NCT01732679

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
7 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

November 8, 2012

Last Update Submit

April 24, 2017

Conditions

Cerebral Stroke

Keywords

stroke, rehabilitation, multidisciplinary, description

Outcome Measures

Primary Outcomes (1)

  • activities of daily living

    Changes in Activities of daily living are monitored as an indirect evaluation of how the specialized rehabilitation may influence patients' outcomes.

    patients will be followed 6 months from baseline testing

Secondary Outcomes (1)

  • The Life Satisfaction checklist (LiSat-11)

    patients will be followed 6 months from baseline testing

Other Outcomes (5)

  • National Institutes of health stroke scale (NIHSS)

    patients will be tested baseline and at discharge

  • Modified Rankin Scale

    patients will be followed 6 months from baseline testing

  • Description of the psycho- social situation

    6 months after discharge

  • +2 more other outcomes

Study Arms (1)

stroke patients

specialized rehabilitation in a multidisciplinary team, Sunnaas International Network

Other: rehabilitation

Interventions

rehabilitationOTHER

Description of specialized rehabilitation and Influence on activities, life satisfaction, psycho social aspects 6 and 12 months post discharge

Also known as: multidisciplinary specialised rehabilitation
stroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stroke patients in need of specialised comprehensive rehabilitation

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rusk Institute

New York, New York, United States

Location

Sichuan 81 rehabilitation center

Chengdu, Sichuan, China

Location

China Research rehabilitation center

Beijing, China

Location

Sheba medical center

Tel Aviv, Israel

Location

Sunnaas rehabilitation Hospital

Nesoddtangen, Norway

Location

Betlehem arab society rehabilitation

Bethlehem, Palestine, Palestinian Territories

Location

El Wafa rehabilitation center

Gaza, Palestinian Territories

Location

Petrozavodsk

Petrozavodsk, Russia

Location

Sahlgrenska university hospital

Gothenburgh, Sweden

Location

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Johan K Stanghelle, PhD, MD

    Sunnaas rehabilitation hospital, University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor/ project manager

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 26, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

October 1, 2016

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

CN(2)NO(1)PA(2)RU(1)SE(1)US(1)IL(1)