Parkinson's Disease and ParkinsonismNCT03477695
Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback
A study testing ambulatory use of the Upright device in people with Parkinson's Disease and Parkinsonism and Postural Kyphosis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Parkinson's Disease and Parkinsonism, Postural Kyphosis
- What is being tested?
- ambulatory use of the Upright device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Mini Mental State Exam (MMSE) score< 24
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Jefferey Hausdorff, +97236947513, jhausdor@tasmc.health.gov.il
Jeffrey M Hausdorff, PhD
About this study
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:
- 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.
- Being tested
- ambulatory use of the Upright device
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ambulatory use of the Upright deviceDevice
Patients will wear the UpRight for a period of two month
| Study group | Role | What they receive |
|---|---|---|
| Upright device | Experimental | Ambulatory use of the Upright device Receives: Device: ambulatory use of the Upright device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average trunk angle in the sagittal plane using a Postural Analysis Chart
Postural Analysis
Measured: 8 weeks
Secondary outcomes (1)
Patient satisfaction by VAS scores
Results for the VAS scores with possible range 0 (worst) to 10 (best)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease and ParkinsonismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nir Giladi, MD, Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477695
- Sponsor's protocol ID
- ASMC-17-NG-0728-CTIL
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback
- ClinicalTrials.gov ID
- NCT03477695
- Acronym / sponsor ID
- ASMC-17-NG-0728-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upright device | Experimental | Device: ambulatory use of the Upright deviceAmbulatory use of the Upright device |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Mini Mental State Exam (MMSE) score< 24
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ambulatory use of the Upright devicePatients will wear the UpRight for a period of two month | Device | Upright device |
Primary outcome
Average trunk angle in the sagittal plane using a Postural Analysis Chart
Time frame: 8 weeks
Postural Analysis
1 secondary outcome
Patient satisfaction by VAS scores
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Background: PubMed 28802759van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Giladi, MD principal investigator
TASMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ambulatory use of the Upright device in people with Parkinson's Disease and Parkinsonism and Postural Kyphosis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Brozgol (+97236947513, marina.brozgol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average trunk angle in the sagittal plane using a Postural Analysis Chart (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03477695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.