Balance Tele-Rehab in Parkinson's Disease Parkinson's Disease
NCT ID: NCT05680597
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2022-09-19
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Supervised Tele-Rehabilitation Home Exercise
40 participants will have tele-rehabilitation virtually with a physical therapist for 60 minutes approximately three times per week for four weeks of intervention (12 visits). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors.
Balance Tele-Rehabilitation Agility Boot Camp (ABC)
The intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes approximately three times a week for four weeks (12 sessions). Participants will be assessed for seven days pre and post intervention using wearable sensors (APDM wearable technologies) to monitor daily mobility.
Unsupervised Rehabilitation Home Exercise
40 participants will complete their home exercise Agility Boot Camp (ABC) program for 60 minutes approximately three times per week for four weeks of intervention (12 sessions). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors.
Balance Tele-Rehabilitation Agility Boot Camp (ABC)
The intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes approximately three times a week for four weeks (12 sessions). Participants will be assessed for seven days pre and post intervention using wearable sensors (APDM wearable technologies) to monitor daily mobility.
Interventions
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Balance Tele-Rehabilitation Agility Boot Camp (ABC)
The intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes approximately three times a week for four weeks (12 sessions). Participants will be assessed for seven days pre and post intervention using wearable sensors (APDM wearable technologies) to monitor daily mobility.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. responsive to levodopa (self-reported)
3. Hoehn \& Yahr stages I-III;
4. ages 55-85 years old
5. ability to follow directions in order to participate in testing procedures and exercise classes
6. free of any medical conditions or medication that contraindicates participation in an exercise program
7. willing and able to participate in rehabilitation intervention approximately 3x/week for 4 weeks while also refraining from making changes to medications (as reasonable) or to other exercise programs during the study period.
Exclusion Criteria
2. no medical condition that precludes exercise
3. cognitive inability to participate in an exercise program, such as MoCA score less than or equal to 19, prior diagnosis of dementia or inability to follow directions
4. recurrent fallers, defined as those who fall more than 3 times a week (from patient and caregiver recollection)
5. excessive use of alcohol or recreational drugs
6. recent change in medication
7. inability to stand and walk for ISAW without an assistive device.
55 Years
85 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Oregon Health and Science University
OTHER
Responsible Party
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Laurie King
Professor
Principal Investigators
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Laurie A King, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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References
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King LA, Mancini M, Smulders K, Harker G, Lapidus JA, Ramsey K, Carlson-Kuhta P, Fling BW, Nutt JG, Peterson DS, Horak FB. Cognitively Challenging Agility Boot Camp Program for Freezing of Gait in Parkinson Disease. Neurorehabil Neural Repair. 2020 May;34(5):417-427. doi: 10.1177/1545968320909331. Epub 2020 Apr 4.
Shah VV, McNames J, Mancini M, Carlson-Kuhta P, Spain RI, Nutt JG, El-Gohary M, Curtze C, Horak FB. Quantity and quality of gait and turning in people with multiple sclerosis, Parkinson's disease and matched controls during daily living. J Neurol. 2020 Apr;267(4):1188-1196. doi: 10.1007/s00415-020-09696-5. Epub 2020 Jan 11.
Shah VV, McNames J, Mancini M, Carlson-Kuhta P, Nutt JG, El-Gohary M, Lapidus JA, Horak FB, Curtze C. Digital Biomarkers of Mobility in Parkinson's Disease During Daily Living. J Parkinsons Dis. 2020;10(3):1099-1111. doi: 10.3233/JPD-201914.
Mancini M, King L, Salarian A, Holmstrom L, McNames J, Horak FB. Mobility Lab to Assess Balance and Gait with Synchronized Body-worn Sensors. J Bioeng Biomed Sci. 2011 Dec 12;Suppl 1:007. doi: 10.4172/2155-9538.S1-007.
El-Gohary M, Pearson S, McNames J, Mancini M, Horak F, Mellone S, Chiari L. Continuous monitoring of turning in patients with movement disability. Sensors (Basel). 2013 Dec 27;14(1):356-69. doi: 10.3390/s140100356.
Hasegawa N, Shah VV, Harker G, Carlson-Kuhta P, Nutt JG, Lapidus JA, Jung SH, Barlow N, King LA, Horak FB, Mancini M. Responsiveness of Objective vs. Clinical Balance Domain Outcomes for Exercise Intervention in Parkinson's Disease. Front Neurol. 2020 Sep 25;11:940. doi: 10.3389/fneur.2020.00940. eCollection 2020.
King LA, Horak FB. Delaying mobility disability in people with Parkinson disease using a sensorimotor agility exercise program. Phys Ther. 2009 Apr;89(4):384-93. doi: 10.2522/ptj.20080214. Epub 2009 Feb 19.
King LA, Salarian A, Mancini M, Priest KC, Nutt J, Serdar A, Wilhelm J, Schlimgen J, Smith M, Horak FB. Exploring outcome measures for exercise intervention in people with Parkinson's disease. Parkinsons Dis. 2013;2013:572134. doi: 10.1155/2013/572134. Epub 2013 Apr 30.
King LA, Wilhelm J, Chen Y, Blehm R, Nutt J, Chen Z, Serdar A, Horak FB. Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. J Neurol Phys Ther. 2015 Oct;39(4):204-12. doi: 10.1097/NPT.0000000000000101.
Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.
Leddy AL, Crowner BE, Earhart GM. Utility of the Mini-BESTest, BESTest, and BESTest sections for balance assessments in individuals with Parkinson disease. J Neurol Phys Ther. 2011 Jun;35(2):90-7. doi: 10.1097/NPT.0b013e31821a620c.
Chen YY, Guan BS, Li ZK, Yang QH, Xu TJ, Li HB, Wu QY. Application of telehealth intervention in Parkinson's disease: A systematic review and meta-analysis. J Telemed Telecare. 2020 Jan-Feb;26(1-2):3-13. doi: 10.1177/1357633X18792805. Epub 2018 Aug 28.
Silva-Batista C, Wilhelm JL, Scanlan KT, Stojak M, Carlson-Kuhta P, Chen S, Liu W, de la Huerta TNG, Horak FB, Mancini M, King LA. Balance telerehabilitation and wearable technology for people with Parkinson's disease (TelePD trial). BMC Neurol. 2023 Oct 13;23(1):368. doi: 10.1186/s12883-023-03403-3.
Study Documents
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Document Type: Study Protocol
Data will be gathered from questionnaires and instrumented assessments, and entered into the web-based Research Electronic Data Capture system (REDCap) and into the OHSU Balance Disorders database. REDCap is a secure electronic database administered by OHSU. Hard copies of these records will be stored behind a locked office in a locked cabinet at OHSU. The de-identified Mobility Lab data will be collected on a password-protected and data-encrypted laptop computer and uploaded after each test session to an OHSU secure server, where the Balance Disorders database is located.
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