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Physical Therapy and Deep Brain Stimulation in Parkinson Disease (PTDBS)

This study is currently recruiting participants.
Verified October 2017 by Ryan Duncan, Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03181282
First Posted: June 8, 2017
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Ryan Duncan, Washington University School of Medicine
  Purpose

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 Intervention
Parkinson Disease Behavioral: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Outcomes assessor will be blinded to group assignment.
Primary Purpose: Treatment
Official Title: Physical Therapy and Deep Brain Stimulation in Parkinson Disease

Resource links provided by NLM:


Further study details as provided by Ryan Duncan, Washington University School of Medicine:

Primary Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events [Safety & Tolerability] [ Time Frame: 8 weeks ]
    Number of falls, orthopedic injuries, or other adverse events that are related to treatment.


Secondary Outcome Measures:
  • Treatment-Related Adherence [Feasibility] [ Time Frame: 8 weeks ]
    Feasibility of the treatment as measured by the percentage of PT sessions attended

  • Balance [ Time Frame: 8 weeks ]
    Change in Balance Evaluation Systems Test score

  • Gait [ Time Frame: 8 weeks ]
    Change in gait velocity (cm/sec)


Estimated Enrollment: 34
Actual Study Start Date: August 3, 2017
Estimated Study Completion Date: January 31, 2019
Estimated Primary Completion Date: January 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Ryan P Duncan, DPT 314-273-1052 duncanr@wustl.edu

Locations
United States, Missouri
Washington University in St. Louis School of Medicine - Program in Physical Therapy Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Ryan p Duncan, DPT    314-273-1052    duncanr@wustl.edu   
Principal Investigator: Ryan P Duncan, DPT         
Sponsors and Collaborators
Washington University School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Ryan P Duncan, DPT Washington University in St. Louis School of Medicine - Program in Physical Therapy
  More Information

Responsible Party: Ryan Duncan, Assistant Professor of Physical Therapy, Assistant Professor of Neurology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03181282     History of Changes
Other Study ID Numbers: 201609148
K12HD055931 ( U.S. NIH Grant/Contract )
First Submitted: June 5, 2017
First Posted: June 8, 2017
Last Update Posted: November 2, 2017
Last Verified: October 2017
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 Ryan Duncan, Washington University School of Medicine:
Deep brain stimulation
Balance
Gait
Physical Therapy
Parkinson disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases