Parkinson DiseaseTelerehabPDNCT04600011
Telerehabilitation for Parkinson's Disease
A study testing Physical and occupational therapy (PT/OT) and Home Safety Evaluation (HSE) in people with Parkinson Disease and Telemedicine, run by Rush University Medical Center at 1 site in United States.
Trial summary
Our primary objective in this 10-week pilot study is to demonstrate the feasibility of using videoconferencing technology to provide Parkinson's Disease (PD) patients, alongside their supervising care partners, specialized physical and occupational therapy (PT/OT) focused on neurorehabilitation that ultimately aims to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Telemedicine
- What is being tested?
- Physical and occupational therapy (PT/OT) and Home Safety Evaluation (HSE)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 15 Jun 2021
- 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
Subject Inclusion Criteria:
- Subject's age is greater than or equal to 18.
- Subject has a diagnosis of Idiopathic Parkinson's Disease according to established criteria and this has been confirmed by a Movement Disorders Neurologist.
- Subject's Movement Disorders Neurologist believes he/she would benefit from specialized physical and occupational therapy to reduce fall risk.
- Subject's Idiopathic Parkinson's Disease is Hoehn and Yahr stage 2 or 3 in the "OFF"-medication state (stage 2 defined by bilateral or midline symptoms with less than or equal to 2 steps back on the pull test with self-recovery; stage 3 is defined by more than 2 steps back on the pull test with or without self-recovery, or no steps back and requiring assistance to recover).
- Subject demonstrates the ability to utilize the virtual platform at their initial in-person evaluation.
- Subject has been on a stable medication regimen for the treatment of Idiopathic Parkinson's Disease for the month preceding the baseline in-person visit, and has the ability to maintain stable dosing for the duration of the 10-week primary intervention.
- Subject has home Wi-Fi access for the tele-neurorehabilitation home visits and a personal tablet with Wi-Fi connectivity.
Care Partner Inclusion Criteria:
- Care partner's age is greater than or equal to 18.
- Care partner has been the primary caregiver for >6 months and will remain so for at least 10 weeks to the study subject.
- Care partner has the ability and desire to participate in all of the study visits with the study subject, including the tele-neurorehabilitation home visits.
- Care partner has the ability and desire to provide stand-by assistance, but in the setting of a gait belt, to the study subject during tele-neurorehabilitation home visits.
Subject Exclusion Criteria:
- Subject is non-English speaking.
- Subject has only a provisional diagnosis of Idiopathic Parkinson's Disease or atypical features suggestive of an alternative diagnosis.
- Subject has and additional significant neurologic diagnosis that may render him/her with neurologic deficits that may affect gait and balance.
- Subject has another destabilizing chronic medical condition which may warrant frequent hospitalization or render the patient unable to participate in physical activity.
- Subject requires more than just stand-by assistance for gait and balance.
- Subject is reliant on mobility devices to walk (walkers, cane, walking sticks, motorized scooter, etc).
- Subject is receiving physical therapy elsewhere during the month preceding the study and during the duration of the study.
- Subject has no care partner available to participate in all of the study visits.
- Subject is unable to follow direction or consent to research.
- Subject is unable to commit to the study-related activities and/or schedule of events.
Care Partner Exclusion Criteria:
- Care partner is non-English speaking.
- Care partner is unable to follow direction or consent to research.
- Care partner is unable to commit to the study-related activities and/or schedule of events.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Novel Tele-Neurorehabilitation Program Aimed at Reducing Fall Risk in Parkinson's Disease Patients
Our primary objective in this 10-week pilot study is to demonstrate the feasibility of using videoconferencing technology to provide Parkinson's Disease (PD) patients, alongside their supervising care partners, specialized physical and occupational therapy (PT/OT) focused on neurorehabilitation that ultimately aims to reduce fall risk. This therapy is similar to what a PD patient could receive in-person with neurologic-certified physical therapists and occupational therapists with significant experience working with PD patients and addressing their needs, but it is delivered through a virtual platform. Feasibility is defined by measures of adherence, retention, and safety.
The specialized PT and OT measurement tools and strategies used in this study are in-line with the most current formal evidence-based guidelines/recommendations available for therapy in PD: European Physiotherapy Guideline for Parkinson's Disease, Parkinson Evidence Database to Guide Effectiveness (PD-EDGE) Task Force and Guidelines for Occupational Therapy in Parkinson's Disease Rehabilitation.
The study duration is approximately 10 weeks of the primary telerehabilitation intervention and a 2 follow-up phone calls at the 3- and 6-month timepoints. There will be one baseline in-person evaluation and one final in-person evaluation following the completion of all televisits. The enrollment target is up to 15-20 patient and care partner (P+CP) pairs, meaning 30-40 subjects total. There are no controls for this study.
Read the detailed description
Gait dysfunction, postural instability, and freezing-of-gait (FOG) ultimately develop in about 80% of PD patients, which lead to falls and advancing disability. This is significant because the consequences of falls are far-reaching: accelerating immobility due to heightened fear-of-falling, reducing quality of life and independence, and increasing healthcare utilization and costs. Thus, there is an urgent need to expand evidence- based outpatient neurologic-PT/OT services to community-dwelling PD patients to reduce fall risk.
This research proposal will address this unmet need by determining whether tele-neurorehabilitation is a care model that can be executed safety for PD patients to provide these services from well-trained therapists who are not easily accessible otherwise. This feasibility data is critical in the development of a novel tele-neurorehabilitation protocol and randomized-controlled efficacy trial thereafter.
The impact of the intended research is to demonstrate the feasibility and preliminary efficacy of this novel teleconferencing-based delivery of gait and balance exercises/strategies with guided instruction much like one would receive in-person but in the comfort of one's own home. By demonstrating the feasibility and preliminary efficacy of this pilot program, subsequent long-term goals are to apply for larger sources of funding to sustain the program. By leveraging the data gained from these studies it is anticipated the practice of telerehabilitation will be expanded and improved; and ultimately its efficacy to health care policy providers and insurers for potential reimbursement will be demonstrated.
The researchers intend to enroll 15-20 individuals with mild-moderate PD into our proposed novel telerehabilitation program, where patients will receive tele-PT/OT home visits and home-safety surveillance with neurologic-specialized therapists who are experienced with the core problem areas seen in PD patients. The intended clinical impact is to improve gait/balance function and postural stability, and thus reduce falls in patients with PD. With the remote telecommunications intervention, we aim to enable the additional clinical impact of expanding access to therapy for people with PD that otherwise would have significant difficulty obtaining this type of multiple-visit, individually-tailored, and specialized therapy care due to travel burden and cost.
- Conditions
- Parkinson Disease, Telemedicine
- Being tested
- Physical and occupational therapy (PT/OT), Home Safety Evaluation (HSE)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical and occupational therapy (PT/OT)Other
Neurologic-specialized and -certified physical and occupational therapists will provide each participant with an initial in-person PT/OT evaluation/treatment session with oversight from a Movement Disorders Neurologist, followed by 4 "virtual home visits" with tele-PT/OT and care partner supervision every 2 weeks, and culminating with a final in-person evaluation, all with a focus on personalized training in core areas contributing to a patient's individual fall risk, much like in-person visits. Virtual home safety surveillance with the mobile virtual platform is an additional feature of this intervention that aims to optimize the home environment to reduce external factors contributing to fall risk.
Home Safety Evaluation (HSE)Other
The VIRTUAL HOME SAFETY EVALUTIONS (HSE)-ONLY ARM where participants ONLY receive the virtual home safety evaluations and surveillance that are built into the original protocol of three of the four tele-OT visits that is being used in Arm 1. The study duration for Arm 2 is about 6 weeks of the primary intervention as described with 3-month and 6-month follow-up calls. The mobile virtual platform for Arm 2 is comprised of a tablet OR smartphone that will be guided through the home by the care partner only and not the patient.
| Study group | Role | What they receive |
|---|---|---|
| TELEREHABILITATION ARM | Other | ARM 1: The TELEREHABILITATION ARM where participants receive the full originally-intended protocol that includes one initial in-person PT/OT evaluation, four virtual PT/OT visits, and one final in-person (or virtual, if in-person is not possible) PT/OT evaluation. The study duration for Arm 1 is about 10 weeks of the primary intervention as described with 3- and 6-month follow-up calls. The mobile virtual platform for Arm 1 is comprised of a tablet on a height-adjustable rotating tablet floor stand with a gooseneck and wheels. Receives: Other: Physical and occupational therapy (PT/OT) |
| VIRTUAL HOME SAFETY EVALUATIONS (HSE)-ONLY ARM | Other | ARM 2: The VIRTUAL HOME SAFETY EVALUTIONS (HSE)-ONLY ARM where participants ONLY receive the virtual home safety evaluations and surveillance that are built into the original protocol of three of the four tele-OT visits that is being used in Arm 1. The study duration for Arm 2 is about 6 weeks of the primary intervention as described with 3-month and 6-month follow-up calls. The mobile virtual platform for Arm 2 is comprised of a tablet OR smartphone that will be guided through the home by the care partner only and not the patient. Receives: Other: Home Safety Evaluation (HSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Measure - 1:
(1) The proportion of scheduled protocol-driven tele-PT and tele-OT visits that were completed.
Measured: Through study completion of approximately 18 months.
Adherence Measure - 2:
(2) The proportion of scheduled protocol-driven PT/OT exercises/activities that could be completed virtually as assessed by the instructing study therapist.
Measured: Through study completion of approximately 18 months.
Adherence Measure - 3:
(3) Qualitative categorization of limitations in performing tele-PT and tele-OT visits and PT/OT exercises/activities virtually into patient-related, technology-related, or environmentally-related limitations
Measured: Through study completion of approximately 18 months.
Retention Measures:
The proportion of patient and care partner (P+CP) pairs that enrolled and were able to complete the study, i.e. study drop-out rate.
Measured: Through study completion of approximately 18 months.
Safety Measures:
The number and nature of adverse and serious adverse events that occurred due to participation in the study, and the proportion deemed a result of study-related interventions.
Measured: Through study completion of approximately 18 months.
Secondary outcomes (13)
Goals Attainment Scale Score:
Change in Goals Attainment Scale score (GAS) from baseline across the 10-week program and at the 3- and 6-month follow-ups (Visits 1, 3, 5, 6, Follow-up Call 1-2) for 3 patient-specific PT goals under the following categories: gait/balance, strengthening, and physical endurance, and 2 patient-specific OT goals under the category of activities-of-daily-living/home safety, defined at the baseline assessment.
Measured: Through study completion of approximately 18 months.
Falls Diary;
The change in falls frequency using the Falls Diary from baseline across the 10-week program and at the 3- and 6-month follow-ups (Visits 1, 3, 5, 6, Follow-up Call 1-2).
Measured: Through study completion of approximately 18 months.
Activities-Specific Balance Scale:
The change in gait confidence from baseline using the Activities-Specific Balance Confidence scale (ABC scale) across the 10-week program and at the 3- and 6-month follow-ups (Visits 1, 2-6, Follow-Up Call 1-2)
Measured: Through study completion of approximately 18 months.
Five-Times Sit-to-Stand Test:
The change in postural stability from baseline using the Five-Times Sit-to-Stand test (FTSTS) across the 10-week program to be performed both in-person and virtually (Visits 1, 3, 5, 6).
Measured: Through study completion of approximately 18 months.
In-Person Objective Therapy Measure - 1:
The change in the following in-person assessment Mini-Balance Evaluation Systems Test (mini-BESTest) from baseline to post-intervention (Visits 1 and 6).
Measured: Through study completion of approximately 18 months.
In-Person Objective Therapy Measure - 2:
The change in the following in-person assessment Rapid Turns Test (RTT) from baseline to post-intervention (Visits 1 and 6).
Measured: Through study completion of approximately 18 months.
In-Person Objective Therapy Measure - 3:
The change in the following in-person assessment Timed Up and Go (TUG)from baseline to post-intervention (Visits 1 and 6).
