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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03406754
• Other study ID #: TASMC-17-TG-0745-CTIL
• Status: Active, not recruiting
• Start date: February 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Israel	Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Improve in motor function	Timed Up & Go scores	Immediate at the end of the program (8 weeks)
Secondary	Motor function	UPDRS III scores	Immediate at the end of the program (8 weeks)