Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease and Parkinsonism; Postural Kyphosis
• Intervention / Treatment: Device: ambulatory use of the Upright device

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:

1. Complete demographic questionnaires and medical history

2. Walking tests and balance:

   1. Short walks at a comfortable speed with or without dual task.
   2. Stairs
   3. 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.
   4. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marina Brozgol; Phone Number: +97236947513; Email: marina.brozgol@gmail.com
• Study Contact Backup: Name: Nir Giladi, MD; Phone Number: +97236947513; Email: nirg@tlvmc.gov.il

Study Locations

• Israel
  • Tel-Aviv, Israel, 64239
    • Recruiting
    • Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
    • Contact: Jefferey Hausdorff; Phone Number: +97236947513; Email: jhausdor@tasmc.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Diagnosis of Parkinson's disease, as defined in the UK Brain Bank criteria
2. Hoehn and Yahr stage I-III
3. Participants who are at stable medication regimen
4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Upright device; Ambulatory use of the Upright device	Device: ambulatory use of the Upright device; Patients will wear the UpRight for a period of two month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average trunk angle in the sagittal plane using a Postural Analysis Chart	Postural Analysis	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction by VAS scores	Results for the VAS scores with possible range 0 (worst) to 10 (best)	8 weeks

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Nir Giladi, MD, TASMC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (ACTUAL): March 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Parkinson Disease; Parkinsonian Disorders; Kyphosis
• Other Study ID Numbers: ASMC-17-NG-0728-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No