Physiotherapy and Deep Brain Stimulation in Parkinson's Disease
NCT ID: NCT04953637
Last Updated: 2025-09-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-04-15
Study Completion Date
2025-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Parkinson Disease
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Physiotherapy group
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 Type
EXPERIMENTAL
Physiotherapy
Intervention Type
OTHER
Participants in the physiotherapy group will receive gait and balance focused physiotherapy at One Step Ahead Mobility physiotherapy clinic for 1-hour per day, 3 times/week for 8 weeks.
Control group
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Physiotherapy
Participants in the physiotherapy group will receive gait and balance focused physiotherapy at One Step Ahead Mobility physiotherapy clinic for 1-hour per day, 3 times/week for 8 weeks.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* PD patients who have been identified as candidates for DBS.
* Ability to give informed consent.
* Patients ages 18 years and older.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Toronto
OTHER
Sponsor Role
lead
Responsible Party
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Alfonso Fasano
Professor of Neurology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Alfonso Fasano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Movement Disorders Centre - Toronto Western Hospital
Toronto, Ontario, Canada
Site Status
Countries
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Canada
References
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Reference Type
BACKGROUND
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Lindholm B, Hagell P, Hansson O, Nilsson MH. Prediction of falls and/or near falls in people with mild Parkinson's disease. PLoS One. 2015 Jan 30;10(1):e0117018. doi: 10.1371/journal.pone.0117018. eCollection 2015.
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Pradhan S, Kelly VE. Quantifying physical activity in early Parkinson disease using a commercial activity monitor. Parkinsonism Relat Disord. 2019 Sep;66:171-175. doi: 10.1016/j.parkreldis.2019.08.001. Epub 2019 Aug 3.
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Lamont RM, Daniel HL, Payne CL, Brauer SG. Accuracy of wearable physical activity trackers in people with Parkinson's disease. Gait Posture. 2018 Jun;63:104-108. doi: 10.1016/j.gaitpost.2018.04.034. Epub 2018 Apr 24.
Reference Type
BACKGROUND
Other Identifiers
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20-6338
Identifier Type: -
Identifier Source: org_study_id
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