Physiotherapy and Deep Brain Stimulation for Parkinson's Disease

Overseen By Alfonso Fasano, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Orthopaedic conditions, Severe cognitive deficits, Physiotherapy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 29

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining deep brain stimulation (DBS) with physiotherapy enables people with Parkinson's disease to move more safely and independently than using DBS alone. DBS, a surgical treatment, reduces stiffness, slowness, and tremors but has not improved overall mobility or reduced falls. Physiotherapy, particularly gait and balance training, might enhance mobility and prevent falls. The trial seeks participants approved for DBS who can give consent and are not currently undergoing physiotherapy. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance treatment options for Parkinson's disease.

Will I have to stop taking my current medications?

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 deep brain stimulation and physiotherapy are safe for individuals with Parkinson's disease?

Research has shown that physiotherapy can help people with Parkinson's disease in the short term. However, the most effective type of physiotherapy remains unclear. While physiotherapy is generally safe, its effects can vary from person to person.

Deep brain stimulation (DBS) is a well-known surgery used to reduce movement problems like stiffness and tremors in people with Parkinson's disease. DBS has been used for many years, and studies have shown it to be safe. However, while DBS can help with movement issues, it might not improve walking in everyday situations, and there could be a higher chance of falling after the surgery.

Both physiotherapy and DBS are considered safe treatments. However, as with any treatment, results can vary for each person. It's important to discuss personal risks and benefits with healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combined approach of physiotherapy and Deep Brain Stimulation (DBS) for Parkinson's disease because it offers a new way to enhance patient outcomes. DBS is unique as it involves implanting electrodes in specific brain areas to modulate abnormal activity, which can lead to significant improvements in motor symptoms. While traditional treatments like medication primarily manage symptoms, DBS combined with tailored physiotherapy could optimize movement and quality of life by addressing both neurological and physical aspects. This dual approach has the potential to offer more comprehensive benefits compared to standard treatments alone.

What evidence suggests that combining deep brain stimulation with physiotherapy might be effective for improving mobility in Parkinson's disease?

Research has shown that deep brain stimulation (DBS) reduces movement problems like stiffness, slowness, and tremors in people with Parkinson's disease. However, it has not always improved patients' daily movement. This trial will compare the effects of physiotherapy and a control condition in patients who have undergone DBS. Physiotherapy has been shown to enhance movement and walking ability in people with Parkinson's. Studies have found that different types of physiotherapy, such as strength training and treadmill exercises, can significantly improve walking and quality of life. Although no study has directly tested physiotherapy in patients who have had DBS, existing evidence suggests that physiotherapy could complement DBS to improve movement and reduce falls. ^{1 2 5 6 7}

Who Is on the Research Team?

Alfonso Fasano, MD, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Parkinson's Disease who are candidates for Deep Brain Stimulation (DBS) surgery and can consent to participate. It excludes those already in physiotherapy, with orthopedic issues affecting mobility, or severe cognitive deficits (MoCA score <17).

Inclusion Criteria

PD patients who have been identified as candidates for DBS.

Ability to give informed consent.

Exclusion Criteria

Participants who are already receiving physiotherapy treatment (or that has been receiving it during the three months prior to enrollment) will be excluded from the study.

Participants will be excluded if they have ongoing orthopaedic conditions potentially impacting on global mobility.

Participants with severe cognitive deficits ((Montreal Cognitive Assessment (MoCA) score <17).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DBS Surgery and Optimization

Participants undergo DBS surgery and optimization of DBS settings

3 months

3 visits (in-person)

Treatment

Participants in the physiotherapy group receive gait and balance focused physiotherapy for 8 weeks, while the control group receives no intervention

8 weeks

24 visits (in-person) for physiotherapy group

Post-intervention Assessment

All participants undergo assessments to evaluate the effects of the intervention

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation
• Physiotherapy

Trial Overview The study tests if combining DBS with physiotherapy improves independent mobility and reduces falls better than DBS alone in Parkinson's patients. The effectiveness of gait and balance training post-DBS will be evaluated.

How Is the Trial Designed?

Group I: Physiotherapy group Experimental Treatment 1 Intervention

Participants assigned to the physiotherapy group will receive physiotherapy treatment at One Step Ahead Mobility physiotherapy clinic for 1-hour per day, 3 times/week for 8 weeks. They will begin to receive the physiotherapy treatment at 4 months following their surgery and once their DBS settings are optimized.

Group II: Control group Active Control 1 Intervention

Participants assigned to the control group will not receive any additional intervention and will be precluded from starting formal physiotherapy for the duration of the study. However, they will be encouraged to keep an active lifestyle. In order to stay active, they will be recommended to do simple home exercises following a home exercise video that will be presented to them. They will be asked to do it 3 times/week for 8 weeks and keep an exercise log to help them stay on track.

Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain
• Stroke-related motor deficits (under investigation)

Approved in European Union as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Approved in Canada as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Citations

1. academic.oup.com academic.oup.com/ptj/article/99/2/203/5298162

Comparative Effectiveness of mHealth-Supported Exercise ... The purpose of this study was to explore the preliminary effectiveness, safety, and acceptability of a mobile health (mHealth)–mediated exercise program

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7120367/

Physiotherapy for Parkinson's disease: a comparison of ... Trials have shown that physiotherapy has short‐term benefits in PD. However, which physiotherapy intervention is most effective remains unclear.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32917125/

Physiotherapy in Parkinson's Disease: A Meta-Analysis of ... Conventional physiotherapy significantly improved motor symptoms, gait, and quality of life. Resistance training improved gait. Treadmill training improved gait ...

4. researchgate.net researchgate.net/publication/381360417_Early_and_Long-Term_Effects_of_Comprehensive_Pelvic_Physiotherapy_on_Autonomic_Disorders_in_Parkinson's_Disease_A_case_report

Early and Long-Term Effects of Comprehensive Pelvic ... The purpose of this case report is to assess the early and long-term effects of comprehensive pelvic physiotherapy on autonomic dysfunction in a ...

5. scholarworks.calstate.edu scholarworks.calstate.edu/downloads/m326m2745

THE EFFECTS OF PELVIC FLOOR MUSCLE TRAINING ... Review of Meta-Analysis Results. This meta-analysis demonstrated that PFMT is an effective means of improving PFM strength and quality of life in individuals ...

6. journals.lww.com journals.lww.com/jwphpt/fulltext/2025/01001/csm_2025_abstracts__2025_apta_combined_sections.1.aspx

CSM 2025 Abstracts: 2025 APTA Combined Sections ... Findings show PFMT improves BSS, LE., and QOL in males, addressing a gap left by female-specific studies. However, the effects remain unclear due to small ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451865417300480

Supervised pelvic floor muscle training versus attention ... The aim of this trial is to investigate if 16 weeks of supervised pelvic floor muscle training in combination with conservative treatment is superior to ...