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

• Conditions: Parkinson's Disease
• Interventions: Behavioral: rehabilitation programs

• Registration Number: NCT03406754
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

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 Timeline

• Study First Submitted: 2018-01-07
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-23
• Study Start: 2018-02-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-27
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ezera LaMarpeh rehabilitation programs	rehabilitation programs	Participation in a rehabilitation program for 8 weeks

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
Improve in motor function	Immediate at the end of the program (8 weeks)	Timed Up \& Go scores
Motor function	Immediate at the end of the program (8 weeks)	UPDRS III scores

Trial Locations

Locations (2)

Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel