Parkinson DiseaseNCT04877951
PC in Stance and During Functional Mobility Following BIG for PD
A study testing LSVT BIG in people with Parkinson Disease, run by University of South Dakota.
Trial summary
LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. We are interested in knowing the effects of this therapeutic approach on postural control and gait parameters. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LSVT BIG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects will be included in the study if they have been diagnosed with idiopathic Parkinson's disease and are English speaking.
Who cannot join
- Exclusion Criteria: 1) previous completion of LSVT BIG or other formal amplitude program training 2) non-idopathic Parkinsonism 3) any medical condition that would contraindicate exercise (ie. unstable cardiovascular disease) 4) cognitive impairment that limits ability to follow direction or demonstration
About this study
Official title: Postural Control in Stance and During Functional Mobility Following Management of Parkinson's Disease With LSVT BIG Training
LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. We are interested in knowing the effects of this therapeutic approach on postural control and gait parameters.
Read the detailed description
LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. Postural instability and gait disturbance is another debilitating feature of Parkinson's disease. While LSVT BIG targets postural correction through exercises which challenge balance, the effect of this intervention on stability margins and functional balance assessments have not been well established in the literature. This study includes outcome measures not previously examined with this intervention and may provide valuable evidence regarding the impact of this intervention on postural control, balance and falls risk. Alternative amplitude programs have also been designed to meet the needs of patients with PD. These programs adjust frequencies for patients and individualize sessions more than LSVT BIG. We are interested in knowing if these alternative frequencies and amplitude approaches are similarly as effective as LSVT BIG in our outcome measures.
- Conditions
- Parkinson Disease
- Being tested
- LSVT BIG
- Keywords
- postural control, gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSVT BIGBehavioural
LSVT BIG is a 4-week program that focuses on movement recalibration for people with a diagnosis of Parkinson's disease.
| Study group | Role | What they receive |
|---|---|---|
| Effect of LSVT BIG therapy on Postural Control and Gait Parameters | Other | LSVT BIG is a commonly used protocol to manage functional movement for those with Parkinson's Disease. This study measured postural control and gait parameters following a 4-week course of LSVT BIG therapy. Receives: Behavioral: LSVT BIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Balance Evaluation Systems Test (Mini-BESTest)
A change in reactive, proactive, and sensory contributions to postural control (balance) is assessed.
Measured: Pre-Intervention (baseline) and Post-Intervention (week 5)
Fullerton Advanced Balance Scale (FAB)
A change in higher level assessment of postural control is assessed.
Measured: Pre-Intervention (baseline) and Post-Intervention (week 5)
Functional and Multidirectional Reach Tests
A change in proactive postural control strategies is assessed.
Measured: Pre-Intervention (baseline) and Post-Intervention (week 5)
Center of Pressure measures (digitized walkway)
A change in the limits of stability is assessed.
Measured: Pre-Intervention (baseline) and Post-Intervention (week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study startMar 2015
- Primary completionJun 2016
- Study completionJan 2017
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Dakota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patti Berg-Poppe, University of South Dakota
- Investigators
- Patti J Berg-Poppe, PhD, Principal investigator, University of South Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877951
- Sponsor's protocol ID
- PC in PD after BIG
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Control in Stance and During Functional Mobility Following Management of Parkinson's Disease With LSVT BIG Training
- ClinicalTrials.gov ID
- NCT04877951
- Acronym / sponsor ID
- PC in PD after BIG
- Conditions
- Parkinson Disease
- Keywords
- postural control, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of South DakotaUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 May 2021 (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.
LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. We are interested in knowing the effects of this therapeutic approach on postural control and gait parameters.
Detailed description
LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. Postural instability and gait disturbance is another debilitating feature of Parkinson's disease. While LSVT BIG targets postural correction through exercises which challenge balance, the effect of this intervention on stability margins and functional balance assessments have not been well established in the literature. This study includes outcome measures not previously examined with this intervention and may provide valuable evidence regarding the impact of this intervention on postural control, balance and falls risk. Alternative amplitude programs have also been designed to meet the needs of patients with PD. These programs adjust frequencies for patients and individualize sessions more than LSVT BIG. We are interested in knowing if these alternative frequencies and amplitude approaches are similarly as effective as LSVT BIG in our outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of LSVT BIG therapy on Postural Control and Gait Parameters | Other | Behavioral: LSVT BIGLSVT BIG is a commonly used protocol to manage functional movement for those with Parkinson's Disease. This study measured postural control and gait parameters following a 4-week course of LSVT BIG therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will be included in the study if they have been diagnosed with idiopathic Parkinson's disease and are English speaking.
Key exclusion criteria (1 listed)
- Exclusion Criteria: 1) previous completion of LSVT BIG or other formal amplitude program training 2) non-idopathic Parkinsonism 3) any medical condition that would contraindicate exercise (ie. unstable cardiovascular disease) 4) cognitive impairment that limits ability to follow direction or demonstration
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 |
|---|---|---|
| LSVT BIGLSVT BIG is a 4-week program that focuses on movement recalibration for people with a diagnosis of Parkinson's disease. | Behavioural | Effect of LSVT BIG therapy on Postural Control and Gait Parameters |
Primary outcome
Mini Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Pre-Intervention (baseline) and Post-Intervention (week 5)
A change in reactive, proactive, and sensory contributions to postural control (balance) is assessed.
Fullerton Advanced Balance Scale (FAB)
Time frame: Pre-Intervention (baseline) and Post-Intervention (week 5)
A change in higher level assessment of postural control is assessed.
Functional and Multidirectional Reach Tests
Time frame: Pre-Intervention (baseline) and Post-Intervention (week 5)
A change in proactive postural control strategies is assessed.
Center of Pressure measures (digitized walkway)
Time frame: Pre-Intervention (baseline) and Post-Intervention (week 5)
A change in the limits of stability is assessed.
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 7 May 2021.
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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.
Patti J Berg-Poppe, PhD principal investigator
University of South Dakota
Questions about this trial
What is this clinical trial studying?
A study testing LSVT BIG in people with Parkinson Disease, run by University of South Dakota.
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 1 inclusion and 1 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 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Mini Balance Evaluation Systems Test (Mini-BESTest) (time frame: Pre-Intervention (baseline) and Post-Intervention (week 5)). The study lists 4 primary outcomes in all. 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 7 May 2021.