Physical Therapy and Deep Brain Stimulation in Parkinson Disease

NCT03181282 | Completed Results DMC

• 2 other identifiers: 201609148K12HD055931
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Deep brain stimulation; Balance; Gait; Physical Therapy; Parkinson disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events [Safety & Tolerability]

  Number of participants with falls, orthopedic injuries, or other adverse events that are related to treatment.

  8 weeks

Secondary Outcomes (3)

• Treatment-Related Adherence [Feasibility]

  8 weeks

• Balance

  8 weeks

• Gait

  8 weeks

Study Arms (2)

Physical Therapy

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Physical Therapy BEHAVIORAL

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.

Also known as: Physical Rehabilitation

Physical Therapy

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson disease
• Hoehn \& Yahr stages II-IV
• At least 1 year post-STN-DBS
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Washington University in St. Louis School of Medicine - Program in Physical Therapy

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

• Duncan RP, Van Dillen LR, Garbutt JM, Earhart GM, Perlmutter JS. Physical therapy and deep brain stimulation in Parkinson's Disease: protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2018 Feb 21;4:54. doi: 10.1186/s40814-018-0243-2. eCollection 2018.

  PMID: 29484198 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Limitations and Caveats

This was a small trial with a small number of participants. The intervention lasted only 8 weeks. Further, there were baseline differences between the groups that should be considered when interpreting the results.

Results Point of Contact

• Title: Ryan Duncan
• Organization: Washington University in St. Louis

duncanr@wustl.edu

314-273-1052

Study Officials

• Ryan P Duncan, DPT

  Washington University in St. Louis School of Medicine - Program in Physical Therapy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy, Assistant Professor of Neurology

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 8, 2017
• Study Start: August 3, 2017
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: March 22, 2023
• Results First Posted: March 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)