Clinical trial NCT04953637: Physiotherapy and Deep Brain Stimulation in Parkinson's Disease
Official title: Combined Physiotherapy and Deep Brain Stimulation to Improve Independent Community Mobility in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
deep brain stimulation
physiotherapy
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a single-center, single-blind non-randomized controlled study, whereby individuals receiving DBS will be allocated to receive either physiotherapy or no intervention in keeping with current practice (control group).

Patients will be recruited from a pool of PD patients who have been identified as candidates for DBS in the Movement Disorders Clinics at the Toronto Western Hospital. Approximately 60 individuals will be recruited for the study. Study participation will span 8 months from the time of enrolment to the end of the study assessment.

Participants will be allocated to one of two groups: 1) physiotherapy, or 2) control. Participants living within 50 km of the physiotherapy clinic will be allocated to the physiotherapy group and those living beyond 50 km will be allocated to the control group. Participants assigned to the physiotherapy group will receive physiotherapy treatment at the One Step Ahead Mobility physiotherapy clinic for 1 hour per day, 3 times/week for 8 weeks. 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. Participants assigned to the control group will be assessed at the same points in time as participants in the physiotherapy group

All participants enrolled will undergo a similar timetable with assessments completed at five points throughout the study period. At month 0, participants are enrolled in the study, have their baseline assessment completed, and receive DBS surgery. At month 1, participants are started on optimization of DBS settings. At month 3, DBS settings are optimized and participants will have completed 7 days of activity monitoring using a wearable before the pre-intervention assessment. All participants are assessed before the physiotherapy group begins to receive gait and balance focused physiotherapy for 2 months (8 weeks) and the control group receives no intervention for 2 months. At month 5, physiotherapy is completed, and all participants undergo a third assessment immediately after the intervention period. At month 6, all participants are assessed with a Life Space Assessment questionnaire post-intervention and will have completed 7 days of activity monitoring using a wearable before the visit. At month 8, all participants undergo end of study assessment 3 months after completing physiotherapy.

Eligibility criteria: Inclusion Criteria:

* PD patients who have been identified as candidates for DBS.
* Ability to give informed consent.
* Patients ages 18 years and older.

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
measure: Change in mobility measures
timeFrame: 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
Secondary outcomes:
measure: Balance
timeFrame: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
measure: Gait
timeFrame: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
measure: Balance confidence
timeFrame: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
measure: Number of falls and near falls
timeFrame: Collected over the 8 months' duration of the study and the diary will be reviewed at visits 2,3,4 and 5.
measure: Falls risk and functional mobility
timeFrame: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
measure: Mood
timeFrame: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
measure: Anxiety
timeFrame: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
measure: Exercise and activity levels
timeFrame: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
measure: Health-related quality of life
timeFrame: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
measure: Parkinson's disease symptoms
timeFrame: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 3: Post-intervention assessment at month 5, and Visit 5: End of study assessment at month 8
Other outcomes:
measure: Exploratory outcome - average number of steps
timeFrame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
measure: Exploratory outcome - distance
timeFrame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
measure: Exploratory outcome - physically active time
timeFrame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
measure: Exploratory outcome - heart rate
timeFrame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
measure: Exploratory outcome - sleep quality
timeFrame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Locations:
city: Toronto
country: Canada
facility: Movement Disorders Centre - Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Alfonso Fasano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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