Clinical trial NCT03406754: Multi-disciplinary Rehabilitation Program for Advanced Parkinson's Patients in the Community
Official title: Multi-disciplinary Rehabilitation Program for Advanced Parkinson's Patients in the Community
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with parkinson's disease participated in rehabilitation program

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immediate change in gait speed
timeFrame: Immediate at the end of the program (8 weeks)
measure: Community ambulation
timeFrame: Immediate at the end of the program (8 weeks)
Secondary outcomes:
measure: Improve in motor function
timeFrame: Immediate at the end of the program (8 weeks)
measure: Motor function
timeFrame: Immediate at the end of the program (8 weeks)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: TASMC
name: Tanya Gurevich, MD
role: PRINCIPAL_INVESTIGATOR
References: