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Exergaming in Upper Extremities for Persons With Parkinson's Disease (PD_managerSI)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Exergaming
Sponsored by
University Rehabilitation Institute, Republic of Slovenia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Parkinson Disease focused on measuring exergaming, physiotherapy, upper extremities, telerehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any communicable disease;
  • Severe vision impairment.

Sites / Locations

  • University Rehabilitation Institute, Republic of Slovenia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD_patients

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Box & Blocks Test from baseline
Standard clinical test to assesses unilateral gross manual dexterity

Secondary Outcome Measures

Change in Nine Hole Peg Test from baseline
Standard clinical test for measuring finger dexterity and other aspects of upper extremity function
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
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

Full Information

First Posted
May 22, 2017
Last Updated
April 23, 2018
Sponsor
University Rehabilitation Institute, Republic of Slovenia
Collaborators
Jozef Stefan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03175107
Brief Title
Exergaming in Upper Extremities for Persons With Parkinson's Disease
Acronym
PD_managerSI
Official Title
mHealth Platform for Parkinson's Disease Management: Exergaming in Upper Extremities for Persons With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2, 2015 (Actual)
Primary Completion Date
December 23, 2016 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Rehabilitation Institute, Republic of Slovenia
Collaborators
Jozef Stefan Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
exergaming, physiotherapy, upper extremities, telerehabilitation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD_patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Exergaming
Primary Outcome Measure Information:
Title
Change in Box & Blocks Test from baseline
Description
Standard clinical test to assesses unilateral gross manual dexterity
Time Frame
Assessment at baseline and at five weeks
Secondary Outcome Measure Information:
Title
Change in Nine Hole Peg Test from baseline
Description
Standard clinical test for measuring finger dexterity and other aspects of upper extremity function
Time Frame
Assessment at baseline and at five weeks
Title
Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline
Description
MDS-UPDRS is a comprehensive assessment designed to monitor the burden and extent of Parkinson's disease
Time Frame
Assessment at baseline and at five weeks
Title
Change in Jebsen Hand Function Test (JHFT) from baseline
Description
JHFT assesses a broad range of uni-manual hand functions required for activities of daily living
Time Frame
Assessment at baseline and at five weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Any communicable disease; Severe vision impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imre Cikajlo, PhD
Organizational Affiliation
University Rehabilitation Institute, Rehabilitation of Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Rehabilitation Institute, Republic of Slovenia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33815252
Citation
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.
Results Reference
derived

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Exergaming in Upper Extremities for Persons With Parkinson's Disease

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