Physical Therapy and Deep Brain Stimulation in Parkinson Disease (PTDBS)
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|ClinicalTrials.gov Identifier: NCT03181282|
Recruitment Status : Completed
First Posted : June 8, 2017
Results First Posted : March 22, 2023
Last Update Posted : March 22, 2023
While deep brain stimulation of the subthalamic nucleus (STN-DBS) is commonly used to reduce tremor, muscle stiffness, and bradykinesia in people with Parkinson disease (PD), preliminary studies suggest balance may worsen and falls may increase after STN-DBS. Walking speed, known to be reduced in PD, typically improves after surgery; however, other important gait qualities may not improve. Given the potential for worsening balance and gait and increasing falls after surgery, it is imperative that researchers explore interventions that complement the positive effects of STN-DBS and delay worsening of balance and gait.
Physical therapy (PT) is reported to be effective in improving balance and walking in people with PD. However, there have been no studies to investigate how individuals with STN-DBS respond to PT. As such, it is unclear if exercise in the post-DBS population is safe, feasible, and effective. The purpose of this study is to examine the safety, feasibility, and efficacy of PT in people with PD with STN-DBS.
The investigators hypothesize that PT will be safe and feasible for people with PD with STN-DBS. Further, the investigators hypothesize that those assigned to PT group will demonstrate improvements in balance and gait while those assigned to the control group will demonstrate no change or a decline in balance and gait.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Behavioral: Physical Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes assessor will be blinded to group assignment.|
|Official Title:||Physical Therapy and Deep Brain Stimulation in Parkinson Disease|
|Actual Study Start Date :||August 3, 2017|
|Actual Primary Completion Date :||August 2, 2019|
|Actual Study Completion Date :||August 2, 2019|
Experimental: Physical Therapy
Participants assigned to Physical Therapy (PT) will attend a 1-hour visit with a physical therapist twice weekly for 8 weeks. The PT intervention, which will mirror traditional PT for those with PD, will include exercises designed to improve balance and gait.
Behavioral: Physical Therapy
Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
Other Name: Physical Rehabilitation
No Intervention: Control
Participants in the control group will receive the current standard of care following STN-DBS. As such, STN-DBS settings and anti-PD medications will be optimized according to the determination of their neurologist in the same fashion as they will be in the experimental group. Those in the control group will not receive prescribed exercise from a physical therapist.
- Number of Participants With Treatment-Emergent Adverse Events [Safety & Tolerability] [ Time Frame: 8 weeks ]Number of participants with falls, orthopedic injuries, or other adverse events that are related to treatment.
- Treatment-Related Adherence [Feasibility] [ Time Frame: 8 weeks ]Feasibility of the treatment as measured by the number of PT sessions attended.
- Balance [ Time Frame: 8 weeks ]
Change in Balance Evaluation Systems Test score. The scale is scored from 0-100% with higher scores indicating better balance. Here, the higher the change score, the greater the improvement in balance.
A change score of 0.04 would correspond to a 4% improvement in the BESTest score. A change score of -0.02 would correspond to a 2% decline in BESTest score.
- Gait [ Time Frame: 8 weeks ]Change in gait velocity (cm/sec). Higher gait speeds are associated with better mobility. The greater the value for the change in gait speed, the greater the improvement in gait speed. Negative values would indicate a decline in gait speed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181282
|United States, Missouri|
|Washington University in St. Louis School of Medicine - Program in Physical Therapy|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Ryan P Duncan, DPT||Washington University in St. Louis School of Medicine - Program in Physical Therapy|