Measured: Through study completion of approximately 18 months.
In-Person Objective Therapy Measures - 4:
The change in the following in-person assessment Timed Up and Go-Cognitive (TUG-Cognitive) from baseline to post-intervention (Visits 1 and 6).
Measured: Through study completion of approximately 18 months.
In-Person Objective Therapy Measure - 5:
The change in the following in-person assessment 10-Meter Walk Time (10MWT) from baseline to post-intervention (Visits 1 and 6).
Measured: Through study completion of approximately 18 months.
In-Person Objective Therapy Measures - 6:
The change in the following in-person assessment 2-Minute Walk Distance Test (2MWT) from baseline to post-intervention (Visits 1 and 6).
Measured: Through study completion of approximately 18 months.
Rapid Turns Test:
The change in freezing-of-gait from baseline using the Rapid Turns Test (RTT) across the 10-week program to be performed both in-person and virtually (Visits 1, 3, 5, and 6).
Measured: Through study completion of approximately 18 months.
Parkinson's Disease Questionnaire-39:
The change in quality-of-life (QOL) using the Parkinson's Disease Questionnaire-39 (PDQ-39) from baseline to post-intervention (Visits 1 and 6).
Measured: Through study completion of approximately 18 months.
Home Exercise Program:
The proportion of patients who were able to adhere to their recommended home exercise program (HEP) in between study visits as assessed by weekly coordinator phone calls.
Measured: Through study completion of approximately 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start21 Jan 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pilot feasibility study, non-controlled
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitra Afshari, Rush University Medical Center
- Investigators
- Mitra Afshari, MD, MPH, Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600011
- Sponsor's protocol ID
- 19050804-IRB01
- Acronym
- TelerehabPD
- Status last verified
- Sep 2021
- First submitted
- 7 Feb 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marras C, Beck JC, Bower JH, Roberts E, Ritz B, Ross GW, Abbott RD, Savica R, Van Den Eeden SK, Willis AW, Tanner CM; Parkinson's Foundation P4 Group. Prevalence of Parkinson's disease across North America. NPJ Parkinsons Dis. 2018 Jul 10;4:21. doi: 10.1038/s41531-018-0058-0. eCollection 2018.
PubMed 30003140Macht M, Kaussner Y, Moller JC, Stiasny-Kolster K, Eggert KM, Kruger HP, Ellgring H. Predictors of freezing in Parkinson's disease: a survey of 6,620 patients. Mov Disord. 2007 May 15;22(7):953-6. doi: 10.1002/mds.21458.
PubMed 17377927Hely MA, Morris JG, Reid WG, Trafficante R. Sydney Multicenter Study of Parkinson's disease: non-L-dopa-responsive problems dominate at 15 years. Mov Disord. 2005 Feb;20(2):190-9. doi: 10.1002/mds.20324.
PubMed 15551331Poewe W. The natural history of Parkinson's disease. J Neurol. 2006 Dec;253 Suppl 7:VII2-6. doi: 10.1007/s00415-006-7002-7.
PubMed 17131223Low V, Ben-Shlomo Y, Coward E, Fletcher S, Walker R, Clarke CE. Measuring the burden and mortality of hospitalisation in Parkinson's disease: A cross-sectional analysis of the English Hospital Episodes Statistics database 2009-2013. Parkinsonism Relat Disord. 2015 May;21(5):449-54. doi: 10.1016/j.parkreldis.2015.01.017. Epub 2015 Feb 17.
PubMed 25737205Wielinski CL, Erickson-Davis C, Wichmann R, Walde-Douglas M, Parashos SA. Falls and injuries resulting from falls among patients with Parkinson's disease and other parkinsonian syndromes. Mov Disord. 2005 Apr;20(4):410-415. doi: 10.1002/mds.20347.
PubMed 15580552Pressley JC, Louis ED, Tang MX, Cote L, Cohen PD, Glied S, Mayeux R. The impact of comorbid disease and injuries on resource use and expenditures in parkinsonism. Neurology. 2003 Jan 14;60(1):87-93. doi: 10.1212/wnl.60.1.87.
