Sunnaas International Network´s Stroke Study (SINs)
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Purpose
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
| Condition | Intervention |
|---|---|
|
Stroke Rehabilitation in Specialised Rehabilitation Clinics |
Other: multidisciplinary rehabilitation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Multicenter Study of Stroke Rehabilitation in Seven Countries: Norway, China, USA, Russia, Israel, Palestine, and Sweden. |
- activities of daily living [ Time Frame: patients will be followed 6 months from baseline testing ] [ Designated as safety issue: Yes ]Changes in Activities of daily living are monitored as an indirect evaluation of how the specialized rehabilitation may influence patients' outcomes.
- The Life Satisfaction checklist (LiSat-11) [ Time Frame: patients will be followed 6 months from baseline testing ] [ Designated as safety issue: No ]LiSat-11 consists of patients estimations of satisfaction with life as a whole as well as satisfaction in ten specific domains: vocation, economy, leisure, contacts, sexual life, activities of daily living (ADL), family life, partner relationship, somatic health, psychological health
- National Institutes of health stroke scale (NIHSS) [ Time Frame: patients will be tested baseline and at discharge ] [ Designated as safety issue: No ]
NIHSS is a clinical stroke assessment tool to evaluate and document neurological status in acute stroke patients.
The timeframe for discharge will vary with the different clinics since this is one of the differences expected.
Length of stay is one of the outcomes
- Modified Rankin Scale [ Time Frame: patients will be followed 6 months from baseline testing ] [ Designated as safety issue: No ]it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke
- Description of the psycho- social situation [ Time Frame: 6 months after discharge ] [ Designated as safety issue: No ]A semi - structured interview, with focus on the psycho-social situation 6 months after rehabilitation, will be performed. Questions will focus on the work-, financial situation, what sort of follow-up services, recreational- and social activities are available, and what is considered the major change of life after stroke.
- description of institution [ Time Frame: baseline ] [ Designated as safety issue: No ]a questionaire where the participants are required to describe the services available, methods used in rehabilitation, intensity of training, procedures for intake and discharge
- registration data [ Time Frame: baseline ] [ Designated as safety issue: No ]questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication
| Estimated Enrollment: | 270 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
stroke patients
specialized rehabilitation in a multidisciplinary team, Sunnaas International Network
|
Other: multidisciplinary 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. This is reported once.
So follows 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) and at discharge (which will vary) and at 6 months after discharge (relatively fixed time) .
2b) reports of possible change in life satisfaction at baseline, discharge and 6 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
stroke patients in need of specialised comprehensive rehabilitation
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
Contacts and Locations| Contact: Birgitta M Langhammer, PhD RPT | +4722452510 | Birgitta.Langhammer@hioa.no |
| Contact: Johan K Stanghelle, PhD, MD | +4766969173 | johan.stanghelle@sunnaas.no |
| United States, New York | |
| Rusk Institute | Not yet recruiting |
| New York, New York, United States | |
| Contact: Tamara Buschnik, PhD OT 212-263-6547 Tamara.Bushnik@nyumc.org | |
| Sub-Investigator: Annika Ginsberg | |
| China, Sichuan | |
| Sichuan 81 rehabilitation center | Recruiting |
| Chengdu, Sichuan, China | |
| Contact: Xie Li, MD +862813981865226 444158175@qq.com | |
| Contact: Wu Yuru 766497867@qq.com | |
| China | |
| China Research rehabilitation center | Recruiting |
| Beijing, China | |
| Contact: Zhang Tong, PhD MD +8613701395491 zhangtongzt61611@sohu.com | |
| Contact: Xiaoxia Du, PhD MD +8615010930096 DUxiaoxia2005@gmail.com | |
| Sub-Investigator: Li Chao Jinzi, Msc | |
| Israel | |
| Sheba medical center | Not yet recruiting |
| Tel Aviv, Israel | |
| Contact: Ofer Keren, MD +35305183 ofkeren@zahav.net.il | |
| Contact: Fabiana Jachniuk, MD +35305183 fabijach@gmail.com | |
| Sub-Investigator: Yael Amzallag, OT | |
| Norway | |
| Sunnaas rehabilitation Hospital | Recruiting |
| Nesoddtangen, Norway | |
| Contact: Frank Becker, PhD, MD +4766969000 Frank.Becker@sunnaas.no | |
| Contact: Anne Marthe Sanders, Msc +4766969000 Anne-Marthe.Sanders@sunnaas.no | |
| Principal Investigator: Frank Becker, PhD Md | |
| Palestinian Territories, Occupied | |
| Betlehem arab society rehabilitation | Recruiting |
| Betlehem, Palestine, Palestinian Territories, Occupied | |
| Contact: Elias Saba, MD Elias-saba@hotmail.com | |
| Contact: Edmund Shehadeh Basr@basr.org | |
| Sub-Investigator: Samir Banura | |
| El Wafa rehabilitation center | Recruiting |
| Gaza, Palestinian Territories, Occupied | |
| Contact: Khamis Elessi, MD +00970599868034 Khamis1000000@googlemail.com | |
| Contact: Fuad Luzon, Msc OT +00970599485898 fuadluzon@yahoo.com | |
| Russian Federation | |
| Petrozavodsk | Recruiting |
| Petrozavodsk, Russian Federation | |
| Contact: Maria Panchenko, MD Pan-maria@yandex.ru | |
| Contact: Svetlana Berlogina, MD +79095726864 sharparsv@yandex.ru | |
| Sub-Investigator: Elena Retner, ST | |
| Sweden | |
| Sahlgrenska university hospital | Recruiting |
| Gothenburgh, Sweden | |
| Contact: Åsa Lundgren Nilsson, PhD OT +46313422414 Asa.Lundgren-Nilsson@neuro.gu.se | |
| Contact: Karin Blomqvist, MD +46704534332 karin.blomqvist@vgregion.se | |
| Sub-Investigator: Linda Johnsson | |
More Information
No publications provided
| Responsible Party: | Birgitta Langhammer, Associate professor/ project manager, Sunnaas Rehabilitation Hospital |
| ClinicalTrials.gov Identifier: | NCT01732679 History of Changes |
| Other Study ID Numbers: | SINs stroke study |
| Study First Received: | November 8, 2012 |
| Last Updated: | November 23, 2012 |
| Health Authority: | Norway: Sunnaas International Network |
Keywords provided by Sunnaas Rehabilitation Hospital:
|
stroke, rehabilitation, multidisciplinary, description |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 19, 2013