Physiotherapy and Deep Brain Stimulation for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen byAlfonso Fasano, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Toronto

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Deep brain stimulation (DBS) is the most commonly performed surgical treatment for individuals with Parkinson's disease (PD). DBS typically works best to lessen motor symptoms such as stiffness, slowness, and tremor. Despite an overall improvement of these motor symptoms with DBS, past research failed to show an increase in community mobility and have often reported an increase in falling after surgery. The ability to move around on one's own is important for functional independence and improved quality of life. There is growing evidence supporting the positive effects of physiotherapy on individuals with PD. Gait and balance training, in particular, can improve mobility and also prevent falls. So far, no study has shown the effectiveness of rehabilitation in patients receiving DBS. The purpose of this study is to determine if DBS combined with physiotherapy is effective for improving safe independent mobility in individuals with PD, more so than with patients receiving DBS alone.

Research Team

Alfonso Fasano, MD, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

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

Patients ages 18 years and older.

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).

Treatment Details

Interventions

Deep Brain Stimulation (Procedure)
Physiotherapy (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.

Deep Brain Stimulation is already approved in Canada for the following indications: