Parkinson DiseaseNCT06246747
The Use of Telerehabilitation to Improve Movement Outcomes for Patients With Parkinson Disease
A study testing In clinic physical therapy and Telerehabilitation only in people with Parkinson Disease, run by Wizecare at 1 site in United States.
Trial summary
The goal of this pilot randomized clinical trial was to assess the feasibility of telerehabilitation (TR) for patients with Parkinson\'s Disease (PD). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- In clinic physical therapy and Telerehabilitation only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 23 Jan 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 with PD of any duration
- The patient was scheduled for a new episode of physical therapy.
Who cannot join
- Any outpatient physical therapy episode in the preceding 5 months
- Documented diagnosis of another progressive neurological disease
- History of epilepsy
- Moderate to severe cognitive impairment
- Hemiparesis or hemiplegia
- Current complaints of dizziness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Telerehabilitation to Improve Movement-related Outcomes and Quality of Life for Patients With Parkinson's Disease: A Pilot Randomized Controlled Trial
The goal of this pilot randomized clinical trial was to assess the feasibility of telerehabilitation (TR) for patients with Parkinson\'s Disease (PD). The main questions it aims to answer are: 1. whether the recruitment to such a study will be successful and the satisfaction of both participants and clinicians will be good. 2. Clinical effectiveness of TR for patients with PD was also explored. Participants were randomized to 3 groups : 1. Clinic+TR. 2. TR-only group and 3. A usual control group. Results were compared between the groups.
Read the detailed description
Patients were identified for pre-screening if they had a diagnosis of PD for any duration and were scheduled for a new episode of physical therapy. Pre-screening included chart review by a study coordinator. The exclusion criteria were: any outpatient physical therapy episode in the preceding 5 months, documented diagnosis of another progressive neurological disease, history of epilepsy, moderate to severe cognitive impairment, hemiparesis or hemiplegia, current complaints of dizziness. Though not an a priori criterion, some patients could not be scheduled for study participation due to a lack of availability on the schedules of participating therapists.
Those meeting eligibility criteria were contacted in writing (via mailed letter or electronic health record portal) then via phone by a coordinator two to four weeks prior to their initial physical therapy visit. At pre-screen phone call, patients were excluded if they were not reached, reported not having a reliable caregiver or internet connection in their home, or declined to participate.
After chart review and phone screening, those interested in participation were consented in-person by the study coordinator and further screened for eligibility by the evaluating physical therapist immediately prior to their initial physical therapy visit. Final eligibility was determined by completion of the timed-up-and-go test (TUG) less than15 seconds, a 10-meter gait speed of more than 0.8 m/s, and a subjective determination of safety by the evaluating physical therapist.
The primary intervention of interest in this study was the delivery of physical therapist interventions using a TR platform (WizeCare Technologies, Or Yehuda, Israel). Patients completed TR on a tablet (Lenovo Yoga Tab 3, Model YT3-X50F, OS Android 6.0) provided by WizeCare, their own tablet, their own laptop or desktop computer, or their own cell phone. If by tablet or cell phone, the platform was accessed using a mobile app. If by computer, the platform was accessed via the internet.
The WizeCare TR platform enables remote rehabilitation training and monitoring using a customized combination of video conferencing and libraries of pre-recorded videos of specific exercises. These videos can be combined manually to create unique exercise plans for patients that vary in content and duration. Immediately prior to this study, a series of videos of common PD-specific exercises were produced and stored in a specific library on the platform. Physical therapists built customized home exercise programs primarily from this library, though videos from any library were available for use. The platform also features an option for live video calls between patients and therapists, which enabled ongoing communication and re-evaluation for manual adjustment of the rehabilitation plan as needed.
Baseline demographic variables were age and gender. Baseline clinical variables were years since PD diagnosis, the modified Hoehn and Yahr scale, and the Unified Parkinson's Disease Rating Scale (UPDRS). Hoehn and Yahr stages range from 1 (unilateral involvement only) to 5 (wheelchair-bound or bedridden unless aided), with the modified scale including stages 1.5 and 2.5 to account for intermediate phases of disease progression. The UPDRS is a clinician-rated instrument of observable PD symptoms that are assessed for four different constructs: mental dysfunction and mood, activities of daily living, motor function, and treatment-related complications; higher UPDRS total scores indicate greater symptom severity.
At each interaction with the treating physical therapist-in clinic or via the TR platform-subjective feedback was provided verbally by the patient regarding the safety of the exercises he or she completed at home. This is consistent with current standard practice. Any reported fall or other adverse event, whether in conjunction with the exercise program or otherwise, was reviewed by the study team (the four treating physical therapists and the PI). These were recorded and reported to the Institutional Review Board as required.
Additionally, the WizeCare platform enables a safety assessment with each session in which a patient interacts with the system, including their unsupervised home exercise sessions. At the conclusion of each session on the platform, patients are asked, "Did the patient feel safe during this session?" If they answer "No", the system can send an automated message to the treating physical therapist. The system also provides an automated response to the patient to, "Please stop participating in the exercise program and call the treating physical therapist." Initiated by either the physical therapist or the patient within 24 hours of the reported lack of safety, a conversation between them will allow the patient to express their safety concerns. Any such events were recorded as adverse events, with subsequent steps as outlined above. These patient self-reports of safety were included amongst exploratory outcomes.
- Conditions
- Parkinson Disease
- Being tested
- In clinic physical therapy, Telerehabilitation only
- Keywords
- Parkinson Disease, physical therapy, telerehabilitation, satisfaction, adherence to home exercise
- Medical subject headings
- Parkinson Disease, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In clinic physical therapyOther
Patients visit the clinic to receive traditional physical therapy treatment
Telerehabilitation onlyOther
Also called Wizecare Telerehabilitation Platform
Patients receive remote treatment using the Wizecare platform
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy treatment in the clinic + telerehabilitation | Experimental | Patients performed treatments in the clinic in the presence of their physical therapist (PT) as well as perform remote treatment from their homes. The remote treatment included using video chat with their PT as well as performing PD-specific exercises which were stored in a specific library on the platform. Receives: Other: In clinic physical therapy; Other: Telerehabilitation only |
| TR-only | Experimental | Patients received treatment at their homes using the TR platform. This included video chat with their clinician as well as performing PD-specific exercises which were stored in a specific library on the platform. Receives: Other: Telerehabilitation only |
| Control group | Active comparator | Patients received treatment in the clinic in the presence of their PT Receives: Other: In clinic physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction assessment
We assessed satisfaction with the mode of care delivery using novel surveys, which were administered to the patient and the physical therapist at the in-clinic discharge visit via the Research Electronic Data Captureapture (REDCap) platform. Each survey assessed eight constructs; six satisfaction items were rated on a 5-point Likert scale ("very poor", "poor", "fair", "good", or "very good"). The number 1 stood for "very poor" and the number 5 stood for "very good". The item pertaining to safety asked for a 0 ("very unsafe") to 100 ("very safe") rating.
Measured: From enrollment to end of treatment at 5 weeks
Secondary outcomes (1)
Clinical effectiveness of TR
Clinical effectiveness was measured by the Parkinson's Disease Questionnaire (PDQ-39) which is a self-reported questionnaire. It consists of 39 items across eight domains: Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort. Each item is rated on a scale from 0 to 4, with 0 representing no difficulty and 4 representing severe difficulty. Scores are calculated by summing the responses for each domain and transforming them into a score ranging from 0 to 100, with higher scores indicating worse quality of life.
Measured: From enrollment to end of treatment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Feb 2020
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wizecare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Stilphen, PT, DPT, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246747
- Sponsor's protocol ID
- 00005367
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reynolds GO, Otto MW, Ellis TD, Cronin-Golomb A. The Therapeutic Potential of Exercise to Improve Mood, Cognition, and Sleep in Parkinson's Disease. Mov Disord. 2016 Jan;31(1):23-38. doi: 10.1002/mds.26484. Epub 2015 Dec 30.
PubMed 26715466van der Kolk NM, King LA. Effects of exercise on mobility in people with Parkinson's disease. Mov Disord. 2013 Sep 15;28(11):1587-96. doi: 10.1002/mds.25658.
PubMed 24132847Goodwin VA, Richards SH, Taylor RS, Taylor AH, Campbell JL. The effectiveness of exercise interventions for people with Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2008 Apr 15;23(5):631-40. doi: 10.1002/mds.21922.
PubMed 18181210Corcos DM, Robichaud JA, David FJ, Leurgans SE, Vaillancourt DE, Poon C, Rafferty MR, Kohrt WM, Comella CL. A two-year randomized controlled trial of progressive resistance exercise for Parkinson's disease. Mov Disord. 2013 Aug;28(9):1230-40. doi: 10.1002/mds.25380. Epub 2013 Mar 27.
PubMed 23536417Shulman LM, Katzel LI, Ivey FM, Sorkin JD, Favors K, Anderson KE, Smith BA, Reich SG, Weiner WJ, Macko RF. Randomized clinical trial of 3 types of physical exercise for patients with Parkinson disease. JAMA Neurol. 2013 Feb;70(2):183-90. doi: 10.1001/jamaneurol.2013.646.
PubMed 23128427Wu PL, Lee M, Huang TT. Effectiveness of physical activity on patients with depression and Parkinson's disease: A systematic review. PLoS One. 2017 Jul 27;12(7):e0181515. doi: 10.1371/journal.pone.0181515. eCollection 2017.
PubMed 28749970Ahlskog JE. Does vigorous exercise have a neuroprotective effect in Parkinson disease? Neurology. 2011 Jul 19;77(3):288-94. doi: 10.1212/WNL.0b013e318225ab66.
PubMed 21768599King 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.
PubMed 26308937Ferraz DD, Trippo KV, Duarte GP, Neto MG, Bernardes Santos KO, Filho JO. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial. Arch Phys Med Rehabil. 2018 May;99(5):826-833. doi: 10.1016/j.apmr.2017.12.014. Epub 2018 Jan 11.
PubMed 29337023Qiang JK, Marras C. Telemedicine in Parkinson's disease: A patient perspective at a tertiary care centre. Parkinsonism Relat Disord. 2015 May;21(5):525-8. doi: 10.1016/j.parkreldis.2015.02.018. Epub 2015 Feb 28.
PubMed 25791380Wilkinson JR, Spindler M, Wood SM, Marcus SC, Weintraub D, Morley JF, Stineman MG, Duda JE. High patient satisfaction with telehealth in Parkinson disease: A randomized controlled study. Neurol Clin Pract. 2016 Jun;6(3):241-251. doi: 10.1212/CPJ.0000000000000252.
PubMed 27347441Dorsey ER, Vlaanderen FP, Engelen LJ, Kieburtz K, Zhu W, Biglan KM, Faber MJ, Bloem BR. Moving Parkinson care to the home. Mov Disord. 2016 Sep;31(9):1258-62. doi: 10.1002/mds.26744. Epub 2016 Aug 8.
PubMed 27501323Fullard ME, Thibault DP, Hill A, Fox J, Bhatti DE, Burack MA, Dahodwala N, Haberfeld E, Kern DS, Klepitskava OS, Urrea-Mendoza E, Myers P, Nutt J, Rafferty MR, Schwalb JM, Shulman LM, Willis AW; Parkinson Study Group Healthcare Outcomes and Disparities Working Group. Utilization of rehabilitation therapy services in Parkinson disease in the United States. Neurology. 2017 Sep 12;89(11):1162-1169. doi: 10.1212/WNL.0000000000004355. Epub 2017 Aug 23.
PubMed 28835397Prvu Bettger J, Resnik LJ. Telerehabilitation in the Age of COVID-19: An Opportunity for Learning Health System Research. Phys Ther. 2020 Oct 30;100(11):1913-1916. doi: 10.1093/ptj/pzaa151. No abstract available.
PubMed 32814976Middleton A, Simpson KN, Bettger JP, Bowden MG. COVID-19 Pandemic and Beyond: Considerations and Costs of Telehealth Exercise Programs for Older Adults With Functional Impairments Living at Home-Lessons Learned From a Pilot Case Study. Phys Ther. 2020 Aug 12;100(8):1278-1288. doi: 10.1093/ptj/pzaa089.
PubMed 32372072
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Telerehabilitation to Improve Movement-related Outcomes and Quality of Life for Patients With Parkinson's Disease: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06246747
- Acronym / sponsor ID
- 00005367
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, physical therapy, telerehabilitation, satisfaction, adherence to home exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- WizecareIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 7 Feb 2024 (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.
The goal of this pilot randomized clinical trial was to assess the feasibility of telerehabilitation (TR) for patients with Parkinson\'s Disease (PD). The main questions it aims to answer are: 1. whether the recruitment to such a study will be successful and the satisfaction of both participants and clinicians will be good. 2. Clinical effectiveness of TR for patients with PD was also explored. Participants were randomized to 3 groups : 1. Clinic+TR. 2. TR-only group and 3. A usual control group. Results were compared between the groups.
Detailed description
Patients were identified for pre-screening if they had a diagnosis of PD for any duration and were scheduled for a new episode of physical therapy. Pre-screening included chart review by a study coordinator. The exclusion criteria were: any outpatient physical therapy episode in the preceding 5 months, documented diagnosis of another progressive neurological disease, history of epilepsy, moderate to severe cognitive impairment, hemiparesis or hemiplegia, current complaints of dizziness. Though not an a priori criterion, some patients could not be scheduled for study participation due to a lack of availability on the schedules of participating therapists.
Those meeting eligibility criteria were contacted in writing (via mailed letter or electronic health record portal) then via phone by a coordinator two to four weeks prior to their initial physical therapy visit. At pre-screen phone call, patients were excluded if they were not reached, reported not having a reliable caregiver or internet connection in their home, or declined to participate.
After chart review and phone screening, those interested in participation were consented in-person by the study coordinator and further screened for eligibility by the evaluating physical therapist immediately prior to their initial physical therapy visit. Final eligibility was determined by completion of the timed-up-and-go test (TUG) less than15 seconds, a 10-meter gait speed of more than 0.8 m/s, and a subjective determination of safety by the evaluating physical therapist.
The primary intervention of interest in this study was the delivery of physical therapist interventions using a TR platform (WizeCare Technologies, Or Yehuda, Israel). Patients completed TR on a tablet (Lenovo Yoga Tab 3, Model YT3-X50F, OS Android 6.0) provided by WizeCare, their own tablet, their own laptop or desktop computer, or their own cell phone. If by tablet or cell phone, the platform was accessed using a mobile app. If by computer, the platform was accessed via the internet.
The WizeCare TR platform enables remote rehabilitation training and monitoring using a customized combination of video conferencing and libraries of pre-recorded videos of specific exercises. These videos can be combined manually to create unique exercise plans for patients that vary in content and duration. Immediately prior to this study, a series of videos of common PD-specific exercises were produced and stored in a specific library on the platform. Physical therapists built customized home exercise programs primarily from this library, though videos from any library were available for use. The platform also features an option for live video calls between patients and therapists, which enabled ongoing communication and re-evaluation for manual adjustment of the rehabilitation plan as needed.
Baseline demographic variables were age and gender. Baseline clinical variables were years since PD diagnosis, the modified Hoehn and Yahr scale, and the Unified Parkinson's Disease Rating Scale (UPDRS). Hoehn and Yahr stages range from 1 (unilateral involvement only) to 5 (wheelchair-bound or bedridden unless aided), with the modified scale including stages 1.5 and 2.5 to account for intermediate phases of disease progression. The UPDRS is a clinician-rated instrument of observable PD symptoms that are assessed for four different constructs: mental dysfunction and mood, activities of daily living, motor function, and treatment-related complications; higher UPDRS total scores indicate greater symptom severity.
At each interaction with the treating physical therapist-in clinic or via the TR platform-subjective feedback was provided verbally by the patient regarding the safety of the exercises he or she completed at home. This is consistent with current standard practice. Any reported fall or other adverse event, whether in conjunction with the exercise program or otherwise, was reviewed by the study team (the four treating physical therapists and the PI). These were recorded and reported to the Institutional Review Board as required.
Additionally, the WizeCare platform enables a safety assessment with each session in which a patient interacts with the system, including their unsupervised home exercise sessions. At the conclusion of each session on the platform, patients are asked, "Did the patient feel safe during this session?" If they answer "No", the system can send an automated message to the treating physical therapist. The system also provides an automated response to the patient to, "Please stop participating in the exercise program and call the treating physical therapist." Initiated by either the physical therapist or the patient within 24 hours of the reported lack of safety, a conversation between them will allow the patient to express their safety concerns. Any such events were recorded as adverse events, with subsequent steps as outlined above. These patient self-reports of safety were included amongst exploratory outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical therapy treatment in the clinic + telerehabilitation | Experimental | Other: In clinic physical therapy, Other: Telerehabilitation onlyPatients performed treatments in the clinic in the presence of their physical therapist (PT) as well as perform remote treatment from their homes. The remote treatment included using video chat with their PT as well as performing PD-specific exercises which were stored in a specific library on the platform. |
| TR-only | Experimental | Other: Telerehabilitation onlyPatients received treatment at their homes using the TR platform. This included video chat with their clinician as well as performing PD-specific exercises which were stored in a specific library on the platform. |
| Control group | Active comparator | Other: In clinic physical therapyPatients received treatment in the clinic in the presence of their PT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient older than 18 with PD of any duration
- The patient was scheduled for a new episode of physical therapy.
Key exclusion criteria (6 listed)
- Any outpatient physical therapy episode in the preceding 5 months
- Documented diagnosis of another progressive neurological disease
- History of epilepsy
- Moderate to severe cognitive impairment
- Hemiparesis or hemiplegia
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 |
|---|---|---|
| In clinic physical therapyPatients visit the clinic to receive traditional physical therapy treatment | Other | Control group, Physical therapy treatment in the clinic + telerehabilitation |
| Telerehabilitation onlyAlso: Wizecare Telerehabilitation PlatformPatients receive remote treatment using the Wizecare platform | Other | Physical therapy treatment in the clinic + telerehabilitation, TR-only |
Primary outcome
Satisfaction assessment
Time frame: From enrollment to end of treatment at 5 weeks
We assessed satisfaction with the mode of care delivery using novel surveys, which were administered to the patient and the physical therapist at the in-clinic discharge visit via the Research Electronic Data Captureapture (REDCap) platform. Each survey assessed eight constructs; six satisfaction items were rated on a 5-point Likert scale ("very poor", "poor", "fair", "good", or "very good"). The number 1 stood for "very poor" and the number 5 stood for "very good". The item pertaining to safety asked for a 0 ("very unsafe") to 100 ("very safe") rating.
1 secondary outcome
Clinical effectiveness of TR
Time frame: From enrollment to end of treatment at 5 weeks
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 15 Mar 2024.
- Background: PubMed 26715466Reynolds GO, Otto MW, Ellis TD, Cronin-Golomb A. The Therapeutic Potential of Exercise to Improve Mood, Cognition, and Sleep in Parkinson's Disease. Mov Disord. 2016 Jan;31(1):23-38. doi: 10.1002/mds.26484. Epub 2015 Dec 30.
- Background: PubMed 24132847van der Kolk NM, King LA. Effects of exercise on mobility in people with Parkinson's disease. Mov Disord. 2013 Sep 15;28(11):1587-96. doi: 10.1002/mds.25658.
- Background: PubMed 18181210Goodwin VA, Richards SH, Taylor RS, Taylor AH, Campbell JL. The effectiveness of exercise interventions for people with Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2008 Apr 15;23(5):631-40. doi: 10.1002/mds.21922.
- Background: PubMed 23536417Corcos DM, Robichaud JA, David FJ, Leurgans SE, Vaillancourt DE, Poon C, Rafferty MR, Kohrt WM, Comella CL. A two-year randomized controlled trial of progressive resistance exercise for Parkinson's disease. Mov Disord. 2013 Aug;28(9):1230-40. doi: 10.1002/mds.25380. Epub 2013 Mar 27.
- Background: PubMed 23128427Shulman LM, Katzel LI, Ivey FM, Sorkin JD, Favors K, Anderson KE, Smith BA, Reich SG, Weiner WJ, Macko RF. Randomized clinical trial of 3 types of physical exercise for patients with Parkinson disease. JAMA Neurol. 2013 Feb;70(2):183-90. doi: 10.1001/jamaneurol.2013.646.
- Background: PubMed 28749970Wu PL, Lee M, Huang TT. Effectiveness of physical activity on patients with depression and Parkinson's disease: A systematic review. PLoS One. 2017 Jul 27;12(7):e0181515. doi: 10.1371/journal.pone.0181515. eCollection 2017.
- Background: PubMed 21768599Ahlskog JE. Does vigorous exercise have a neuroprotective effect in Parkinson disease? Neurology. 2011 Jul 19;77(3):288-94. doi: 10.1212/WNL.0b013e318225ab66.
- Background: PubMed 26308937King 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.
- Background: PubMed 29337023Ferraz DD, Trippo KV, Duarte GP, Neto MG, Bernardes Santos KO, Filho JO. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial. Arch Phys Med Rehabil. 2018 May;99(5):826-833. doi: 10.1016/j.apmr.2017.12.014. Epub 2018 Jan 11.
- Background: PubMed 25791380Qiang JK, Marras C. Telemedicine in Parkinson's disease: A patient perspective at a tertiary care centre. Parkinsonism Relat Disord. 2015 May;21(5):525-8. doi: 10.1016/j.parkreldis.2015.02.018. Epub 2015 Feb 28.
- Background: PubMed 27347441Wilkinson JR, Spindler M, Wood SM, Marcus SC, Weintraub D, Morley JF, Stineman MG, Duda JE. High patient satisfaction with telehealth in Parkinson disease: A randomized controlled study. Neurol Clin Pract. 2016 Jun;6(3):241-251. doi: 10.1212/CPJ.0000000000000252.
- Background: PubMed 27501323Dorsey ER, Vlaanderen FP, Engelen LJ, Kieburtz K, Zhu W, Biglan KM, Faber MJ, Bloem BR. Moving Parkinson care to the home. Mov Disord. 2016 Sep;31(9):1258-62. doi: 10.1002/mds.26744. Epub 2016 Aug 8.
- Individual participant dataSharing planned: No
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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.
Mary Stilphen, PT, DPT principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In clinic physical therapy and Telerehabilitation only in people with Parkinson Disease, run by Wizecare 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 2 inclusion and 6 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 15 Mar 2024. 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?
Satisfaction assessment (time frame: From enrollment to end of treatment at 5 weeks). 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 NCT06246747, which also lists 38 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 15 Mar 2024.