Physiotherapy and Deep Brain Stimulation in Parkinson's Disease

NCT04953637 | Active Not Recruiting

• 1 other identifier: 20-6338
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; deep brain stimulation; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Change in mobility measures

  The primary outcome is the overall amount of independent mobility in the community. This will be measured with the Life Space Assessment (LSA) questionnaire. The LSA is a five-item questionnaire where participants are asked to indicate how often within the previous four weeks they moved within their homes, outside their homes but within their property, within their neighborhoods, within their towns, and outside their towns. LSA is a cross-sectional scale that quantifies the size of one's life space in the past 4 weeks as a score of 0-120 (0 = confined to the bedroom, 120 = daily travel to places outside of one's city/town).

  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 (10)

• Balance

  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

• Gait

  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

• Balance confidence

  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

• Number of falls and near falls

  Collected over the 8 months' duration of the study and the diary will be reviewed at visits 2,3,4 and 5.

• Falls risk and functional mobility

  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 (5)

• Exploratory outcome - average number of steps

  7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months

• Exploratory outcome - distance

  7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months

• Exploratory outcome - physically active time

  7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months

Study Arms (2)

Physiotherapy group

EXPERIMENTAL

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.

Other: Physiotherapy

Control group

NO 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.

Interventions

Physiotherapy 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.

Physiotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Movement Disorders Centre - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (32)

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MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Alfonso Fasano, MD, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 8, 2021
• Study Start: April 15, 2021
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)