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
Month 6
Exploratory outcome - average number of steps
Exploratory outcome - distance
Exploratory outcome - heart rate
Exploratory outcome - physically active time
Exploratory outcome - sleep quality
Month 8
Number of falls and near falls
Month 8
Anxiety
Balance
Balance confidence
Exercise and activity levels
Falls risk and functional mobility
Gait
Health-related quality of life
Mood
Parkinson's disease symptoms
Month 8
Change in mobility measures
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
Physiotherapy group
Other
Experimental Group · 1 Intervention: Physiotherapy · Intervention Types: OtherControl groupNoIntervention Group · 1 Intervention: Control group · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Who is running the clinical trial?
University of TorontoLead Sponsor
640 Previous Clinical Trials
732,198 Total Patients Enrolled
Alfonso Fasano, MD, PhDPrincipal InvestigatorUniversity of Toronto
3 Previous Clinical Trials
68 Total Patients Enrolled
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% |
References
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- 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.
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- 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
Unverified Answer
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
Unverified Answer