Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback
Primary Purpose
Parkinson's Disease and Parkinsonism, Postural Kyphosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ambulatory use of the Upright device
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease and Parkinsonism
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
1. Mini Mental State Exam (MMSE) score< 24
Sites / Locations
- Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Upright device
Arm Description
Ambulatory use of the Upright device
Outcomes
Primary Outcome Measures
Average trunk angle in the sagittal plane using a Postural Analysis Chart
Postural Analysis
Secondary Outcome Measures
Patient satisfaction by VAS scores
Results for the VAS scores with possible range 0 (worst) to 10 (best)
Full Information
NCT ID
NCT03477695
First Posted
March 20, 2018
Last Updated
May 6, 2018
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03477695
Brief Title
Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback
Official Title
Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The subjects will be asked to arrive at the Gait laboratory for Mobility Research at Tel Aviv Medical Center. After a detailed explanation of the research procedure and after signing the consent form, they will be introduced to the UPRIGHT GO device. Participances will practice operating and placing the device on the body.
With the device attached to upper back, a number of short clinical tests will be performed:
Complete demographic questionnaires and medical history
Walking tests and balance:
Short walks at a comfortable speed with or without dual task.
Stairs
Performing daily tasks, such as entering and exiting a room, negotiating obstacles (shoebox), walking between obstacles, buttons, tying laces, carrying small objects on a tray, bringing a glass of water etc.
Timed "Get up and go test" All tests are supervised by a physiotherapist .
Upon completion of the tests, the UPRIGHT device will be delivered for use and exercise for 2 months. Physiotherapist will guide to maintain the devices (such as charging devices and connecting to power).
At the end of the training period, the participans will be invited again to Gait Lab for post tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease and Parkinsonism, Postural Kyphosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Upright device
Arm Type
Experimental
Arm Description
Ambulatory use of the Upright device
Intervention Type
Device
Intervention Name(s)
ambulatory use of the Upright device
Intervention Description
Patients will wear the UpRight for a period of two month
Primary Outcome Measure Information:
Title
Average trunk angle in the sagittal plane using a Postural Analysis Chart
Description
Postural Analysis
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Patient satisfaction by VAS scores
Description
Results for the VAS scores with possible range 0 (worst) to 10 (best)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
1. Mini Mental State Exam (MMSE) score< 24
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Brozgol
Phone
+97236947513
Email
marina.brozgol@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nir Giladi, MD
Phone
+97236947513
Email
nirg@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nir Giladi, MD
Organizational Affiliation
TASMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jefferey Hausdorff
Phone
+97236947513
Email
jhausdor@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Jeffrey M Hausdorff, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
28802759
Citation
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.
Results Reference
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Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback
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