Parkinson's DiseaseNCT03406754
Multi-disciplinary Rehabilitation Program for Advanced Parkinson's Patients in the Community
An observational study of Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
Trial summary
The present study examines the effectiveness of the rehabilitation program in the framework of the "Ezra LeMarpeh" project for Parkinson's patients. The Ezra LeMarpeh Association, founded by Rabbi A. E. Firer, provides assistance to the sick and needy. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- rehabilitation programs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Feb 2018to Dec 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with parkinson's disease participated in rehabilitation program
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease, as defined in the UK Brain Bank criteria
- Hoehn and Yahr stage I-III
- Patients who are taking anti-Parkinson's drugs.
- Participants who are in a stable medication regimen during the month preceding the study and are expected to remain in a permanent regime for the next 3 months.
- Mini Mental State Exam (MMSE) score> 24
- Able to walk independently for at least 5 minutes with or without support.
Who cannot join
- Any neurological condition other than PD or orthopedic disease (eg after a stroke with neurological signs, MSA, Parkinsonism, PSP, etc.) that may impair normal walking and balance.
- Significant cognitive impairment MMSE score<24
- Any medical, surgical, and / or psychiatric condition which, in the opinion of the investigator, prevents the patient from completing all aspects of the research.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
The present study examines the effectiveness of the rehabilitation program in the framework of the "Ezra LeMarpeh" project for Parkinson's patients. The Ezra LeMarpeh Association, founded by Rabbi A. E. Firer, provides assistance to the sick and needy. The site features a wide range of advanced, high quality rehabilitation devices, a unique hydrotherapy pool and associated accessories that enable the staff to provide the finest quality and most professional treatment. Before entering a rehabilitative program, each participant will arrive independently at the Ezra LeMarpeh Center for evaluation tests and will undergo comprehensive evaluation tests by the center's physiotherapist, including walking tests, balance tests, filling out questionnaires to assess Quality of life and disease severity. At the end of the program, the participants will be asked to repeat evaluation tests.
Read the detailed description
Before entering a rehabilitation program, each participant will arrive independently at the "Ezra LeMarpeh" Center, at 24 Chida St., Bnei Brak. After a detailed explanation of the nature of the study, the participants will sign an informed consent form. The center's physiotherapists will test walking abilities, motor functioning and abilities in activities of daily living (ADL).
Walking tests can include walking at a comfortable pace, walking while counting (dual tasking), walking at different speeds and more. The balance tests include standing on a small base, standing on one leg, standing with eyes closed, and more. During the tests participants will wear small, non-invasive sensors at the wrists, ankles, and lower back. These sensors include an accelerometers and a gyroscopes that can be used to quantify gait measures, such as gait velocity, step length and variability. Lower back sensors will be worn continuously for up to a week for everyday activity.
At the end of the program, the participants will be asked to repeat evaluation tests.
- Conditions
- Parkinson's Disease
- Being tested
- rehabilitation programs
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation programsBehavioural
an 8-week multidisciplinary inpatient rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Ezera LaMarpeh rehabilitation programs | Participation in a rehabilitation program for 8 weeks Receives: Behavioral: rehabilitation programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate change in gait speed
Gait speed will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
Measured: Immediate at the end of the program (8 weeks)
Community ambulation
Will be assessed using a body-worn small lightweight device (AX3 - continuous logging accelerometer) that will be worn by the subjects for 7 days to monitor ADL.
Measured: Immediate at the end of the program (8 weeks)
Secondary outcomes (2)
Improve in motor function
Timed Up \& Go scores
Measured: Immediate at the end of the program (8 weeks)
Motor function
UPDRS III scores
Measured: Immediate at the end of the program (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tanya Gurevich, MD, Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406754
- Sponsor's protocol ID
- TASMC-17-TG-0745-CTIL
- Status last verified
- Mar 2020
- First submitted
- 7 Jan 2018
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-disciplinary Rehabilitation Program for Advanced Parkinson's Patients in the Community
- ClinicalTrials.gov ID
- NCT03406754
- Acronym / sponsor ID
- TASMC-17-TG-0745-CTIL
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Jan 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.
The present study examines the effectiveness of the rehabilitation program in the framework of the "Ezra LeMarpeh" project for Parkinson's patients. The Ezra LeMarpeh Association, founded by Rabbi A. E. Firer, provides assistance to the sick and needy. The site features a wide range of advanced, high quality rehabilitation devices, a unique hydrotherapy pool and associated accessories that enable the staff to provide the finest quality and most professional treatment. Before entering a rehabilitative program, each participant will arrive independently at the Ezra LeMarpeh Center for evaluation tests and will undergo comprehensive evaluation tests by the center's physiotherapist, including walking tests, balance tests, filling out questionnaires to assess Quality of life and disease severity. At the end of the program, the participants will be asked to repeat evaluation tests.
Detailed description
Before entering a rehabilitation program, each participant will arrive independently at the "Ezra LeMarpeh" Center, at 24 Chida St., Bnei Brak. After a detailed explanation of the nature of the study, the participants will sign an informed consent form. The center's physiotherapists will test walking abilities, motor functioning and abilities in activities of daily living (ADL).
Walking tests can include walking at a comfortable pace, walking while counting (dual tasking), walking at different speeds and more. The balance tests include standing on a small base, standing on one leg, standing with eyes closed, and more. During the tests participants will wear small, non-invasive sensors at the wrists, ankles, and lower back. These sensors include an accelerometers and a gyroscopes that can be used to quantify gait measures, such as gait velocity, step length and variability. Lower back sensors will be worn continuously for up to a week for everyday activity.
At the end of the program, the participants will be asked to repeat evaluation tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ezera LaMarpeh rehabilitation programs | – | Behavioral: rehabilitation programsParticipation in a rehabilitation program for 8 weeks |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with parkinson's disease participated in rehabilitation program
Key inclusion criteria (6 listed)
- Diagnosis of idiopathic Parkinson's disease, as defined in the UK Brain Bank criteria
- Hoehn and Yahr stage I-III
- Patients who are taking anti-Parkinson's drugs.
- Participants who are in a stable medication regimen during the month preceding the study and are expected to remain in a permanent regime for the next 3 months.
- Mini Mental State Exam (MMSE) score> 24
Key exclusion criteria (3 listed)
- Any neurological condition other than PD or orthopedic disease (eg after a stroke with neurological signs, MSA, Parkinsonism, PSP, etc.) that may impair normal walking and balance.
- Significant cognitive impairment MMSE score<24
- Any medical, surgical, and / or psychiatric condition which, in the opinion of the investigator, prevents the patient from completing all aspects of the research.
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 |
|---|---|---|
| rehabilitation programsan 8-week multidisciplinary inpatient rehabilitation program | Behavioural | Ezera LaMarpeh rehabilitation programs |
Primary outcome
Immediate change in gait speed
Time frame: Immediate at the end of the program (8 weeks)
Gait speed will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
Community ambulation
Time frame: Immediate at the end of the program (8 weeks)
Will be assessed using a body-worn small lightweight device (AX3 - continuous logging accelerometer) that will be worn by the subjects for 7 days to monitor ADL.
2 secondary outcomes
Improve in motor function
Time frame: Immediate at the end of the program (8 weeks)
Motor function
Time frame: Immediate at the end of the program (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Tanya Gurevich, MD principal investigator
TASMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center at 2 sites 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 6 inclusion and 3 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 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Immediate change in gait speed (time frame: Immediate at the end of the program (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 27 Mar 2020.