Parkinson DiseaseNCT05180747
BUrst vs. Spaced Physical Therapy for Parkinson's Disease: The BUS PT Timing Trial
A study testing Frequency of physical therapy sessions in people with Parkinson Disease, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Frequency of physical therapy sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
About this study
Official title: A Randomized Trial of BUrst vs. Spaced Physical Therapy for Parkinson's Disease: The BUS PT Trial
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).
Read the detailed description
Parkinson's Disease (PD) is a progressive neurodegenerative disorder with a negative impact on quality of life.1 Many patients with PD will encounter difficulties with balance, posture, transfer, gait and physical capacity due to the motor symptoms of the disease.2 For these symptoms, physical therapy (PT) has been shown to be beneficial and clinically useful for the motor symptoms and thus is routinely prescribed alongside medical management. However, despite increasing evidence of the positive effects of physical therapy for patients with PD, there is no standard approach for organizing physiotherapy in the context of multidisciplinary care. Administration of physical therapy as a "burst" of frequent sessions delivered over 4-6 weeks is the most commonly employed strategy in PD patients and is driven largely by the payer system. Burst therapy has been useful in post-stroke and post traumatic brain injury rehabilitation, however, the investigators of this study hypothesize that this approach will be suboptimal in PD when compared to therapy which is "spaced" over a longer period of time. The purpose of this study is to randomize patients between typical "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).
30 PD patients were recruited as part of a pilot trial to assess the effectiveness of burst vs. spaced physical therapy (the BUS PT trial). Baseline measures were collected on all patients, including the timed up and go test (TUG), the baseline frequency of utilization of PT, falls, fractures, hospitalizations, the 10 meter walk test (10MWT), the Mini Balance Evaluation Systems Test (miniBESTest), objective gait analysis using Gaitrite, the Parkinson's Disease Questionnaire-39 (PDQ39), the Unified Parkinson's Disease Rating Scale (UPDRS) "ON" and "OFF" motor scores, the quantitation of the levodopa equivalent daily doses (LEDD), and the Godin Leisure Activity Questionnaire to assess baseline exercise levels.
The investigators hypothesized that "spaced" PT is beneficial for maintenance of physical function in PD. Prior collective evidence suggests that long-term continuous exercise in PD patients is associated with positive outcomes, however a spaced PT approach has not been employed. This study will provide useful data that will directly impact payer systems, reimbursements and access to care for PD patients.
- Conditions
- Parkinson Disease
- Being tested
- Frequency of physical therapy sessions
- Keywords
- Parkinson's Disease, Physical Therapy, Time Up and Go, Spaced Physical Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency of physical therapy sessionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Burst group | Other | Patients received two physical therapy sessions weekly for 6 weeks. Receives: Other: Frequency of physical therapy sessions |
| Spaced Group | Other | Patients received one physical therapy sessions every 2 weeks for 6 months. Receives: Other: Frequency of physical therapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 6-month follow up
Secondary outcomes (11)
Unified Parkinson's Disease Rating Scale (UPDRS) motor score
Minimum value for UPDRS part III is 0 and maximum value is 27. High scores mean a worse outcome.
Measured: Baseline up to 6-month follow up
The Mini Balance Evaluation Systems Test (MiniBesTest)
The MiniBesTest assesses dynamic balance: anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. It is a 14-item test scored on a 3 level ordinal scale. Minimum score is 0 and maximum score is 32. High scores mean better outcome.
Measured: Baseline up to 6-month follow up
10 meter walk test (10MWT)
This a performance measure used to assess walking speed in meters per second over a short distant.
Measured: Baseline up to 6-month follow up
Non-motor symptoms PD questionnaire (NMS)
NMS is a screening questionnaire comprising 30 items. It was not designed as a quantitative scale, however, a total score for the questionnaire is calculated by summing all the positive ("yes") responses. Minimum score is 0 and maximum score is 30. High scores correlate to worse outcomes. PD patients have higher scores when compared to control patients.
Measured: Baseline up to 6-month follow up
Parkinson's Disease Questionnaire-39 (PDQ39)
PDQ39 is a 39-item self reported questionnaire that assesses PD-specific health related quality over the last month. It assesses the 8 quality of life dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Minimum score is 0 and maximum score is 156. High scores mean worse outcomes.
Measured: Baseline up to 6-month follow up
Levodopa equivalent daily doses (LEDD)
Conversion factor to generate a total Levodopa equivalent daily dose (LEDD), calculated as a sum of each parkinsonian medication. LEDD provides an artificial summary of the total daily medication a patient is receiving .
Measured: Baseline up to 6-month follow up
Baseline frequency of utilization of PT
Frequency of PT sessions patients were having before starting the study.
Measured: Baseline up to 6-month follow up
Objective gait analysis using Gaitrite
Patients walk on a 3m walking mat embedded with 256 sensors that are triggered when pressure is applied. The GAITRite system automates measuring temporal (timing) and spatial (distance) gait parameters (temporal/spatial) and 8 levels of relative pressure. Data are processed by a second compatible computer by using GaitMat software.
Measured: Baseline up to 6-month follow up
Falls diary
It consists in one way of recording fall frequency and the surrounding circumstances. Patients are encouraged to recall and identify the key circumstances surrounding falls.
