Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback
1 other identifier
interventional
60
1 country
1
Brief Summary
A stooped posture is one of the characteristic motor symptoms of patients with Parkinson's disease, and has been linked to impairments in ADL and QOL. We aimed to test the efficacy, safety, practical utility and user-friendliness of a posture correction and vibrotactile trunk angle feedback device (the UpRight) in the home setting of patients with Parkinson's disease with a stooped posture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
March 26, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMay 8, 2018
March 1, 2018
1.8 years
March 20, 2018
May 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Average trunk angle in the sagittal plane using a Postural Analysis Chart
Postural Analysis
8 weeks
Secondary Outcomes (1)
Patient satisfaction by VAS scores
8 weeks
Study Arms (1)
Upright device
EXPERIMENTALAmbulatory use of the Upright device
Interventions
Patients will wear the UpRight for a period of two month
Eligibility Criteria
You may qualify if:
- Diagnosis of Parkinson's disease, as defined in the UK Brain Bank criteria
- Hoehn and Yahr stage I-III
- Participants who are at stable medication regimen
- Able to walk independently for at least 5 minutes with or without support of accessory device.
You may not qualify if:
- \. Mini Mental State Exam (MMSE) score\< 24
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Related Publications (1)
van Wegen EEH, de Goede CJT, Kwakkel G, van Kordelaar J. Sensor assisted self-management in Parkinson's disease: A feasibility study of ambulatory posture detection and feedback to treat stooped posture. Parkinsonism Relat Disord. 2018 Jan;46 Suppl 1:S57-S61. doi: 10.1016/j.parkreldis.2017.07.024. Epub 2017 Jul 25.
PMID: 28802759BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nir Giladi, MD
TASMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2018
First Posted
March 26, 2018
Study Start
April 1, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
May 8, 2018
Record last verified: 2018-03