Parkinson DiseaseNCT06306768
Remote Therapeutic Monitoring Exercise Tracking
A study testing Activity Monitoring in people with Parkinson Disease and Multiple Sclerosis, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Parkinson Disease, Multiple Sclerosis
- What is being tested?
- Activity Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are ambulatory as their primary means of mobility without an assistive device except for single point cane or walking sticks in community
- Have a diagnosis of Parkinson's disease (Hoehn and Yahr 1-3), Parkinsonism, or Multiple Sclerosis
- Personal goal and willingness to address physical activity
- Have a smart phone (Datos Health app is compatible with any Smart phone device)
- Willing to accept Datos' Terms and Conditions
Who cannot join
- Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.
The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform.
Read the detailed description
Remote therapeutic monitoring (RTM) is a reimbursable clinical service. Pilot investigation conducted by our lab demonstrated promise that this service is feasible to add to clinical care. It is unclear still if RTM is able to provide clinical benefit to patients including improving and sustaining physical activity (PA) and exercise behaviors over a longer period of time (>1 year). Our central hypothesis is that the addition of RTM to physical activity, both in a skilled rehabilitation program and within a home program, will improve long term outcomes related to physical activity including self-efficacy for exercise, consistent participation in home exercise recommendations, and quality of life in people living with PD and MS. Thus the specific aims of this study are as follows:
- To assess PA and exercise behaviors over 1-year period using a remote therapeutic monitoring platform
- We will track steps per day, minutes of aerobic activity per week, and frequency of workouts including flexibility, balance, and resistance training.
- To understand how engagement with RTM for PA tracking affects overall self-efficacy for exercise, readiness for exercise behavior change, and quality of life.
- Assessed through monthly self-report of usability survey for RTM and self-efficacy for exercise survey.
- Conditions
- Parkinson Disease, Multiple Sclerosis
- Being tested
- Activity Monitoring
- Keywords
- physical activity, exercise tracking, remote therapeutic monitoring, quality of life, self-efficacy
- Medical subject headings
- Parkinson Disease, Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity MonitoringDevice
Also called Datos Health App
Tracking participants step activity, workout frequency, minutes in target heart rate zone, and type of exercises completed over 1 year period. Goals will be set and customized by a research physical therapist to participants based on best practice recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Remote Therapeutic Monitoring | Other | Participants will receive 1 year of remote therapeutic monitoring via a connected health app and personal activity tracker to monitor their physical activity and exercise behaviors. Receives: Device: Activity Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Metric 1
steps per day
Measured: Daily, through study completion, average 1 year
Physical Activity Metric 2
Minutes of aerobic physical activity per day (moderate to vigorous physical activity)
Measured: Daily, through study completion, average 1 year
Secondary outcomes (3)
Exercise Self Efficacy
sums of 9 items with total scores ranging from 0-90; higher scores indicating higher self-efficacy.
Measured: Completed every other month, through study completion, average of 1 year
Quality of Life from PROMIS 10-b
PROMIS 10-b short form which is 10 items measuring mobility difficulty, scores are summed and then translated to t-score.
Measured: Completed every 3 months, through study completion, average of 1 year
Quality of Life from PROMIS-29
PROMIS-29 measures seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and sleep disturbance).
Measured: Completed every 3 months, through study completion, average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Apr 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Shirley Ryan AbilityLabThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Rafferty, Shirley Ryan AbilityLab
- Investigators
- Miriam Rafferty, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306768
- Sponsor's protocol ID
- STU00219979
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Block VA, Pitsch E, Tahir P, Cree BA, Allen DD, Gelfand JM. Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. PLoS One. 2016 Apr 28;11(4):e0154335. doi: 10.1371/journal.pone.0154335. eCollection 2016.
PubMed 27124611Proschinger S, Kuhwand P, Rademacher A, Walzik D, Warnke C, Zimmer P, Joisten N. Fitness, physical activity, and exercise in multiple sclerosis: a systematic review on current evidence for interactions with disease activity and progression. J Neurol. 2022 Jun;269(6):2922-2940. doi: 10.1007/s00415-021-10935-6. Epub 2022 Jan 27.
PubMed 35084560Speelman AD, van de Warrenburg BP, van Nimwegen M, Petzinger GM, Munneke M, Bloem BR. How might physical activity benefit patients with Parkinson disease? Nat Rev Neurol. 2011 Jul 12;7(9):528-34. doi: 10.1038/nrneurol.2011.107.
