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N/A N=29 Randomized Single-blind Treatment

Physical Therapy and Deep Brain Stimulation in Parkinson Disease

Parkinson Disease

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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