Physiotherapy and Deep Brain Stimulation in Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT04953637
• Recruitment Status: Recruiting
• First Posted: July 8, 2021
• Last Update Posted: November 3, 2022
• Sponsor: University of Toronto
• Information provided by (Responsible Party): Alfonso Fasano, University of Toronto

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Other: Physiotherapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Combined Physiotherapy and Deep Brain Stimulation to Improve Independent Community Mobility in Parkinson's Disease
• Actual Study Start Date: April 15, 2021
• Estimated Primary Completion Date: October 31, 2023
• Estimated Study Completion Date: October 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in mobility measures [ Time Frame: 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 ]
   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).

Secondary Outcome Measures :

1. Balance [ Time Frame: 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 ]
   The Mini Balance Evaluation Systems Test (Mini-BESTest) will be used to measure dynamic balance. The Mini-BESTest is a 14-item test that includes four sections: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 indicates that a person is unable to perform the task while a score of 2 is normal).
2. Gait [ Time Frame: 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 ]
   Dynamic stability during walking, spatio-temporal gait variability and walking speed will be evaluated using the gait mat Zeno Walkway (ProtoKinetics, Havertown, PA, USA).
3. Balance confidence [ Time Frame: 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 will be assessed using the Activity-specific Balance Confidence (ABC) scale. The ABC asks participants to rate, on a scale from 0-100%, how confident they would be performing 16 everyday tasks.
4. Number of falls and near falls [ Time Frame: Collected over the 8 months' duration of the study and the diary will be reviewed at visits 2,3,4 and 5. ]
   Participants will be provided with a diary on enrolment into the study and will be asked to record any falls and near falls that they experience over the 8 months' duration of the study. A fall is defined as an event that result in a person coming to rest inadvertently on the ground or other lower level not due to a major intrinsic or extrinsic event. If a participant sustains a fall, they will be asked to record the details about the circumstances surrounding the fall with an open-ended questionnaire (setting, activity at the time of fall, physical injury, emergency department visit, hospitalization) in the falls diary. A near fall is defined as stumbling or loss of balance that would result in falling if sufficient recovery mechanisms were not activated. If the participant had a near fall, they will be asked to record the details about the event using the same open-ended questionnaire (setting, activity at the time of near fall, how the fall was avoided) in the diary.
5. Falls risk and functional mobility [ Time Frame: 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 ]
   The Timed Up and Go test (TUG) will be used to assess the falls risk and functional mobility. The TUG test is a physical performance measure in which the ability to rise up from a seated chair position, walk 3m, turn, walk back, and sit down is timed. The TUG test is highly correlated with functional mobility, gait speed, and falls in older adults.
6. Mood [ Time Frame: 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 ]
   Mood will be assessed using the Beck Depression Inventory (BDI-I).The BDI-I is a 21-item questionnaire to assess depressive symptoms with a score of 0-3 for each item.
7. Anxiety [ Time Frame: 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 ]
   The Hamilton Anxiety Rate Scale (HAM-A) will be used to measure the anxiety symptoms. The scale consists of 14 items with a score of 0-4 for each item.
8. Exercise and activity levels [ Time Frame: 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 ]
   Exercise and activity levels will be monitored through a set of questions about how much exercise or physical activity they do on a regularly. For the intensity of the activity, they will be asked to separate how much time they spend doing vigorous, moderate, and light activity.
9. Health-related quality of life [ Time Frame: 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 ]
   Health-related quality of life will be assessed using the 39-item Parkinson's Disease Questionnaire (PDQ-39). The PDQ-39 asks participants to rate how often they encounter difficulty on items within eight subscales: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.
10. Parkinson's disease symptoms [ Time Frame: 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 ]
    Parkinson's disease symptoms will be evaluated with the Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 3 scores. The maximum total MDS-UPDRS score for part 3 ranges from 0 to 132. Higher scores indicate a worse outcome of Parkinson's disease.

Other Outcome Measures:

1. Exploratory outcome - average number of steps [ Time Frame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months ]
   A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure the average number of steps (the total number of steps per day averaged over the number of days worn). The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.
2. Exploratory outcome - distance [ Time Frame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months ]
   A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure the distance (kilometers). The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.
3. Exploratory outcome - physically active time [ Time Frame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months ]
   A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure the time being physically active. The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.
4. Exploratory outcome - heart rate [ Time Frame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months ]
   A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure the heart rate (rates per minute). The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.
5. Exploratory outcome - sleep quality [ Time Frame: 7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months ]
   A wearable activity monitor Fitbit Inspire 2 (Fitbit Inc., San Francisco, CA, USA) will be used to measure sleep quality (minutes). The participants will be provided with a Fitbit Inspire 2 activity monitor before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months. They will be instructed to wear the activity monitor on their wrist for 7 days including during sleep before the assessment visits.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Alfonso Fasano, MD, PhD; (416) 603-5800 ext 5961; alfonso.fasano@uhn.ca

Contact: Sumi Rajalingam, MD, Hon. BSc; (416) 603-5800 ext 3158; rajasumi.rajalingam@uhnresearch.ca

Locations

Canada, Ontario

Movement Disorders Centre - Toronto Western Hospital; Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contact: Alfonso Fasano, MD, PhD (416) 603-5800 ext 5961 alfonso.fasano@uhn.ca

Contact: Sumi Rajalingam, MD, Hon. BSc (416) 603-5800 ext 3158 rajasumi.rajalingam@uhnresearch.ca

Principal Investigator: Alfonso Fasano, MD, PhD

Sponsors and Collaborators

University of Toronto

Investigators

• Principal Investigator: Alfonso Fasano, MD, PhD; University of Toronto

More Information

Publications:

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• Responsible Party: Alfonso Fasano, Professor of Neurology, University of Toronto
• ClinicalTrials.gov Identifier: NCT04953637
• Other Study ID Numbers: 20-6338
• First Posted: July 8, 2021
• Last Update Posted: November 3, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alfonso Fasano, University of Toronto:

Parkinson disease; deep brain stimulation; physiotherapy

Additional relevant MeSH terms:

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