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Physiotherapy and Deep Brain Stimulation for Parkinson's Disease

N/A

Waitlist Available

Led By Alfonso Fasano, MD, PhD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1: baseline assessment at month 0, visit 2: pre-intervention assessment at month 3, visit 4: post-intervention assessment at month 6, and visit 5: end of study assessment at month 8

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding physical therapy to standard deep brain stimulation surgery helps improve mobility for people with Parkinson’s disease, beyond what surgery alone can achieve.

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

While not explicitly stated, potential side effects may include typical risks associated with physiotherapy such as muscle soreness or fatigue, and those related to DBS like infection risk at the surgical site or changes in mood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1: baseline assessment at month 0, visit 2: pre-intervention assessment at month 3, visit 4: post-intervention assessment at month 6, and visit 5: end of study assessment at month 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1: baseline assessment at month 0, visit 2: pre-intervention assessment at month 3, visit 4: post-intervention assessment at month 6, and visit 5: end of study assessment at month 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1: baseline assessment at month 0, visit 2: pre-intervention assessment at month 3, visit 4: post-intervention assessment at month 6, and visit 5: end of study assessment at month 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mobility measures

Secondary study objectives

Anxiety

Balance

Balance confidence

+7 more

Other study objectives

Exploratory outcome - average number of steps

Exploratory outcome - distance

Exploratory outcome - heart rate

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Physiotherapy groupExperimental Treatment1 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 groupActive Control1 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.

Do I qualify?Apply below to find out