Clinical trial NCT03477695: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease and Parkinsonism
Postural Kyphosis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average trunk angle in the sagittal plane using a Postural Analysis Chart
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient satisfaction by VAS scores
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: TASMC
name: Nir Giladi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.