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GaitNCT01223781

Biofeedback-based Motor Learning to Ameliorate Freezing of Gait

A study testing Biofeedback-based motor learning for PD in people with Gait and Parkinson Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective/Rationale: The investigators objective is to demonstrate that an intervention program based on motor learning principles can be applied to train subjects with Parkinson's disease (PD) who suffer from freezing to walk in a way that minimizes the occurrence of freezing. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Gait, Parkinson Disease
What is being tested?
Biofeedback-based motor learning for PD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIsrael
Study dates
Jan 2011to May 2012
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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 1) Unable to walk unassisted for at least 5 minutes with ample rest. 2)Brain surgery.

Trial locations and contacts

1 site in 1 country.

Jeffrey M Hausdorff, PhD contact

972 326974958

jhausdor@tasmc.health.gov.il

Israel1 site
  • Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Meir Plotnik, PhD, +972-3-6974958, meirp@tasmc.health.gov.il

    Meir Plotnik, PhD

Other trials in Israel

About this study

Objective/Rationale:

The investigators objective is to demonstrate that an intervention program based on motor learning principles can be applied to train subjects with Parkinson's disease (PD) who suffer from freezing to walk in a way that minimizes the occurrence of freezing. Since sufficient motor learning capabilities are preserved in PD, the investigators hypothesize that an intervention program that targets the time periods just prior to an approaching freezing episode can modify the walking strategies so that the episode will now be averted.

Read more

Project Description:

The freezing burden will be quantified in subjects with PD before and after 6 weeks of training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking courses aimed at provoking freezing episodes. The experimenter will trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid freezing. Similar principles will apply for the CLG training; however, the RAS will be elicited automatically by a device that recognizes an approaching freezing episode.

Relevance to Diagnosis/Treatment of Parkinson's Disease:

If even partially successful, the investigators will show, for the first time that freezing of gait is amenable to motor learning and that appropriate training with external cueing can alleviate these motor blockades. While future studies will be needed to further assess long-term efficacy and other important questions about clinical efficacy and the mechanisms involved, this study should go a long way towards improving the investigators understanding of freezing of gait and its amenability to appropriate therapy.

Anticipated Outcome:

The investigators anticipate that after intensive training, the central nervous system (CNS) of subjects with PD will be able to anticipate impending freezing episodes based on awareness of the environmental conditions (e.g., an approaching turn) and/or based on sub-conscious response to a deteriorating gait pattern. As a result, an automated motor response that paces and coordinates gait will be internally triggered by the CNS and the approaching freezing episode will be averted. The overall freezing burden will therefore decrease in trained subjects.

Read the detailed description

Overview: This will be a randomized trial to demonstrate the effects of 6-weeks of training with open-loop or triggered, closed-loop cueing. PD+ FOG patients will be studied before and after 6 weeks of training (total of 18 sessions) and one month later (to begin to assess retention). The two intervention groups will receive training sessions designed to enhance implicit motor learning and avoidance of FOG. This will be the first study to assess these novel paradigms. If the results support the hypotheses, further studies will be needed including a placebo-controlled trial. 20 subjects will be included in the feed-forward, open-loop group (OLG) and 20 in the feedback, closed-loop group (CLG) (based on power analysis to provide 80% power at α=0.05). Participants will be recruited on a rolling admission basis (about 2 subjects per week over ~20 weeks) and will be randomly assigned to one of the 2 groups. Pre, post and retention effects will be tested without knowledge of group assignment. A (repeated measures) mixed models statistical approach will be used to evaluate within and across group effects over time, adjusting for baseline values. The study will be conducted under the auspices of the Laboratory for Gait and Neurodynamics and the Movement Disorders Unit (MDU) at the Tel-Aviv Sourasky Medical Center. At all times during training and testing, the subjects will be closely monitored by a research assistant to ensure safety.

Being tested
Biofeedback-based motor learning for PD
Keywords
Freezing, biofeedback, motor learning, freezing of gait in PD
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biofeedback-based motor learning for PDBehavioural

    Prior to freezing episodes, auditory stimulation is triggered

Study groups in NCT01223781
Study groupRoleWhat they receive
Feedforward stimulationExperimentalPrior to any gait condition likely to invoke freez, auditory stimulation is presented
Receives: Behavioral: Biofeedback-based motor learning for PD
Feedback stimulationExperimentalOnce a device identifies freezing, a auditory stimulation is triggered
Receives: Behavioral: Biofeedback-based motor learning for PD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of freezing episodes

    In lab examinaiton and then in 3 days of ambulatory monitoring, the nubmer of freezing episodes will be counted before and after the intervention.

    Measured: 3 days

Secondary outcomes (1)
  1. duration of freezing episodes

    In lab examinaiton and then in 3 days of ambulatory monitoring, the duration of freezing episodes will be counted before and after the intervention

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2012 (estimated)
  4. Study completionMay 2012 (estimated)

Resources

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
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01223781
Sponsor's protocol ID
510-10-TLV
Status last verified
Oct 2010
First submitted
17 Oct 2010
Last updated
19 Oct 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Bachlin M, Plotnik M, Roggen D, Maidan I, Hausdorff JM, Giladi N, Troster G. Wearable assistant for Parkinson's disease patients with the freezing of gait symptom. IEEE Trans Inf Technol Biomed. 2010 Mar;14(2):436-46. doi: 10.1109/TITB.2009.2036165. Epub 2009 Nov 10.

    PubMed 19906597

Questions about this trial

What is this clinical trial studying?

A study testing Biofeedback-based motor learning for PD in people with Gait and Parkinson Disease, 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 0 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 19 Oct 2010. 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 Meir Plotnik, PhD (972 326974958, meirp@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of freezing episodes (time frame: 3 days). 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 NCT01223781, 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 19 Oct 2010.

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