Batista, C., Wilhelm, JL., Scanlan, KT., et al.[2023]

A 6-week Agility Boot Camp with Cognitive Challenges (ABC-C) intervention for 86 individuals with Parkinson's disease showed that objective measures of balance and gait, particularly gait speed during dual-task walking and anticipatory postural adjustments, were more sensitive to change than clinical measures after the exercise intervention.

The most responsive clinical measure was the patient-reported PDQ-39 activities of daily living subscore, indicating that while patients felt more functionally independent, objective measures provided clearer evidence of improvement in balance and gait.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsiveness of Objective vs. Clinical Balance Domain Outcomes for Exercise Intervention in Parkinson's Disease. Hasegawa, N., Shah, VV., Harker, G., et al.[2020]

Both the Agility Boot Camp and treadmill training programs improved mobility in people with Parkinson's disease, with significant changes in measures like stride velocity and peak arm speed after 4 weeks of exercise.

The Agility Boot Camp specifically showed a greater improvement in postural sway compared to treadmill training, indicating that certain exercise types may offer unique benefits for mobility in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring outcome measures for exercise intervention in people with Parkinson's disease. King, LA., Salarian, A., Mancini, M., et al.[2022]

Citations

1. nature.com nature.com/articles/s41531-020-00132-z

Effects of the agility boot camp with cognitive challenge ... The ABC-C exercise intervention can improve specific balance deficits, cognitive-gait interference, and perceived functional independence and quality of life.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05680597

Balance Tele-Rehab in Parkinson's Disease ... This project consists of a virtual balance assessment which will use objective measures of balance and gait obtained with wearable sensors on the feet and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10571293/

Balance telerehabilitation and wearable technology for ... This trial will enroll 80 eligible people with PD. Participants will be randomized at a 1:1 ratio into receiving home-based balance exercises.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11561861/

Effects of a Cognitively Challenging Agility Boot Camp ... The ABC-C program was effective in improving gait performance in both PD−FoG and PD+FoG, even after controlling for disease duration.

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/1545968320909331

Cognitively Challenging Agility Boot Camp Program for ... Improvements after exercise, revealed by moderate and large effect sizes, were observed for subject perception of FoG after exercise, dual-task ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36004814/

Does Freezing of Gait Status Matter? - PubMed - NIH This study aimed to determine whether both people with and without FoG benefit from the Agility Boot Camp with Cognitive Challenges (ABC-C) ...

7. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/counter/pdf/10.1186/s12883-023-03403-3.pdf?utm_source=consensus

Balance telerehabilitation and wearable technology for ... Clinical Balance Domain Outcomes for Exercise Intervention in Parkinson's Disease. ... Effects of the agility boot camp with cognitive challenge (ABC‑C) exercise ...

8. researchgate.net researchgate.net/publication/374721985_Balance_telerehabilitation_and_wearable_technology_for_people_with_Parkinson's_disease_TelePD_trial

(PDF) Balance telerehabilitation and wearable technology ... Conclusion The TelePD Trial will be the first to explore the usefulness of using wearable sensor-based measures of balance and gait remotely to assess balance, ...