Measured: Baseline up to 6-month follow up
Godin Leisure Activity Questionnaire
Patients have to disclose how many times on the average typical 7-Day period (a week) they do the following kinds of exercise for 15 or more minutes: STRENUOUS EXERCISE (HEART BEATS RAPIDLY) (e.g., running, jogging, hockey, football, soccer, squash, basketball, cross country skiing, judo, roller skating, vigorous swimming, vigorous long distance bicycling); MODERATE EXERCISE (NOT EXHAUSTING) (e.g., fast walking, baseball, tennis, easy bicycling, volleyball, badminton, easy swimming, alpine skiing, popular and folk dancing) and MILD/LIGHT EXERCISE (MINIMAL EFFORT) (e.g., yoga, archery, fishing from river bank, bowling, horseshoes, golf, snow-mobiling, easy walking). Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). Minimum score is 0. Maximum score is 119. High scores mean that the patient is more active. Patients can be classified as sedentary (<14), moderately active (14-23) and active (24 or more).
Measured: Baseline up to 6-month follow up
Change between 6-week 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.
Measured: 6-week follow up (burst group only) and 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start3 Aug 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ka Loong Kelvin Au, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180747
- Sponsor's protocol ID
- IRB201903188
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices), study protocol and statistical analysis plan will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be submitted up to 36 months following article publication. After 36 months, data will be available in our University's data warehouse, but without investigator support other than deposited metadata. Proposals should be directed to janinelobolopes@ufl.edu.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of BUrst vs. Spaced Physical Therapy for Parkinson's Disease: The BUS PT Trial
- ClinicalTrials.gov ID
- NCT05180747
- Acronym / sponsor ID
- IRB201903188
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Physical Therapy, Time Up and Go, Spaced Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Parkinson's Disease (PD) is a progressive neurodegenerative disorder with a negative impact on quality of life.1 Many patients with PD will encounter difficulties with balance, posture, transfer, gait and physical capacity due to the motor symptoms of the disease.2 For these symptoms, physical therapy (PT) has been shown to be beneficial and clinically useful for the motor symptoms and thus is routinely prescribed alongside medical management. However, despite increasing evidence of the positive effects of physical therapy for patients with PD, there is no standard approach for organizing physiotherapy in the context of multidisciplinary care. Administration of physical therapy as a "burst" of frequent sessions delivered over 4-6 weeks is the most commonly employed strategy in PD patients and is driven largely by the payer system. Burst therapy has been useful in post-stroke and post traumatic brain injury rehabilitation, however, the investigators of this study hypothesize that this approach will be suboptimal in PD when compared to therapy which is "spaced" over a longer period of time. The purpose of this study is to randomize patients between typical "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).
30 PD patients were recruited as part of a pilot trial to assess the effectiveness of burst vs. spaced physical therapy (the BUS PT trial). Baseline measures were collected on all patients, including the timed up and go test (TUG), the baseline frequency of utilization of PT, falls, fractures, hospitalizations, the 10 meter walk test (10MWT), the Mini Balance Evaluation Systems Test (miniBESTest), objective gait analysis using Gaitrite, the Parkinson's Disease Questionnaire-39 (PDQ39), the Unified Parkinson's Disease Rating Scale (UPDRS) "ON" and "OFF" motor scores, the quantitation of the levodopa equivalent daily doses (LEDD), and the Godin Leisure Activity Questionnaire to assess baseline exercise levels.
The investigators hypothesized that "spaced" PT is beneficial for maintenance of physical function in PD. Prior collective evidence suggests that long-term continuous exercise in PD patients is associated with positive outcomes, however a spaced PT approach has not been employed. This study will provide useful data that will directly impact payer systems, reimbursements and access to care for PD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burst group | Other | Other: Frequency of physical therapy sessionsPatients received two physical therapy sessions weekly for 6 weeks. |
| Spaced Group | Other | Other: Frequency of physical therapy sessionsPatients received one physical therapy sessions every 2 weeks for 6 months. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequency of physical therapy sessionsPhysical 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. | Other | Burst group, Spaced Group |
Primary outcome
Change between baseline and 6-month Timed Up and Go test (TUG)
Time frame: Baseline up to 6-month follow up
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.
11 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS) motor score
Time frame: Baseline up to 6-month follow up
The Mini Balance Evaluation Systems Test (MiniBesTest)
Time frame: Baseline up to 6-month follow up
10 meter walk test (10MWT)
Time frame: Baseline up to 6-month follow up
Non-motor symptoms PD questionnaire (NMS)
Time frame: Baseline up to 6-month follow up
Parkinson's Disease Questionnaire-39 (PDQ39)
Time frame: Baseline up to 6-month follow up
Levodopa equivalent daily doses (LEDD)
Time frame: Baseline up to 6-month follow up
Baseline frequency of utilization of PT
Time frame: Baseline up to 6-month follow up
Objective gait analysis using Gaitrite
Time frame: Baseline up to 6-month follow up
Falls diary
Time frame: Baseline up to 6-month follow up
Godin Leisure Activity Questionnaire
Time frame: Baseline up to 6-month follow up
Change between 6-week and 6-month Timed Up and Go test (TUG)
Time frame: 6-week follow up (burst group only) and 6-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices), study protocol and statistical analysis plan will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be submitted up to 36 months following article publication. After 36 months, data will be available in our University's data warehouse, but without investigator support other than deposited metadata. Proposals should be directed to janinelobolopes@ufl.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Loong Kelvin Au, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frequency of physical therapy sessions in people with Parkinson Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between baseline and 6-month Timed Up and Go test (TUG) (time frame: Baseline up to 6-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.