CClinicalTrials.gg
Status unknownNCT03406754Updated Mar 27, 2020

Multi-disciplinary Rehabilitation Program for Advanced Parkinson's Patients in the Community

An observational study in Parkinson's Disease, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 2 sites in Israel. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2020-03-27.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
40 Years to 95 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Parkinson's Disease

Browse trials for

03

Who can participate

Ages eligible
40 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with parkinson's disease participated in rehabilitation program

Inclusion criteria

  1. Diagnosis of idiopathic Parkinson's disease, as defined in the UK Brain Bank criteria
  2. Hoehn and Yahr stage I-III
  3. Patients who are taking anti-Parkinson's drugs.
  4. 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.
  5. Mini Mental State Exam (MMSE) score> 24
  6. Able to walk independently for at least 5 minutes with or without support.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Significant cognitive impairment MMSE score\<24
  3. Any medical, surgical, and / or psychiatric condition which, in the opinion of the investigator, prevents the patient from completing all aspects of the research.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Ezera LaMarpeh rehabilitation programs

    Participation in a rehabilitation program for 8 weeks

    Behavioral: rehabilitation programs

Interventions

  • Behavioralrehabilitation programs

    an 8-week multidisciplinary inpatient rehabilitation program

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediate at the end of the program (8 weeks)

  2. 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.

    Time frame: Immediate at the end of the program (8 weeks)

Secondary outcomes

  1. Improve in motor function

    Timed Up \& Go scores

    Time frame: Immediate at the end of the program (8 weeks)

  2. Motor function

    UPDRS III scores

    Time frame: Immediate at the end of the program (8 weeks)

06

Study locations

2 sites
  • Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
    Tel Aviv, 64239, Israel
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, 64239, Israel
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03406754
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Feb 1, 2018
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Mar 27, 2020

Study contacts

Tanya Gurevich, MD
principal investigator · TASMC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion