Parkinson's Disease PatientsNCT00716261
Bio-Feedback to Improving Stability in Elderly Population
A study testing McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes in people with Parkinson's Disease Patients, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Our hypothesis is that intensive training with positive biofeedback may enhance postural control and stability in Parkinson's disease patients and in elderly fallers. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Parkinson's Disease Patients
- What is being tested?
- McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Nov 2009
- 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
- Idiopathic PD for >2 yrs
- Between 50-90 Yrs
- On anti-Parkinsonian medication
- Hoehn \& Yahr 2-3 in "ON"
- Free of serious co-morbidities
- Able to walk but reports difficulties in gait
- Can use assistive device
Who cannot join
- Significant orthopedic disturbances or pain
- Major depression (DSM IV)
- Dementia (MMSE<24)
- Clinically significant hearing problems
- Unstable medical condition (2 wks from meds change)
- Deep Brain Stimulation
Trial locations and contacts
1 site in 1 country.
Israel1 site
Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: Using Bio-Feedback for Improving Stability in Walking and Everyday Activity
Our hypothesis is that intensive training with positive biofeedback may enhance postural control and stability in Parkinson's disease patients and in elderly fallers.
Read the detailed description
The aim of the study is to treat Parkinson's patients and elderly fallers. The intervention is intensive training with Biofeedback to try to correct stooped posture, and to improve stability in standing and in walking.
- Conditions
- Parkinson's Disease Patients
- Being tested
- McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes
- Keywords
- Parkinson's disease, Audio feedback, postural control
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopesDevice
Also called AUDIO-BIOFEEDBACK SYSTEM, DEIS, Università di Bologna, Bologna, Italy(Chiari et al., 2005)
Training with the Audio-feedback device for about 30 minutes, 3 times per week for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease PatientsStudies 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
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Jeffrey M Hausdorff, PhD, Principal investigator, Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716261
- Sponsor's protocol ID
- 0204-08-TLV
- Status last verified
- Jul 2008
- First submitted
- 14 Jul 2008
- Last updated
- 16 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Bio-Feedback for Improving Stability in Walking and Everyday Activity
- ClinicalTrials.gov ID
- NCT00716261
- Acronym / sponsor ID
- 0204-08-TLV
- Conditions
- Parkinson's Disease Patients
- Keywords
- Parkinson's disease, Audio feedback, postural control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 16 Jul 2008 (estimated)
- 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.
Our hypothesis is that intensive training with positive biofeedback may enhance postural control and stability in Parkinson's disease patients and in elderly fallers.
Detailed description
The aim of the study is to treat Parkinson's patients and elderly fallers. The intervention is intensive training with Biofeedback to try to correct stooped posture, and to improve stability in standing and in walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Idiopathic PD for >2 yrs
- Between 50-90 Yrs
- On anti-Parkinsonian medication
- Hoehn \& Yahr 2-3 in "ON"
- Free of serious co-morbidities
Key exclusion criteria (6 listed)
- Significant orthopedic disturbances or pain
- Major depression (DSM IV)
- Dementia (MMSE<24)
- Clinically significant hearing problems
- Unstable medical condition (2 wks from meds change)
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 |
|---|---|---|
| McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopesAlso: AUDIO-BIOFEEDBACK SYSTEM, DEIS, Università di Bologna, Bologna, Italy(Chiari et al., 2005)Training with the Audio-feedback device for about 30 minutes, 3 times per week for 6 weeks | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2008.
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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.
Jeffrey M Hausdorff, PhD principal investigator
Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes in people with Parkinson's Disease Patients, 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 7 inclusion and 6 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 16 Jul 2008. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 16 Jul 2008.