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

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03406754
Collaborator
(none)
60
2
46
30
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: rehabilitation programs

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multi-disciplinary Rehabilitation Program for Advanced Parkinson's Patients in the Community
Actual Study Start Date :
Feb 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Ezera LaMarpeh rehabilitation programs

Participation in a rehabilitation program for 8 weeks

Behavioral: rehabilitation programs
an 8-week multidisciplinary inpatient rehabilitation program

Outcome Measures

Primary Outcome Measures

  1. Immediate change in gait speed [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.

  2. Community ambulation [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.

Secondary Outcome Measures

  1. Improve in motor function [Immediate at the end of the program (8 weeks)]

    Timed Up & Go scores

  2. Motor function [Immediate at the end of the program (8 weeks)]

    UPDRS III scores

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
2 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239

Sponsors and Collaborators

  • Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Tanya Gurevich, MD, TASMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT03406754
Other Study ID Numbers:
  • TASMC-17-TG-0745-CTIL
First Posted:
Jan 23, 2018
Last Update Posted:
Mar 27, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 27, 2020