Parkinson DiseaseNCT02302144
A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease
A study testing Balance & Strengthening Exercises in people with Parkinson Disease, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
The primary objective of this study is to investigate the effects of a theoretically driven, highly challenging exercise program (balance and strengthening exercises) in reducing fall rate, improving balance and reducing fear of falling in persons with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Balance & Strengthening Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a diagnosis of idiopathic Parkinson's disease (using UK Brain Bank Criteria)
- have a Hoehn \& Yahr stage of 2-4 during the "ON" state
- Mini mental status score > 26
- be 40 years of age or older, so as to represent the typical age range of PD
- be on a stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 3 month study period.
- have experienced at least one fall in the past 3 months and greater or equal to 2 falls in the past one-year (A fall was defined as an unexpected event where the person inadvertently came to rest on the ground or other lower level not due to a major intrinsic or extrinsic event)
Show all 10Show fewer
- able to walk without physical assistance or an assistive device for at least 5 continuous minutes
- able to understand, communicate with and be understood by recruitment personnel
- able to attend the exercise program twice per week at Sargent College
- be interested in participating and provide informed consent
Who cannot join
- have a diagnosis of atypical Parkinsonism
- have a Hoehn \& Yahr stage of 1 or 5
- have had previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
- serious co-morbidities that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))
- be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Neurorehabilitation, College of Health & Rehabilitation Sciences, Sargent College, Boston University
Boston, Massachusetts, 02215
About this study
The primary objective of this study is to investigate the effects of a theoretically driven, highly challenging exercise program (balance and strengthening exercises) in reducing fall rate, improving balance and reducing fear of falling in persons with Parkinson's disease.
In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be randomly assigned to either an early start (immediately following enrollment) or late start (3 months after enrollment) multifactorial exercise program which will meet 2 times per week for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening exercises which will be individualized depending on the ability of each participant. Fall rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be enrolled for 6-7 months.
- Conditions
- Parkinson Disease
- Being tested
- Balance & Strengthening Exercises
- Keywords
- Postural Instability (falling), Gait Disturbances (e.g., freezing), Bradykinesia (slowness of movement), rigidity
- Medical subject headings
- Parkinson Disease, Mobility Limitation, Hypokinesia, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance & Strengthening ExercisesBehavioural
Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual
| Study group | Role | What they receive |
|---|---|---|
| Early Multi-Ex-PD | Experimental | Immediately following enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests. Receives: Behavioral: Balance & Strengthening Exercises |
| Late Multi-Ex-PD | Experimental | Three months after enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests. Receives: Behavioral: Balance & Strengthening Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls Diary
Subjects will be asked to record each falling episode in the falls diary at the time of the fall or as soon as possible in relation to the actual time that the fall occurred. Subjects will be interviewed regarding fall episodes at each treatment session.
Measured: 6-7 Months
Secondary outcomes (15)
Change in Activities-specific Balance Confidence
Activities-specific Balance Confidence (ABC) Scale is a self-administered questionnaire in which subjects rate their level of confidence in performing a series of 16 activities.
Measured: 6-7 Months
Change in Falls Self-Efficacy
The Falls Self-Efficacy Scale is a self-administered questionnaire in which subjects rate their level of concern about falling when performing designated activities.
Measured: 6-7 Months
Change in Balance Evaluation Systems Test (BESTest)
The Balance Evaluation Systems Test (BESTest) is a 36 item test which is used to assess postural control / balance. Subjects are asked to perform a series of tasks such as sitting and leaning, standing on compliant and noncompliant surfaces, stepping forward, backward and to the side and walking on level and unlevel surfaces, while turning the head and while negotiating obstacles.
Measured: 6-7 Months
Change in Six-Minute Walk Test
The six-minute walk test (6MWT) is a measure of the distance a participant walks in a 6 minute time period. The 6-minute walk test is a safe, simple and useful measure of walking ability in patients with Parkinson's disease. The test will be carried out on level, obstacle-free enclosed corridors.
Measured: 6-7 Months
Change in Freezing of Gait Questionnaire
The Freezing of Gait Questionnaire (FOG) is a 6-item test in which the patient is interviewed and asked questions about their walking ability.
Measured: 6-7 Months
Change in Unified Parkinson's Disease Rating Scale
Section I, II, III and IV of the Unified Parkinson's Disease Rating Scale (UPDRS) will be utilized to assess nonmotor and motor signs.
Measured: 6-7 Months
Change in Scales for Outcomes in Parkinson Disease
The Scales for Outcomes in Parkinson Disease (SCOPA-AUT) consists of 26 items assessing autonomic function including gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillomotor and sexual function.
Measured: 6-7 Months
Change in Parkinson's Disease Questionnaire-39
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a quality of life instrument that contains 39-self-report items and was specifically developed for people with Parkinson's disease. The PDQ-39 measures the degree of healthy, competent, and satisfying participation in daily life activities.
Measured: 6-7 Months
Change in Beck Anxiety Inventory
The Beck Anxiety Inventory (BAI) is a measure of the severity of anxiety in adolescents and adults. The items assess typical features of anxiety, and the measure.
Measured: 6-7 Months
Changes in Beck Depression Inventory Second Edition
The Beck Depression Inventory Second Edition (BDI-II) is a measure of the severity of depression in adolescents and adults. The items target common symptoms of depression.
Measured: 6-7 Months
Changes in Penn State Worry Questionnaire
The Penn State Worry Questionnaire (PSWQ) is a measure of the worry characteristic of generalized anxiety disorder (GAD). Specifically, this measure of pathological worry assesses three areas of worry (generality, excessiveness, and uncontrollability).
Measured: 6-7 Months
Change in Panic Disorder Severity Scale
The Panic Disorder Severity Scale (PDSS) is a questionnaire designed to measure the overall severity of panic disorder. The items assess the severity of seven dimensions of panic disorder and associated symptoms: frequency of panic attacks, distress during panic attacks, panic-focused anticipatory anxiety, phobic avoidance of situations, phobic avoidance of physical sensations, and impairment and interference in work and social functioning.
Measured: 6-7 Months
Changes in Anxiety Sensitivity Index
The Anxiety Sensitivity Index (ASI) is an instrument on which respondents rate the degree to which they fear negative consequences resulting from anxiety symptoms. It yields a total score, representing the global-order anxiety sensitivity factor, as well as three lower-order factor scores, representing physical, psychological, and social concerns.
Measured: 6-7 Months
Changes in Social Phobia Inventor
The Social Phobia Inventory (SPIN) is a self-report questionnaire used to measure symptoms of social phobia (or social anxiety disorder). The SPIN specifically evaluates the spectrum of fear (e.g. fear of being embarrassed), avoidance (e.g. avoidance of parties), and physiological (e.g. blushing) symptoms associated with social phobia.
Measured: 6-7 Months
Changes in Social Interaction Anxiety Scale
The Social Interaction Anxiety Scale (SIAS) is a self-report questionnaire used to measure general fears of social interaction and fears of being scrutinized during activities and performance tasks. The scale is intended to measure affective, behavioral, and cognitive reactions in 20 social interaction situations.
Measured: 6-7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry Ellis, PhD, PT, NCS, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302144
- Sponsor's protocol ID
- BU-SAR-BAL
- Status last verified
- Jul 2017
- First submitted
- 24 Nov 2014
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2.
PubMed 19370674Wood BH, Bilclough JA, Bowron A, Walker RW. Incidence and prediction of falls in Parkinson's disease: a prospective multidisciplinary study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):721-5. doi: 10.1136/jnnp.72.6.721.
PubMed 12023412Genever RW, Downes TW, Medcalf P. Fracture rates in Parkinson's disease compared with age- and gender-matched controls: a retrospective cohort study. Age Ageing. 2005 Jan;34(1):21-4. doi: 10.1093/ageing/afh203.
PubMed 15591480Melton LJ 3rd, Leibson CL, Achenbach SJ, Bower JH, Maraganore DM, Oberg AL, Rocca WA. Fracture risk after the diagnosis of Parkinson's disease: Influence of concomitant dementia. Mov Disord. 2006 Sep;21(9):1361-7. doi: 10.1002/mds.20946.
PubMed 16703587Johnell O, Melton LJ 3rd, Atkinson EJ, O'Fallon WM, Kurland LT. Fracture risk in patients with parkinsonism: a population-based study in Olmsted County, Minnesota. Age Ageing. 1992 Jan;21(1):32-8. doi: 10.1093/ageing/21.1.32.
PubMed 1553857Temlett JA, Thompson PD. Reasons for admission to hospital for Parkinson's disease. Intern Med J. 2006 Aug;36(8):524-6. doi: 10.1111/j.1445-5994.2006.01123.x.
PubMed 16866658Hely MA, Morris JG, Traficante R, Reid WG, O'Sullivan DJ, Williamson PM. The sydney multicentre study of Parkinson's disease: progression and mortality at 10 years. J Neurol Neurosurg Psychiatry. 1999 Sep;67(3):300-7. doi: 10.1136/jnnp.67.3.300.
PubMed 10449550Spottke AE, Reuter M, Machat O, Bornschein B, von Campenhausen S, Berger K, Koehne-Volland R, Rieke J, Simonow A, Brandstaedter D, Siebert U, Oertel WH, Ulm G, Dodel R. Cost of illness and its predictors for Parkinson's disease in Germany. Pharmacoeconomics. 2005;23(8):817-36. doi: 10.2165/00019053-200523080-00007.
PubMed 16097843Jacobs JV, Horak FB. Cortical control of postural responses. J Neural Transm (Vienna). 2007;114(10):1339-48. doi: 10.1007/s00702-007-0657-0. Epub 2007 Mar 29.
PubMed 17393068Bloem BR, Beckley DJ, van Dijk JG, Zwinderman AH, Remler MP, Roos RA. Influence of dopaminergic medication on automatic postural responses and balance impairment in Parkinson's disease. Mov Disord. 1996 Sep;11(5):509-21. doi: 10.1002/mds.870110506.
PubMed 8866492Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. doi: 10.1136/bmj.328.7441.680.
PubMed 15031239Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. doi: 10.1056/NEJM199409293311301.
PubMed 8078528Rose DJ. Preventing falls among older adults: no "one size suits all" intervention strategy. J Rehabil Res Dev. 2008;45(8):1153-66.
PubMed 19235117Ashburn A, Fazakarley L, Ballinger C, Pickering R, McLellan LD, Fitton C. A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):678-84. doi: 10.1136/jnnp.2006.099333. Epub 2006 Nov 21.
PubMed 17119004Pickering RM, Grimbergen YA, Rigney U, Ashburn A, Mazibrada G, Wood B, Gray P, Kerr G, Bloem BR. A meta-analysis of six prospective studies of falling in Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1892-900. doi: 10.1002/mds.21598.
PubMed 17588236
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT02302144
- Acronym / sponsor ID
- BU-SAR-BAL
- Conditions
- Parkinson Disease
- Keywords
- Postural Instability (falling), Gait Disturbances (e.g., freezing), Bradykinesia (slowness of movement), rigidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Nov 2014 (estimated)
- 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.
The primary objective of this study is to investigate the effects of a theoretically driven, highly challenging exercise program (balance and strengthening exercises) in reducing fall rate, improving balance and reducing fear of falling in persons with Parkinson's disease.
In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be randomly assigned to either an early start (immediately following enrollment) or late start (3 months after enrollment) multifactorial exercise program which will meet 2 times per week for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening exercises which will be individualized depending on the ability of each participant. Fall rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be enrolled for 6-7 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Multi-Ex-PD | Experimental | Behavioral: Balance & Strengthening ExercisesImmediately following enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests. |
| Late Multi-Ex-PD | Experimental | Behavioral: Balance & Strengthening ExercisesThree months after enrollment, subjects will participate in a group balance and strengthening program (Multi-Ex-PD) 2x/week for 90 minutes over 3 months within the Center for Neurorehabilitation at Sargent College. Each of the exercises consists of a progression which ranges from less challenging to more challenging. The program will be individualized to the subject to appropriately match their abilities. Each subject will be progressed to a more challenging exercise once specific criteria are met. Resistance for the strengthening exercises will be applied using weighted vests. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- have a diagnosis of idiopathic Parkinson's disease (using UK Brain Bank Criteria)
- have a Hoehn \& Yahr stage of 2-4 during the "ON" state
- Mini mental status score > 26
- be 40 years of age or older, so as to represent the typical age range of PD
- be on a stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 3 month study period.
Key exclusion criteria (5 listed)
- have a diagnosis of atypical Parkinsonism
- have a Hoehn \& Yahr stage of 1 or 5
- have had previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
- serious co-morbidities that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))
- be pregnant
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 |
|---|---|---|
| Balance & Strengthening ExercisesProgressive balance and strengthening exercises conducted in a group format yet tailored to each individual | Behavioural | Early Multi-Ex-PD, Late Multi-Ex-PD |
Primary outcome
Falls Diary
Time frame: 6-7 Months
Subjects will be asked to record each falling episode in the falls diary at the time of the fall or as soon as possible in relation to the actual time that the fall occurred. Subjects will be interviewed regarding fall episodes at each treatment session.
15 secondary outcomes
Change in Activities-specific Balance Confidence
Time frame: 6-7 Months
Change in Falls Self-Efficacy
Time frame: 6-7 Months
Change in Balance Evaluation Systems Test (BESTest)
Time frame: 6-7 Months
Change in Six-Minute Walk Test
Time frame: 6-7 Months
Change in Freezing of Gait Questionnaire
Time frame: 6-7 Months
Change in Unified Parkinson's Disease Rating Scale
Time frame: 6-7 Months
Change in Scales for Outcomes in Parkinson Disease
Time frame: 6-7 Months
Change in Parkinson's Disease Questionnaire-39
Time frame: 6-7 Months
Change in Beck Anxiety Inventory
Time frame: 6-7 Months
Changes in Beck Depression Inventory Second Edition
Time frame: 6-7 Months
Changes in Penn State Worry Questionnaire
Time frame: 6-7 Months
Change in Panic Disorder Severity Scale
Time frame: 6-7 Months
Changes in Anxiety Sensitivity Index
Time frame: 6-7 Months
Changes in Social Phobia Inventor
Time frame: 6-7 Months
Changes in Social Interaction Anxiety Scale
Time frame: 6-7 Months
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 20 Jul 2026.
- Background: PubMed 19370674Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, Rowe BH. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007146. doi: 10.1002/14651858.CD007146.pub2.
- Background: PubMed 12023412Wood BH, Bilclough JA, Bowron A, Walker RW. Incidence and prediction of falls in Parkinson's disease: a prospective multidisciplinary study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):721-5. doi: 10.1136/jnnp.72.6.721.
- Background: PubMed 15591480Genever RW, Downes TW, Medcalf P. Fracture rates in Parkinson's disease compared with age- and gender-matched controls: a retrospective cohort study. Age Ageing. 2005 Jan;34(1):21-4. doi: 10.1093/ageing/afh203.
- Background: PubMed 16703587Melton LJ 3rd, Leibson CL, Achenbach SJ, Bower JH, Maraganore DM, Oberg AL, Rocca WA. Fracture risk after the diagnosis of Parkinson's disease: Influence of concomitant dementia. Mov Disord. 2006 Sep;21(9):1361-7. doi: 10.1002/mds.20946.
- Background: PubMed 1553857Johnell O, Melton LJ 3rd, Atkinson EJ, O'Fallon WM, Kurland LT. Fracture risk in patients with parkinsonism: a population-based study in Olmsted County, Minnesota. Age Ageing. 1992 Jan;21(1):32-8. doi: 10.1093/ageing/21.1.32.
- Background: PubMed 16866658Temlett JA, Thompson PD. Reasons for admission to hospital for Parkinson's disease. Intern Med J. 2006 Aug;36(8):524-6. doi: 10.1111/j.1445-5994.2006.01123.x.
- Background: PubMed 10449550Hely MA, Morris JG, Traficante R, Reid WG, O'Sullivan DJ, Williamson PM. The sydney multicentre study of Parkinson's disease: progression and mortality at 10 years. J Neurol Neurosurg Psychiatry. 1999 Sep;67(3):300-7. doi: 10.1136/jnnp.67.3.300.
- Background: PubMed 16097843Spottke AE, Reuter M, Machat O, Bornschein B, von Campenhausen S, Berger K, Koehne-Volland R, Rieke J, Simonow A, Brandstaedter D, Siebert U, Oertel WH, Ulm G, Dodel R. Cost of illness and its predictors for Parkinson's disease in Germany. Pharmacoeconomics. 2005;23(8):817-36. doi: 10.2165/00019053-200523080-00007.
- Background: PubMed 17393068Jacobs JV, Horak FB. Cortical control of postural responses. J Neural Transm (Vienna). 2007;114(10):1339-48. doi: 10.1007/s00702-007-0657-0. Epub 2007 Mar 29.
- Background: PubMed 8866492Bloem BR, Beckley DJ, van Dijk JG, Zwinderman AH, Remler MP, Roos RA. Influence of dopaminergic medication on automatic postural responses and balance impairment in Parkinson's disease. Mov Disord. 1996 Sep;11(5):509-21. doi: 10.1002/mds.870110506.
- Background: PubMed 15031239Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. doi: 10.1136/bmj.328.7441.680.
- Background: PubMed 8078528Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. doi: 10.1056/NEJM199409293311301.
- Center for Neurorehabilitation at Boston UniversityLink provided by the sponsor.
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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.
Terry Ellis, PhD, PT, NCS principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance & Strengthening Exercises in people with Parkinson Disease, run by Boston University Charles River Campus 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 10 inclusion and 5 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 20 Jul 2026. 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?
Falls Diary (time frame: 6-7 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302144, which also lists 24 linked publications.
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 20 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.