BUrst vs. Spaced Physical Therapy for Parkinson's Disease: The BUS PT Timing Trial

NCT05180747 | Completed

• 1 other identifier: IRB201903188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients with Parkinson's Disease (PD) will encounter difficulties with balance, posture, and gait for which physical therapy (PT) has been shown to be beneficial. The purpose of this study is to randomize patients between standard "burst" PT versus "spaced" PT to inform on the optimal frequency of PT for PD patients. Burst PT in this study was defined as 2 PT visits per week for 6 weeks (12 sessions) and spaced PT, as 1 PT visit every other week for 6 months (12 sessions).

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Physical Therapy; Time Up and Go; Spaced Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Change between baseline and 6-month Timed Up and Go test (TUG)

  The TUG test is a validated and reliable tool to assess balance and mobility in Parkinson's disease. It has been used as an outcome measure in many trials involving PT and exercise in PD and is frequently included in standard PT visits. Patients wear their regular footwear and can use a walking aid, if needed. Patient starts the test sitting back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. Once examiner says go. the patient has to get up from the chair, walk until the line on the floor, come back and sit down on the chair. Timing begins when examiner says "go" and stops after patients sits back down. An older adult that takes 12 or more seconds to complete the task is at risk for falling.

  Baseline up to 6-month follow up

Secondary Outcomes (11)

• Unified Parkinson's Disease Rating Scale (UPDRS) motor score

  Baseline up to 6-month follow up

• The Mini Balance Evaluation Systems Test (MiniBesTest)

  Baseline up to 6-month follow up

• 10 meter walk test (10MWT)

  Baseline up to 6-month follow up

• Non-motor symptoms PD questionnaire (NMS)

  Baseline up to 6-month follow up

• Parkinson's Disease Questionnaire-39 (PDQ39)

  Baseline up to 6-month follow up

Study Arms (2)

Burst group

OTHER

Patients received two physical therapy sessions weekly for 6 weeks.

Other: Frequency of physical therapy sessions

Spaced Group

OTHER

Patients received one physical therapy sessions every 2 weeks for 6 months.

Other: Frequency of physical therapy sessions

Interventions

Frequency of physical therapy sessions OTHER

Physical therapy sessions consisted of standard of care practice at our center of excellence i two different frequencies. All patients in both groups received 12 physical therapy sessions. Patients in the burst group received 2 physical therapy sessions per week in 6 weeks, while patients in the spaced group received 1 session every 2 weeks for 6 months.

Burst group; Spaced Group

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-90 years
• Parkinson's disease as measured by Hoehn \& Yahr stage 2-3
• Idiopathic Parkinson's Disease patients diagnosed by a Movement Disorder Neurologist
• Stable dopaminergic medication for 1 month prior to the study and during the study (6 month intervention)
• Requires ongoing physical therapy as assessed by a physical therapist

You may not qualify if:

• Comorbidities including orthopedic injuries or cardiopulmonary disease that would potentially interfere with physical therapy and assessments
• Severe cognitive impairments (MMSE \<21)
• Unable to participate in all therapy sessions

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Ka Loong Kelvin Au, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded study. Participants were randomly assigned (1:1) to either burst or spaced groups using a computer random generated sequence. Group allocation could not be hidden from the study participant and thus once baseline measurements were recorded, a disclosure of assignment was made by the study PI. Patients Outcomes measures were be performed at baseline and 6 months by a blinded rater.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 6, 2022
• Study Start: August 3, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 36 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal

Locations

US (1)