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Status unknownNCT03477695Updated May 8, 2018

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

An interventional study of ambulatory use of the Upright device in Parkinson's Disease and Parkinsonism and Postural Kyphosis, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-05-08.

Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
50 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 24 studies in Parkinson Disease by Tel-Aviv Sourasky Medical Center — 4 open to participants now, 4 under way, none of them phase 3. Parkinson Disease · Tel-Aviv Sourasky Medical Center.

Planned enrollment
5th of 14
60 · median 50
Started
2018
with 1 other
No phase
13 of 24
3 open now
Registered
18th of 24
by date

Among the 24 studies in Parkinson Disease by Tel-Aviv Sourasky Medical Center, this one is the 5th largest by planned enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2018, is one of 13 with no phase, and was the 18th registered.

Parkinson Disease

4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

4 of the 24 studies in Parkinson Disease by Tel-Aviv Sourasky Medical Center are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Israel3

All 4 open studies →

Who these studies take

Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.

This study: 50 Years to 90 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Parkinson's Disease and Parkinsonism
  • Postural Kyphosis
04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  1. (MMSE) score\< 24
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Upright device

    Ambulatory use of the Upright device

    Device: ambulatory use of the Upright device

Interventions

  • Deviceambulatory use of the Upright device

    Patients will wear the UpRight for a period of two month

06

What researchers measure

Primary outcomes

  1. Average trunk angle in the sagittal plane using a Postural Analysis Chart

    Postural Analysis

    Time frame: 8 weeks

Secondary outcomes

  1. Patient satisfaction by VAS scores

    Results for the VAS scores with possible range 0 (worst) to 10 (best)

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
    Tel-Aviv, 64239, Israel
    Recruiting
08

References and documents

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. PubMed 28802759 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2018 (actual). Primary completion is estimated for Dec 2019, 20 months after the start.

Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 20 months is below that.

Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2018
First posted
Mar 26, 2018
StartActual
Apr 1, 2018
Primary completionEst.
Dec 31, 2019
CompletionEst.
Dec 31, 2019
Last update
May 8, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477695
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
Mar 26, 2018
Start date
Apr 1, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
May 8, 2018

Study contacts

Marina Brozgol
Contact
marina.brozgol@gmail.com
+97236947513
Nir Giladi, MD
Contact
nirg@tlvmc.gov.il
+97236947513
Nir Giladi, MD
principal investigator · TASMC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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