NCT03406754

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

3.8 years

First QC Date

January 7, 2018

Last Update Submit

March 25, 2020

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Immediate at the end of the program (8 weeks)

Secondary Outcomes (2)

  • Improve in motor function

    Immediate at the end of the program (8 weeks)

  • Motor function

    Immediate at the end of the program (8 weeks)

Study Arms (1)

Ezera LaMarpeh rehabilitation programs

Participation in a rehabilitation program for 8 weeks

Behavioral: rehabilitation programs

Interventions

rehabilitation programsBEHAVIORAL

an 8-week multidisciplinary inpatient rehabilitation program

Ezera LaMarpeh rehabilitation programs

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with parkinson's disease participated in rehabilitation program

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Tanya Gurevich, MD

    TASMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2018

First Posted

January 23, 2018

Study Start

February 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)