Physiotherapy and Deep Brain Stimulation in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Combined Physiotherapy and Deep Brain Stimulation to Improve Independent Community Mobility in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953637
• Other study ID #: 20-6338
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: October 2022
• Source: University of Toronto
• Contact: Alfonso Fasano, MD, PhD
• Phone: (416) 603-5800
• Email: alfonso.fasano[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Canada	Movement Disorders Centre - Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome - average number of steps	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.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Other	Exploratory outcome - distance	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.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Other	Exploratory outcome - physically active time	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.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Other	Exploratory outcome - heart rate	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.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Other	Exploratory outcome - sleep quality	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.	7 days of activity monitoring before the pre-intervention assessment at 3 months and the post-intervention assessment at 6 months
Primary	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	Balance	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).	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
Secondary	Gait	Dynamic stability during walking, spatio-temporal gait variability and walking speed will be evaluated using the gait mat Zeno Walkway (ProtoKinetics, Havertown, PA, USA).	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
Secondary	Balance confidence	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.	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
Secondary	Number of falls and near falls	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.	Collected over the 8 months' duration of the study and the diary will be reviewed at visits 2,3,4 and 5.
Secondary	Falls risk and functional mobility	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.	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
Secondary	Mood	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.	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
Secondary	Anxiety	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.	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
Secondary	Exercise and activity levels	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.	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
Secondary	Health-related quality of life	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.	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
Secondary	Parkinson's disease symptoms	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.	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