Parkinson DiseasePD_managerSINCT03175107
Exergaming in Upper Extremities for Persons With Parkinson's Disease
A study testing Exergaming in people with Parkinson Disease, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial summary
The purpose of the PD_manager project is to explore and develop innovative ecosystem management for people with Parkinson's disease. The research part contains expert analysis of diagnostic tests and decomposition of activity, accompanied by modern IT. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Exergaming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSlovenia
- Study dates
- 2 Nov 2015to 31 Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parkinson disease or Parkinsonism (characteristic symptoms such as rigidity, extrapyramidal symptoms), with functional disorders in upper extremities and minor problems at daily activities;
- Level 2-3 in the Hoehn and Yahr Scale.
Who cannot join
- Any communicable disease;
- Severe vision impairment.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
Official title: mHealth Platform for Parkinson's Disease Management: Exergaming in Upper Extremities for Persons With Parkinson's Disease
The purpose of the PD_manager project is to explore and develop innovative ecosystem management for people with Parkinson's disease. The research part contains expert analysis of diagnostic tests and decomposition of activity, accompanied by modern IT. The results of the analysis will be compared with the results of clinical trials that fall under the routine clinical pathways in monitoring a patient with Parkinson's disease. The primary motor symptoms, such as tremor, bradykinesia and impaired balance, and other symptoms, such as sleep disturbances, speech and cognitive perception, will be assessed by unobtrusive sensors (shoe insoles, bracelets) and sensors embedded in a mobile phone. The collected data will be analyzed using data mining methods and a platform for clinical decision support will be developed. This way, dependency of the patients on other persons will be reduced and the patients' quality of life improved. The patients will be motivated to follow the prescribed diet and take regular medication; the patients' activities will be monitored by occupational therapists and physiotherapists. A technical system will be designed as a computing platform in the open architecture cloud (FI-WARE), which will allow the use of commercially available sensors.
Read the detailed description
The application of tasks in virtual reality and computer games for motoric exercise in patients with neurologic impairment is already quite widespread. It allows controlled workout and flexible gradation of difficulty of the task, which is essential for rehabilitation. Even in patients with Parkinson's disease, it allows for the gradual physiotherapy to improve range of mobility and improve fine motor skills of upper extremities. Within the project, existing games (Microsoft Xbox, Kinect) will be used and a special application for the Microsoft Kinect and Leap Motion systems will be developed, both for the movement of upper extremities as well as fine motor skills (plugs, 9 hole, labyrinth). Both systems will allow data storage, overview of the results, and the algorithm will also adapt the difficulty level of the tasks. This will allow creation of scenarios, as well as monitoring the gradual progress in rehabilitation. The study will begin with treatment in a hospital (URI-Soca), testing three platforms (Kinect, Leap Motion, plate). The most appropriate and most scalable solution will be further developed to the stage where it can be installed in the patient's home. The control of the system and data access will be performed remotely via the Internet and/or mobile phone. When the system is tested and evaluated at the patient's home, a user-friendly application will be developed for the patient to set the desired functions, for the therapist to set difficulty levels and provide instructions to the patient, and for the physician to examine the data and clinically evaluate the patient's condition.
The participants will test the application for up to 4 weeks and then report on the user experience. A standardized questionnaire (NRS 2002) will be used for this purpose. URI-Soca will recruit at least 7 patients, inpatients or outpatients for motor rehabilitation of upper extremities. The tasks will be carried out at the occupational therapy and physiotherapy units of URI-Soca for up to 4 weeks, 3 times a week. At the same time, expert analysis (neurologist, physiotherapist, occupational therapist, engineer) of the measured data (kinematics, the results achieved) will be performed and clinical tests (Unified Parkinson's Disease Rating Scale - UPDRS, Jebsen Tailor Functional Test and PD Questionnaire 39) will be carried out before and after the exercise program. At the same time, the system will be adapted for home use (by at least 1 patient), and then a study will be conducted with other patients. These participants will receive the system for home use for up to 60 days. The data will be accessed remotely over the Internet, so the objective evaluation can be carried out promptly. The clinical test will be conducted before exercise and after exercise, i.e., at the beginning and at the end of the observation period.
- Conditions
- Parkinson Disease
- Being tested
- Exergaming
- Keywords
- exergaming, physiotherapy, upper extremities, telerehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergamingDevice
| Study group | Role | What they receive |
|---|---|---|
| PD_patients | Experimental | Patients with Parkinson disease or Parkinsonism (characteristic symptoms such as rigidity, extrapyramidal symptoms), with functional disorders in upper extremities and minor problems at daily activities, with the level 2-3 in the Hoehn and Yahr Scale. They will perform exergaming at home for up to 4 weeks. Receives: Device: Exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Box & Blocks Test from baseline
Standard clinical test to assesses unilateral gross manual dexterity
Measured: Assessment at baseline and at five weeks
Secondary outcomes (3)
Change in Nine Hole Peg Test from baseline
Standard clinical test for measuring finger dexterity and other aspects of upper extremity function
Measured: Assessment at baseline and at five weeks
Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline
MDS-UPDRS is a comprehensive assessment designed to monitor the burden and extent of Parkinson's disease
Measured: Assessment at baseline and at five weeks
Change in Jebsen Hand Function Test (JHFT) from baseline
JHFT assesses a broad range of uni-manual hand functions required for activities of daily living
Measured: Assessment at baseline and at five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start2 Nov 2015
- Primary completion23 Dec 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Collaborators
- Jozef Stefan Institute
- Responsible party
- Sponsor
- Investigators
- Imre Cikajlo, PhD, Principal investigator, University Rehabilitation Institute, Rehabilitation of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175107
- Sponsor's protocol ID
- URIS201702
- Acronym
- PD_managerSI
- Status last verified
- Apr 2018
- First submitted
- 22 May 2017
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cikajlo I, Hukic A, Zajc D. Exergaming as Part of the Telerehabilitation Can Be Adequate to the Outpatient Training: Preliminary Findings of a Non-randomized Pilot Study in Parkinson's Disease. Front Neurol. 2021 Mar 16;12:625225. doi: 10.3389/fneur.2021.625225. eCollection 2021.
PubMed 33815252
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Platform for Parkinson's Disease Management: Exergaming in Upper Extremities for Persons With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03175107
- Acronym / sponsor ID
- PD_managerSI / URIS201702
- Conditions
- Parkinson Disease
- Keywords
- exergaming, physiotherapy, upper extremities, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Collaborators
- Jozef Stefan Institute
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Jun 2017 (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 the PD_manager project is to explore and develop innovative ecosystem management for people with Parkinson's disease. The research part contains expert analysis of diagnostic tests and decomposition of activity, accompanied by modern IT. The results of the analysis will be compared with the results of clinical trials that fall under the routine clinical pathways in monitoring a patient with Parkinson's disease. The primary motor symptoms, such as tremor, bradykinesia and impaired balance, and other symptoms, such as sleep disturbances, speech and cognitive perception, will be assessed by unobtrusive sensors (shoe insoles, bracelets) and sensors embedded in a mobile phone. The collected data will be analyzed using data mining methods and a platform for clinical decision support will be developed. This way, dependency of the patients on other persons will be reduced and the patients' quality of life improved. The patients will be motivated to follow the prescribed diet and take regular medication; the patients' activities will be monitored by occupational therapists and physiotherapists. A technical system will be designed as a computing platform in the open architecture cloud (FI-WARE), which will allow the use of commercially available sensors.
