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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
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.
- Conditions
- Gait, Parkinson Disease
- 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 group | Role | What they receive |
|---|---|---|
| Feedforward stimulation | Experimental | Prior to any gait condition likely to invoke freez, auditory stimulation is presented Receives: Behavioral: Biofeedback-based motor learning for PD |
| Feedback stimulation | Experimental | Once 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.
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)
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.
- First posted19 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionMay 2012 (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 GaitStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback-based Motor Learning to Ameliorate Freezing of Gait
- ClinicalTrials.gov ID
- NCT01223781
- Acronym / sponsor ID
- 510-10-TLV
- Conditions
- Gait, Parkinson Disease
- Keywords
- Freezing, biofeedback, motor learning, freezing of gait in PD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 19 Oct 2010 (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.
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedforward stimulation | Experimental | Behavioral: Biofeedback-based motor learning for PDPrior to any gait condition likely to invoke freez, auditory stimulation is presented |
| Feedback stimulation | Experimental | Behavioral: Biofeedback-based motor learning for PDOnce a device identifies freezing, a auditory stimulation is triggered |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1) Unable to walk unassisted for at least 5 minutes with ample rest. 2)Brain surgery.
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 |
|---|---|---|
| Biofeedback-based motor learning for PDPrior to freezing episodes, auditory stimulation is triggered | Behavioural | Feedback stimulation, Feedforward stimulation |
Primary outcome
Number of freezing episodes
Time frame: 3 days
In lab examinaiton and then in 3 days of ambulatory monitoring, the nubmer of freezing episodes will be counted before and after the intervention.
1 secondary outcome
duration of freezing episodes
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
- Background: PubMed 19906597Bachlin 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.
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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.
1 site in 1 country: see every site and its status.
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.