N/A
N=29
Physical Therapy and Deep Brain Stimulation in Parkinson Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03181282 ↗Enrolled (actual)
29
Serious AEs
10.3%
Results posted
Mar 2023
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events [Safety & Tolerability] — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Therapy (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events [Safety & Tolerability] |
1 | — |
| SECONDARY Treatment-Related Adherence [Feasibility] |
15 | — |
| SECONDARY Balance |
0.04; -0.02; 0.03; -0.04 | 0.0194 sig |
| SECONDARY Gait |
9.71; -1.07; 7.29; -1.00 | 0.038389 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of idiopathic Parkinson disease
- Hoehn & Yahr stages II-IV
- At least 1 year post-STN-DBS
- Able to provide informed consent
Exclusion Criteria
- Diagnosis of atypical parkinsonism
- Hoehn & Yahr stages I or V
- Evidence of dementia (MMSE < 24/30)
- Inability to walk 10 meters with or without assistive device
Data sourced from ClinicalTrials.gov (NCT03181282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.