PubMed 12525724Afshari M, Hernandez AV, Joyce JM, Hauptschein AW, Trenkle KL, Stebbins GT, Goetz CG. A Novel Home-Based Telerehabilitation Program Targeting Fall Prevention in Parkinson Disease: A Preliminary Trial. Neurol Clin Pract. 2024 Feb;14(1):e200246. doi: 10.1212/CPJ.0000000000200246. Epub 2024 Jan 5.
PubMed 38213401
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Tele-Neurorehabilitation Program Aimed at Reducing Fall Risk in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT04600011
- Acronym / sponsor ID
- TelerehabPD / 19050804-IRB01
- Conditions
- Parkinson Disease, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 23 Oct 2020 (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.
Our primary objective in this 10-week pilot study is to demonstrate the feasibility of using videoconferencing technology to provide Parkinson's Disease (PD) patients, alongside their supervising care partners, specialized physical and occupational therapy (PT/OT) focused on neurorehabilitation that ultimately aims to reduce fall risk. This therapy is similar to what a PD patient could receive in-person with neurologic-certified physical therapists and occupational therapists with significant experience working with PD patients and addressing their needs, but it is delivered through a virtual platform. Feasibility is defined by measures of adherence, retention, and safety.
The specialized PT and OT measurement tools and strategies used in this study are in-line with the most current formal evidence-based guidelines/recommendations available for therapy in PD: European Physiotherapy Guideline for Parkinson's Disease, Parkinson Evidence Database to Guide Effectiveness (PD-EDGE) Task Force and Guidelines for Occupational Therapy in Parkinson's Disease Rehabilitation.
The study duration is approximately 10 weeks of the primary telerehabilitation intervention and a 2 follow-up phone calls at the 3- and 6-month timepoints. There will be one baseline in-person evaluation and one final in-person evaluation following the completion of all televisits. The enrollment target is up to 15-20 patient and care partner (P+CP) pairs, meaning 30-40 subjects total. There are no controls for this study.
Detailed description
Gait dysfunction, postural instability, and freezing-of-gait (FOG) ultimately develop in about 80% of PD patients, which lead to falls and advancing disability. This is significant because the consequences of falls are far-reaching: accelerating immobility due to heightened fear-of-falling, reducing quality of life and independence, and increasing healthcare utilization and costs. Thus, there is an urgent need to expand evidence- based outpatient neurologic-PT/OT services to community-dwelling PD patients to reduce fall risk.
This research proposal will address this unmet need by determining whether tele-neurorehabilitation is a care model that can be executed safety for PD patients to provide these services from well-trained therapists who are not easily accessible otherwise. This feasibility data is critical in the development of a novel tele-neurorehabilitation protocol and randomized-controlled efficacy trial thereafter.
The impact of the intended research is to demonstrate the feasibility and preliminary efficacy of this novel teleconferencing-based delivery of gait and balance exercises/strategies with guided instruction much like one would receive in-person but in the comfort of one's own home. By demonstrating the feasibility and preliminary efficacy of this pilot program, subsequent long-term goals are to apply for larger sources of funding to sustain the program. By leveraging the data gained from these studies it is anticipated the practice of telerehabilitation will be expanded and improved; and ultimately its efficacy to health care policy providers and insurers for potential reimbursement will be demonstrated.
The researchers intend to enroll 15-20 individuals with mild-moderate PD into our proposed novel telerehabilitation program, where patients will receive tele-PT/OT home visits and home-safety surveillance with neurologic-specialized therapists who are experienced with the core problem areas seen in PD patients. The intended clinical impact is to improve gait/balance function and postural stability, and thus reduce falls in patients with PD. With the remote telecommunications intervention, we aim to enable the additional clinical impact of expanding access to therapy for people with PD that otherwise would have significant difficulty obtaining this type of multiple-visit, individually-tailored, and specialized therapy care due to travel burden and cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot feasibility study, non-controlled
| Arm | Type | Receives |
|---|---|---|
| TELEREHABILITATION ARM | Other | Other: Physical and occupational therapy (PT/OT)ARM 1: The TELEREHABILITATION ARM where participants receive the full originally-intended protocol that includes one initial in-person PT/OT evaluation, four virtual PT/OT visits, and one final in-person (or virtual, if in-person is not possible) PT/OT evaluation. The study duration for Arm 1 is about 10 weeks of the primary intervention as described with 3- and 6-month follow-up calls. The mobile virtual platform for Arm 1 is comprised of a tablet on a height-adjustable rotating tablet floor stand with a gooseneck and wheels. |
| VIRTUAL HOME SAFETY EVALUATIONS (HSE)-ONLY ARM | Other | Other: Home Safety Evaluation (HSE)ARM 2: The VIRTUAL HOME SAFETY EVALUTIONS (HSE)-ONLY ARM where participants ONLY receive the virtual home safety evaluations and surveillance that are built into the original protocol of three of the four tele-OT visits that is being used in Arm 1. The study duration for Arm 2 is about 6 weeks of the primary intervention as described with 3-month and 6-month follow-up calls. The mobile virtual platform for Arm 2 is comprised of a tablet OR smartphone that will be guided through the home by the care partner only and not the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Physical and occupational therapy (PT/OT)Neurologic-specialized and -certified physical and occupational therapists will provide each participant with an initial in-person PT/OT evaluation/treatment session with oversight from a Movement Disorders Neurologist, followed by 4 "virtual home visits" with tele-PT/OT and care partner supervision every 2 weeks, and culminating with a final in-person evaluation, all with a focus on personalized training in core areas contributing to a patient's individual fall risk, much like in-person visits. Virtual home safety surveillance with the mobile virtual platform is an additional feature of this intervention that aims to optimize the home environment to reduce external factors contributing to fall risk. | Other | TELEREHABILITATION ARM |
| Home Safety Evaluation (HSE)The VIRTUAL HOME SAFETY EVALUTIONS (HSE)-ONLY ARM where participants ONLY receive the virtual home safety evaluations and surveillance that are built into the original protocol of three of the four tele-OT visits that is being used in Arm 1. The study duration for Arm 2 is about 6 weeks of the primary intervention as described with 3-month and 6-month follow-up calls. The mobile virtual platform for Arm 2 is comprised of a tablet OR smartphone that will be guided through the home by the care partner only and not the patient. | Other | VIRTUAL HOME SAFETY EVALUATIONS (HSE)-ONLY ARM |
Primary outcome
Adherence Measure - 1:
Time frame: Through study completion of approximately 18 months.
(1) The proportion of scheduled protocol-driven tele-PT and tele-OT visits that were completed.
Adherence Measure - 2:
Time frame: Through study completion of approximately 18 months.
(2) The proportion of scheduled protocol-driven PT/OT exercises/activities that could be completed virtually as assessed by the instructing study therapist.
Adherence Measure - 3:
Time frame: Through study completion of approximately 18 months.
(3) Qualitative categorization of limitations in performing tele-PT and tele-OT visits and PT/OT exercises/activities virtually into patient-related, technology-related, or environmentally-related limitations
Retention Measures:
Time frame: Through study completion of approximately 18 months.
The proportion of patient and care partner (P+CP) pairs that enrolled and were able to complete the study, i.e. study drop-out rate.
Safety Measures:
Time frame: Through study completion of approximately 18 months.
The number and nature of adverse and serious adverse events that occurred due to participation in the study, and the proportion deemed a result of study-related interventions.
13 secondary outcomes
Goals Attainment Scale Score:
Time frame: Through study completion of approximately 18 months.
Falls Diary;
Time frame: Through study completion of approximately 18 months.
Activities-Specific Balance Scale:
Time frame: Through study completion of approximately 18 months.
Five-Times Sit-to-Stand Test:
Time frame: Through study completion of approximately 18 months.
In-Person Objective Therapy Measure - 1:
Time frame: Through study completion of approximately 18 months.
In-Person Objective Therapy Measure - 2:
Time frame: Through study completion of approximately 18 months.
In-Person Objective Therapy Measure - 3:
Time frame: Through study completion of approximately 18 months.
In-Person Objective Therapy Measures - 4:
Time frame: Through study completion of approximately 18 months.
In-Person Objective Therapy Measure - 5:
Time frame: Through study completion of approximately 18 months.
In-Person Objective Therapy Measures - 6:
Time frame: Through study completion of approximately 18 months.
Rapid Turns Test:
Time frame: Through study completion of approximately 18 months.
Parkinson's Disease Questionnaire-39:
Time frame: Through study completion of approximately 18 months.
Home Exercise Program:
Time frame: Through study completion of approximately 18 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 16 Sep 2021.
- Background: PubMed 30003140Marras C, Beck JC, Bower JH, Roberts E, Ritz B, Ross GW, Abbott RD, Savica R, Van Den Eeden SK, Willis AW, Tanner CM; Parkinson's Foundation P4 Group. Prevalence of Parkinson's disease across North America. NPJ Parkinsons Dis. 2018 Jul 10;4:21. doi: 10.1038/s41531-018-0058-0. eCollection 2018.
- Background: PubMed 17377927Macht M, Kaussner Y, Moller JC, Stiasny-Kolster K, Eggert KM, Kruger HP, Ellgring H. Predictors of freezing in Parkinson's disease: a survey of 6,620 patients. Mov Disord. 2007 May 15;22(7):953-6. doi: 10.1002/mds.21458.
- Background: PubMed 15551331Hely MA, Morris JG, Reid WG, Trafficante R. Sydney Multicenter Study of Parkinson's disease: non-L-dopa-responsive problems dominate at 15 years. Mov Disord. 2005 Feb;20(2):190-9. doi: 10.1002/mds.20324.
- Background: PubMed 17131223Poewe W. The natural history of Parkinson's disease. J Neurol. 2006 Dec;253 Suppl 7:VII2-6. doi: 10.1007/s00415-006-7002-7.
- Background: PubMed 25737205Low V, Ben-Shlomo Y, Coward E, Fletcher S, Walker R, Clarke CE. Measuring the burden and mortality of hospitalisation in Parkinson's disease: A cross-sectional analysis of the English Hospital Episodes Statistics database 2009-2013. Parkinsonism Relat Disord. 2015 May;21(5):449-54. doi: 10.1016/j.parkreldis.2015.01.017. Epub 2015 Feb 17.
- Background: PubMed 15580552Wielinski CL, Erickson-Davis C, Wichmann R, Walde-Douglas M, Parashos SA. Falls and injuries resulting from falls among patients with Parkinson's disease and other parkinsonian syndromes. Mov Disord. 2005 Apr;20(4):410-415. doi: 10.1002/mds.20347.
- Background: PubMed 12525724Pressley JC, Louis ED, Tang MX, Cote L, Cohen PD, Glied S, Mayeux R. The impact of comorbid disease and injuries on resource use and expenditures in parkinsonism. Neurology. 2003 Jan 14;60(1):87-93. doi: 10.1212/wnl.60.1.87.
- Derived from this study: PubMed 38213401Afshari M, Hernandez AV, Joyce JM, Hauptschein AW, Trenkle KL, Stebbins GT, Goetz CG. A Novel Home-Based Telerehabilitation Program Targeting Fall Prevention in Parkinson Disease: A Preliminary Trial. Neurol Clin Pract. 2024 Feb;14(1):e200246. doi: 10.1212/CPJ.0000000000200246. Epub 2024 Jan 5.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Mitra Afshari, MD, MPH principal investigator
Rush 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 Physical and occupational therapy (PT/OT) and Home Safety Evaluation (HSE) in people with Parkinson Disease and Telemedicine, run by Rush University Medical Center 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?
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 16 Sep 2021. 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?
Adherence Measure - 1: (time frame: Through study completion of approximately 18 months.). The study lists 5 primary outcomes in all. 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 NCT04600011, which also lists 8 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 16 Sep 2021.