Clinical trial NCT01732679: Sunnaas International Network´s Stroke Study
Official title: A Prospective Multicenter Study of Stroke Rehabilitation in Seven Countries: Norway, China, USA, Russia, Israel, Palestine, and Sweden.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Stroke
Keywords: stroke, rehabilitation, multidisciplinary, description
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: China Rehabilitation Research Center
name: Sichuan 81 Rehabilitation Center, Chengdu
name: NYU Langoon medical center; The Rusk Institute of Rehabilitation Medicine, New York
name: City outpatient clinics №2,Petrozavodsk, Petrozavodsk
name: Sheba Medical Center
name: Al-Wafa Rehabilitation Hospital
name: Bethlehem Arab Society for Rehabilitation, Betlehem
name: Sahlgrenska University Hospital
First posted: 2012-11-26
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stroke patients in need of specialised comprehensive rehabilitation

Brief summary: A descriptive study of the stroke rehabilitation content in specialized clinics in seven countries: procedures for admission to rehabilitation, services available and provided to patients, as well as duration of the stay and discharge routines. An observational study of changes in regard to the physical function, quality of life and psycho-social factors in stroke patients before and after specialized rehabilitation

Detailed description: The descriptive study is two folded:

1) Description of the rehabilitation centers and the content the respective clinic presents as specialized rehabilitation.

A description of the expected change this input will result in in form of patients change in ADL and life satisfaction, with repeated measurements:

2a) reports of change in activities of daily living from baseline, to one fixed time (18-22 days in rehab),at discharge (which will vary),6 and 12 months post discharge (relatively fixed time) .

2b) reports of possible change in life satisfaction at baseline, discharge, 6 and 12 months after discharge.

Since the times for admission is expected to vary, which will be described under 1),we also want to measure if and how this difference might influence results. Therefore a fixed measure is inserted between admission and discharge. we have added a "relatively" fixed date at 6 months post stroke in order to see if change of function from specialized rehabilitation will differ in a longitudinal perspective, and if possible to see if the difference in time to admission (time from debut till admission in specialized rehabilitation)might influence results.

3) description of psycho- social factors at 6 and 12 months post discharge

Eligibility criteria: Inclusion Criteria:

* primary diagnosis of stroke, in need of specialized comprehensive rehabilitation, voluntary participation

Exclusion Criteria:

* sub-arachnoid hæmorrhage, tumor or other severe medical condition in combination with stroke that will influence outcomes

Primary outcomes:
measure: activities of daily living
timeFrame: patients will be followed 6 months from baseline testing
Secondary outcomes:
measure: The Life Satisfaction checklist (LiSat-11)
timeFrame: patients will be followed 6 months from baseline testing
Other outcomes:
measure: National Institutes of health stroke scale (NIHSS)
timeFrame: patients will be tested baseline and at discharge
measure: Modified Rankin Scale
timeFrame: patients will be followed 6 months from baseline testing
measure: Description of the psycho- social situation
timeFrame: 6 months after discharge
measure: description of institution
timeFrame: baseline
measure: registration data
timeFrame: baseline
Locations:
city: New York
country: United States
facility: Rusk Institute
state: New York
city: Chengdu
country: China
facility: Sichuan 81 rehabilitation center
state: Sichuan
city: Beijing
country: China
facility: China Research rehabilitation center
city: Tel Aviv
country: Israel
facility: Sheba medical center
city: Nesoddtangen
country: Norway
facility: Sunnaas rehabilitation Hospital
city: Betlehem
country: Palestinian Territory, occupied
facility: Betlehem arab society rehabilitation
state: Palestine
city: Gaza
country: Palestinian Territory, occupied
facility: El Wafa rehabilitation center
city: Petrozavodsk
country: Russian Federation
facility: Petrozavodsk
city: Gothenburgh
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
affiliation: Sunnaas rehabilitation hospital, University of Oslo
name: Johan K Stanghelle, PhD, MD
role: STUDY_DIRECTOR
References: