Study Summary
This trial is testing whether adding physical therapy to standard deep brain stimulation surgery helps improve mobility for people with Parkinson’s disease, beyond what surgery alone can achieve.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: Visit 1: Baseline assessment at month 0, Visit 2: Pre-intervention assessment at month 3, Visit 4: Post-intervention assessment at month 6, and Visit 5: End of study assessment at month 8
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control group
1 of 2
Physiotherapy group
1 of 2
Active Control
Experimental Treatment
60 Total Participants · 2 Treatment Groups
Primary Treatment: Physiotherapy · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
How old are they?
18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
Met criteria | 100.0% |
- Rochester, Lynn, Sebastien Francois Martin Chastin, Sue Lord, Katherine Baker, and David John Burn. 2011. “Understanding the Impact of Deep Brain Stimulation on Ambulatory Activity in Advanced Parkinson’s Disease”. Journal of Neurology. Springer Science and Business Media LLC. doi:10.1007/s00415-011-6301-9.
- Leddy, Abigail L., Beth E. Crowner, and Gammon M. Earhart. 2011. “Utility of the Mini-bestest, Bestest, and Bestest Sections for Balance Assessments in Individuals with Parkinson Disease”. Journal of Neurologic Physical Therapy. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/npt.0b013e31821a620c.
- Steffen, Teresa, and Megan Seney. 2008. “Test-retest Reliability and Minimal Detectable Change on Balance and Ambulation Tests, the 36-item Short-form Health Survey, and the Unified Parkinson Disease Rating Scale in People with Parkinsonism”. Physical Therapy. Oxford University Press (OUP). doi:10.2522/ptj.20070214.
- Kelly, Valerie E., Shawn M. Israel, Ali Samii, Jefferson C. Slimp, Robert Goodkin, and Anne Shumway-Cook. 2009. “Assessing the Effects of Subthalamic Nucleus Stimulation on Gait and Mobility in People with Parkinson Disease”. Disability and Rehabilitation. Informa UK Limited. doi:10.3109/09638280903374139.
- Allert, Niels, Binith Cheeran, Günther Deuschl, Michael T. Barbe, Ilona Csoti, Markus Ebke, Martin Glaser, et al.. 2018. “Postoperative Rehabilitation After Deep Brain Stimulation Surgery for Movement Disorders”. Clinical Neurophysiology. Elsevier BV. doi:10.1016/j.clinph.2017.12.035.
- Grobbelaar, Roné, Ranel Venter, and Karen Estelle Welman. 2017. “Backward Compared to Forward over Ground Gait Retraining Have Additional Benefits for Gait in Individuals with Mild to Moderate Parkinson’s Disease: A Randomized Controlled Trial”. Gait & Posture. Elsevier BV. doi:10.1016/j.gaitpost.2017.08.019.
- Baker, Patricia S., Eric V. Bodner, and Richard M. Allman. 2003. “Measuring Life-space Mobility in Community-dwelling Older Adults”. Journal of the American Geriatrics Society. Wiley. doi:10.1046/j.1532-5415.2003.51512.x.
- Stack, Emma, and Ann Ashburn. 1999. “Fall Events Described by People with Parkinson's Disease: Implications for Clinical Interviewing and the Research Agenda”. Physiotherapy Research International. Wiley. doi:10.1002/pri.165.
- Tudor-Locke, Catrine, Cora L Craig, Yukitoshi Aoyagi, Rhonda C Bell, Karen A Croteau, Ilse De Bourdeaudhuij, Ben Ewald, et al.. 2011. “How Many Steps/day Are Enough? for Older Adults and Special Populations”. International Journal of Behavioral Nutrition and Physical Activity. Springer Science and Business Media LLC. doi:10.1186/1479-5868-8-80.
- Smania, Nicola, Elisabetta Corato, Michele Tinazzi, Clementina Stanzani, Antonio Fiaschi, Paolo Girardi, and Marialuisa Gandolfi. 2010. “Effect of Balance Training on Postural Instability in Patients with Idiopathic Parkinson’s Disease”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968310376057.
- Zhu, Lynn, Christian Duval, Patrick Boissy, Manuel Montero-Odasso, Guangyong Zou, Mandar Jog, and Mark Speechley. 2020. “Comparing Gps-based Community Mobility Measures with Self-report Assessments in Older Adults with Parkinson’s Disease”. Edited by Anne Newman. The Journals of Gerontology: Series A. Oxford University Press (OUP). doi:10.1093/gerona/glaa012.
- Ferrazzoli, Davide, Paola Ortelli, Graziella Madeo, Nir Giladi, Giselle M. Petzinger, and Giuseppe Frazzitta. 2018. “Basal Ganglia and Beyond: The Interplay Between Motor and Cognitive Aspects in Parkinson’s Disease Rehabilitation”. Neuroscience & Biobehavioral Reviews. Elsevier BV. doi:10.1016/j.neubiorev.2018.05.007.
- Franchignoni, F, F Horak, M Godi, A Nardone, and A Giordano. 2010. “Using Psychometric Techniques to Improve the Balance Evaluation Systems Test: The Mini-bestest”. Journal of Rehabilitation Medicine. Medical Journals Sweden AB. doi:10.2340/16501977-0537.
- Fasano, Alfonso, Camila C. Aquino, Joachim K. Krauss, Christopher R. Honey, and Bastiaan R. Bloem. 2015. “Axial Disability and Deep Brain Stimulation in Patients with Parkinson Disease”. Nature Reviews Neurology. Springer Science and Business Media LLC. doi:10.1038/nrneurol.2014.252.
- Shen, Xia, and Margaret K. Y. Mak. 2014. “Technology-assisted Balance and Gait Training Reduces Falls in Patients with Parkinson’s Disease”. Neurorehabilitation and Neural Repair. SAGE Publications. doi:10.1177/1545968314537559.
- Tinetti, Mary E., Mark Speechley, and Sandra F. Ginter. 1988. “Risk Factors for Falls Among Elderly Persons Living in the Community”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm198812293192604.
- Pradhan, Sujata, and Valerie E. Kelly. 2019. “Quantifying Physical Activity in Early Parkinson Disease Using a Commercial Activity Monitor”. Parkinsonism & Related Disorders. Elsevier BV. doi:10.1016/j.parkreldis.2019.08.001.
- Shen, X, and M Mak. 2012. “Repetitive Step Training with Preparatory Signals Improves Stability Limits in Patients with Parkinson’s Disease”. Journal of Rehabilitation Medicine. Medical Journals Sweden AB. doi:10.2340/16501977-1056.
- Gazibara, Tatjana, Darija Kisic Tepavcevic, Marina Svetel, Aleksandra Tomic, Iva Stankovic, Vladimir S. Kostic, and Tatjana Pekmezovic. 2017. “Near-falls in People with Parkinson's Disease: Circumstances, Contributing Factors and Association with Falling”. Clinical Neurology and Neurosurgery. Elsevier BV. doi:10.1016/j.clineuro.2017.08.008.
- HAMILTON, MAX. 1959. “The Assessment of Anxiety States by Rating”. British Journal of Medical Psychology. Wiley. doi:10.1111/j.2044-8341.1959.tb00467.x.
- Lozano, Andres M, Jonathan Dostrovsky, Robert Chen, and Peter Ashby. 2002. “Deep Brain Stimulation for Parkinson's Disease: Disrupting the Disruption”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(02)00101-1.
- Yamada, K., S. Goto, T. Hamasaki, and J.-I. Kuratsu. 2008. “Effect of Bilateral Subthalamic Nucleus Stimulation on Levodopa-unresponsive Axial Symptoms in Parkinson’s Disease”. Acta Neurochirurgica. Springer Science and Business Media LLC. doi:10.1007/s00701-007-1451-3.
- Tomlinson CL, Patel S, Meek C, Herd CP, Clarke CE, Stowe R, Shah L, Sackley CM, Deane KH, Wheatley K, Ives N. Physiotherapy versus placebo or no intervention in Parkinson's disease. Cochrane Database Syst Rev. 2013 Sep 10;(9):CD002817. doi: 10.1002/14651858.CD002817.pub4. Review.
- Nelson, Audrey, Gail Powell-Cope, Deborah Gavin-Dreschnack, Pat Quigley, Tatjana Bulat, Andrea S. Baptiste, Shawn Applegarth, and Yvonne Friedman. 2004. “Technology to Promote Safe Mobility in the Elderly”. Nursing Clinics of North America. Elsevier BV. doi:10.1016/j.cnur.2004.05.001.
- Pohl, Petra, Ellinor Nordin, Anders Lundquist, Ulrica Bergström, and Lillemor Lundin-Olsson. 2014. “Community-dwelling Older People with an Injurious Fall Are Likely to Sustain New Injurious Falls Within 5 Years - a Prospective Long-term Follow-up Study”. BMC Geriatrics. Springer Science and Business Media LLC. doi:10.1186/1471-2318-14-120.
- Nocera, Joe R., Elizabeth L. Stegemöller, Irene A. Malaty, Michael S. Okun, Michael Marsiske, and Chris J. Hass. 2013. “Using the Timed up & Go Test in a Clinical Setting to Predict Falling in Parkinson's Disease”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2013.02.020.
- Peto, V., C. Jenkinson, R. Fitzpatrick, and R. Greenhall. 1995. “The Development and Validation of a Short Measure of Functioning and Well Being for Individuals with Parkinson's Disease”. Quality of Life Research. Springer Science and Business Media LLC. doi:10.1007/bf02260863.
- Daneault, Jean-François, Christian Duval, Sébastien Barbat-Artigas, Mylène Aubertin-Leheudre, Nicolas Jodoin, Michel Panisset, and Abbas F. Sadikot. 2014. “Subthalamic Stimulation Improves Motor Function but Not Home and Neighborhood Mobility”. Movement Disorders. Wiley. doi:10.1002/mds.25911.
- Tomlinson, C. L., S. Patel, C. Meek, C. P. Herd, C. E. Clarke, R. Stowe, L. Shah, et al.. 2012. “Physiotherapy Intervention in Parkinson's Disease: Systematic Review and Meta-analysis”. Bmj. BMJ. doi:10.1136/bmj.e5004.
- Lindholm, Beata, Peter Hagell, Oskar Hansson, and Maria H. Nilsson. 2015. “Prediction of Falls And/or Near Falls in People with Mild Parkinson’s Disease”. Edited by Mathias Toft. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0117018.
- BECK, A. T.. 1961. “An Inventory for Measuring Depression”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archpsyc.1961.01710120031004.
- Lamont, Robyn M., Hannah L. Daniel, Caitlyn L. Payne, and Sandra G. Brauer. 2018. “Accuracy of Wearable Physical Activity Trackers in People with Parkinson’s Disease”. Gait & Posture. Elsevier BV. doi:10.1016/j.gaitpost.2018.04.034.
- Leddy, Abigail L., Beth E. Crowner, and Gammon M. Earhart. 2011. “Utility of the Mini-bestest, Bestest, and Bestest Sections for Balance Assessments in Individuals with Parkinson Disease”. Journal of Neurologic Physical Therapy. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/npt.0b013e31821a620c.
- Tomlinson CL, Patel S, Meek C, Herd CP, Clarke CE, Stowe R, Shah L, Sackley C, Deane KH, Wheatley K, Ives N. Physiotherapy intervention in Parkinson's disease: systematic review and meta-analysis. BMJ. 2012 Aug 6;345:e5004. doi: 10.1136/bmj.e5004.
- Nocera JR, Stegemoller EL, Malaty IA, Okun MS, Marsiske M, Hass CJ; National Parkinson Foundation Quality Improvement Initiative Investigators. Using the Timed Up & Go test in a clinical setting to predict falling in Parkinson's disease. Arch Phys Med Rehabil. 2013 Jul;94(7):1300-5. doi: 10.1016/j.apmr.2013.02.020. Epub 2013 Mar 6.
- Lozano AM, Dostrovsky J, Chen R, Ashby P. Deep brain stimulation for Parkinson's disease: disrupting the disruption. Lancet Neurol. 2002 Aug;1(4):225-31. doi: 10.1016/s1474-4422(02)00101-1.
- Allert N, Cheeran B, Deuschl G, Barbe MT, Csoti I, Ebke M, Glaser M, Kang JS, Kelm S, Krack P, Kroth J, Jobst U, Leisse M, Oliviero A, Nolte PN, Quick-Weller J, Strothjohann M, Tamas G, Werner M, Muthuraman M, Volkmann J, Fasano A, Groppa S. Postoperative rehabilitation after deep brain stimulation surgery for movement disorders. Clin Neurophysiol. 2018 Mar;129(3):592-601. doi: 10.1016/j.clinph.2017.12.035. Epub 2018 Jan 10.
- Fasano A, Aquino CC, Krauss JK, Honey CR, Bloem BR. Axial disability and deep brain stimulation in patients with Parkinson disease. Nat Rev Neurol. 2015 Feb;11(2):98-110. doi: 10.1038/nrneurol.2014.252. Epub 2015 Jan 13.
- Pohl P, Nordin E, Lundquist A, Bergstrom U, Lundin-Olsson L. Community-dwelling older people with an injurious fall are likely to sustain new injurious falls within 5 years--a prospective long-term follow-up study. BMC Geriatr. 2014 Nov 18;14:120. doi: 10.1186/1471-2318-14-120.
- Ferrazzoli D, Ortelli P, Madeo G, Giladi N, Petzinger GM, Frazzitta G. Basal ganglia and beyond: The interplay between motor and cognitive aspects in Parkinson's disease rehabilitation. Neurosci Biobehav Rev. 2018 Jul;90:294-308. doi: 10.1016/j.neubiorev.2018.05.007. Epub 2018 May 4.
- Stack E, Ashburn A. Fall events described by people with Parkinson's disease: implications for clinical interviewing and the research agenda. Physiother Res Int. 1999;4(3):190-200. doi: 10.1002/pri.165.
- Baker PS, Bodner EV, Allman RM. Measuring life-space mobility in community-dwelling older adults. J Am Geriatr Soc. 2003 Nov;51(11):1610-4. doi: 10.1046/j.1532-5415.2003.51512.x.
- Tinetti ME, Speechley M, Ginter SF. Risk factors for falls among elderly persons living in the community. N Engl J Med. 1988 Dec 29;319(26):1701-7. doi: 10.1056/NEJM198812293192604.
- Tudor-Locke C, Craig CL, Aoyagi Y, Bell RC, Croteau KA, De Bourdeaudhuij I, Ewald B, Gardner AW, Hatano Y, Lutes LD, Matsudo SM, Ramirez-Marrero FA, Rogers LQ, Rowe DA, Schmidt MD, Tully MA, Blair SN. How many steps/day are enough? For older adults and special populations. Int J Behav Nutr Phys Act. 2011 Jul 28;8:80. doi: 10.1186/1479-5868-8-80.
- Tomlinson CL, Patel S, Meek C, Herd CP, Clarke CE, Stowe R, Shah L, Sackley CM, Deane KH, Wheatley K, Ives N. Physiotherapy versus placebo or no intervention in Parkinson's disease. Cochrane Database Syst Rev. 2013 Sep 10;2013(9):CD002817. doi: 10.1002/14651858.CD002817.pub4.
- HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
- Steffen T, Seney M. Test-retest reliability and minimal detectable change on balance and ambulation tests, the 36-item short-form health survey, and the unified Parkinson disease rating scale in people with parkinsonism. Phys Ther. 2008 Jun;88(6):733-46. doi: 10.2522/ptj.20070214. Epub 2008 Mar 20. Erratum In: Phys Ther. 2010 Mar;90(3):462.
- BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Peto V, Jenkinson C, Fitzpatrick R, Greenhall R. The development and validation of a short measure of functioning and well being for individuals with Parkinson's disease. Qual Life Res. 1995 Jun;4(3):241-8. doi: 10.1007/BF02260863.
- Alfonso Fasano 2021. "Physiotherapy and Deep Brain Stimulation in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04953637.
Frequently Asked Questions
How many participants are currently involved in this research?
"Affirmative. According to clinicaltrials.gov, this experiment is presently searching for volunteers and was first announced on April 15th 2021 with the last edit being October 31st 2022. The trial needs 60 individuals from one clinic site." - Anonymous Online Contributor
Is recruitment of participants currently in progress for this experiment?
"Affirmative. Clinicaltrials.gov supports the notion that this research project, which commenced on April 15th 2021, is actively seeking volunteers. 60 participants need to be enrolled in 1 medical facility." - Anonymous Online Contributor