NCT03175107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

May 22, 2017

Last Update Submit

April 23, 2018

Conditions

Parkinson Disease

Keywords

exergamingphysiotherapyupper extremitiestelerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in Box & Blocks Test from baseline

    Standard clinical test to assesses unilateral gross manual dexterity

    Assessment at baseline and at five weeks

Secondary Outcomes (3)

  • Change in Nine Hole Peg Test from baseline

    Assessment at baseline and at five weeks

  • Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline

    Assessment at baseline and at five weeks

  • Change in Jebsen Hand Function Test (JHFT) from baseline

    Assessment at baseline and at five weeks

Study Arms (1)

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.

Device: Exergaming

Interventions

ExergamingDEVICE
PD_patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any communicable disease;
  • Severe vision impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 33815252DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Imre Cikajlo, PhD

    University Rehabilitation Institute, Rehabilitation of Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

June 5, 2017

Study Start

November 2, 2015

Primary Completion

December 23, 2016

Study Completion

December 31, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

SL(1)