Detailed description
The application of tasks in virtual reality and computer games for motoric exercise in patients with neurologic impairment is already quite widespread. It allows controlled workout and flexible gradation of difficulty of the task, which is essential for rehabilitation. Even in patients with Parkinson's disease, it allows for the gradual physiotherapy to improve range of mobility and improve fine motor skills of upper extremities. Within the project, existing games (Microsoft Xbox, Kinect) will be used and a special application for the Microsoft Kinect and Leap Motion systems will be developed, both for the movement of upper extremities as well as fine motor skills (plugs, 9 hole, labyrinth). Both systems will allow data storage, overview of the results, and the algorithm will also adapt the difficulty level of the tasks. This will allow creation of scenarios, as well as monitoring the gradual progress in rehabilitation. The study will begin with treatment in a hospital (URI-Soca), testing three platforms (Kinect, Leap Motion, plate). The most appropriate and most scalable solution will be further developed to the stage where it can be installed in the patient's home. The control of the system and data access will be performed remotely via the Internet and/or mobile phone. When the system is tested and evaluated at the patient's home, a user-friendly application will be developed for the patient to set the desired functions, for the therapist to set difficulty levels and provide instructions to the patient, and for the physician to examine the data and clinically evaluate the patient's condition.
The participants will test the application for up to 4 weeks and then report on the user experience. A standardized questionnaire (NRS 2002) will be used for this purpose. URI-Soca will recruit at least 7 patients, inpatients or outpatients for motor rehabilitation of upper extremities. The tasks will be carried out at the occupational therapy and physiotherapy units of URI-Soca for up to 4 weeks, 3 times a week. At the same time, expert analysis (neurologist, physiotherapist, occupational therapist, engineer) of the measured data (kinematics, the results achieved) will be performed and clinical tests (Unified Parkinson's Disease Rating Scale - UPDRS, Jebsen Tailor Functional Test and PD Questionnaire 39) will be carried out before and after the exercise program. At the same time, the system will be adapted for home use (by at least 1 patient), and then a study will be conducted with other patients. These participants will receive the system for home use for up to 60 days. The data will be accessed remotely over the Internet, so the objective evaluation can be carried out promptly. The clinical test will be conducted before exercise and after exercise, i.e., at the beginning and at the end of the observation period.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD_patients | Experimental | Device: ExergamingPatients with Parkinson disease or Parkinsonism (characteristic symptoms such as rigidity, extrapyramidal symptoms), with functional disorders in upper extremities and minor problems at daily activities, with the level 2-3 in the Hoehn and Yahr Scale. They will perform exergaming at home for up to 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson disease or Parkinsonism (characteristic symptoms such as rigidity, extrapyramidal symptoms), with functional disorders in upper extremities and minor problems at daily activities;
- Level 2-3 in the Hoehn and Yahr Scale.
Key exclusion criteria (2 listed)
- Any communicable disease;
- Severe vision impairment.
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 |
|---|---|---|
| Exergaming | Device | PD_patients |
Primary outcome
Change in Box & Blocks Test from baseline
Time frame: Assessment at baseline and at five weeks
Standard clinical test to assesses unilateral gross manual dexterity
3 secondary outcomes
Change in Nine Hole Peg Test from baseline
Time frame: Assessment at baseline and at five weeks
Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline
Time frame: Assessment at baseline and at five weeks
Change in Jebsen Hand Function Test (JHFT) from baseline
Time frame: Assessment at baseline and at five 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 24 Apr 2018.
- Derived from this study: PubMed 33815252Cikajlo I, Hukic A, Zajc D. Exergaming as Part of the Telerehabilitation Can Be Adequate to the Outpatient Training: Preliminary Findings of a Non-randomized Pilot Study in Parkinson's Disease. Front Neurol. 2021 Mar 16;12:625225. doi: 10.3389/fneur.2021.625225. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Imre Cikajlo, PhD principal investigator
University Rehabilitation Institute, Rehabilitation of Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergaming in people with Parkinson Disease, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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 2 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 24 Apr 2018. 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 Slovenia. 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?
Change in Box & Blocks Test from baseline (time frame: Assessment at baseline and at five 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 NCT03175107, which also lists 1 linked publication.
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 24 Apr 2018.