PubMed 21750523
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT06306768
- Acronym / sponsor ID
- STU00219979
- Conditions
- Parkinson Disease, Multiple Sclerosis
- Keywords
- physical activity, exercise tracking, remote therapeutic monitoring, quality of life, self-efficacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 12 Mar 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 purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform.
Detailed description
Remote therapeutic monitoring (RTM) is a reimbursable clinical service. Pilot investigation conducted by our lab demonstrated promise that this service is feasible to add to clinical care. It is unclear still if RTM is able to provide clinical benefit to patients including improving and sustaining physical activity (PA) and exercise behaviors over a longer period of time (>1 year). Our central hypothesis is that the addition of RTM to physical activity, both in a skilled rehabilitation program and within a home program, will improve long term outcomes related to physical activity including self-efficacy for exercise, consistent participation in home exercise recommendations, and quality of life in people living with PD and MS. Thus the specific aims of this study are as follows:
- To assess PA and exercise behaviors over 1-year period using a remote therapeutic monitoring platform
- We will track steps per day, minutes of aerobic activity per week, and frequency of workouts including flexibility, balance, and resistance training.
- To understand how engagement with RTM for PA tracking affects overall self-efficacy for exercise, readiness for exercise behavior change, and quality of life.
- Assessed through monthly self-report of usability survey for RTM and self-efficacy for exercise survey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Therapeutic Monitoring | Other | Device: Activity MonitoringParticipants will receive 1 year of remote therapeutic monitoring via a connected health app and personal activity tracker to monitor their physical activity and exercise behaviors. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are ambulatory as their primary means of mobility without an assistive device except for single point cane or walking sticks in community
- Have a diagnosis of Parkinson's disease (Hoehn and Yahr 1-3), Parkinsonism, or Multiple Sclerosis
- Personal goal and willingness to address physical activity
- Have a smart phone (Datos Health app is compatible with any Smart phone device)
- Willing to accept Datos' Terms and Conditions
Key exclusion criteria (1 listed)
- Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM
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 |
|---|---|---|
| Activity MonitoringAlso: Datos Health AppTracking participants step activity, workout frequency, minutes in target heart rate zone, and type of exercises completed over 1 year period. Goals will be set and customized by a research physical therapist to participants based on best practice recommendations. | Device | Remote Therapeutic Monitoring |
Primary outcome
Physical Activity Metric 1
Time frame: Daily, through study completion, average 1 year
steps per day
Physical Activity Metric 2
Time frame: Daily, through study completion, average 1 year
Minutes of aerobic physical activity per day (moderate to vigorous physical activity)
3 secondary outcomes
Exercise Self Efficacy
Time frame: Completed every other month, through study completion, average of 1 year
Quality of Life from PROMIS 10-b
Time frame: Completed every 3 months, through study completion, average of 1 year
Quality of Life from PROMIS-29
Time frame: Completed every 3 months, through study completion, average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 27124611Block VA, Pitsch E, Tahir P, Cree BA, Allen DD, Gelfand JM. Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. PLoS One. 2016 Apr 28;11(4):e0154335. doi: 10.1371/journal.pone.0154335. eCollection 2016.
- Background: PubMed 35084560Proschinger S, Kuhwand P, Rademacher A, Walzik D, Warnke C, Zimmer P, Joisten N. Fitness, physical activity, and exercise in multiple sclerosis: a systematic review on current evidence for interactions with disease activity and progression. J Neurol. 2022 Jun;269(6):2922-2940. doi: 10.1007/s00415-021-10935-6. Epub 2022 Jan 27.
- Background: PubMed 21750523Speelman AD, van de Warrenburg BP, van Nimwegen M, Petzinger GM, Munneke M, Bloem BR. How might physical activity benefit patients with Parkinson disease? Nat Rev Neurol. 2011 Jul 12;7(9):528-34. doi: 10.1038/nrneurol.2011.107.
- 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.
Miriam Rafferty, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Monitoring in people with Parkinson Disease and Multiple Sclerosis, run by Shirley Ryan AbilityLab 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Physical Activity Metric 1 (time frame: Daily, through study completion, average 1 year). The study lists 2 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 NCT06306768, which also lists 3 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 20 Apr 2026.