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Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation

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ClinicalTrials.gov Identifier: NCT03535467
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Mehmet Akif GÜLER, Gaziosmanpasa Taksim Research and Education Hospital

Brief Summary:
Caregiver's burden in rehabilitation is important for both patients physical and mental health. Therefore researching caregivers burden and treatment of any depression or associated any psychological disorders of caregiver is crucial.

Condition or disease Intervention/treatment
Stroke Rehabilitation and Caregivers Other: Caregiver's Burden Inventory

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : September 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Conventional Rehabilitation Other: Caregiver's Burden Inventory
The Caregiver Burden Inventory was developed by Canadian researchers.The authors of the instrument stress the importance of using a multidimensional measurement of burden with separate scores for each dimension in as opposed to global or uni-dimensional scores.

Robotic Therapy Other: Caregiver's Burden Inventory
The Caregiver Burden Inventory was developed by Canadian researchers.The authors of the instrument stress the importance of using a multidimensional measurement of burden with separate scores for each dimension in as opposed to global or uni-dimensional scores.




Primary Outcome Measures :
  1. Caregiver Burden Inventory [ Time Frame: 15 days ]
    Caregiver Burden Inventory(CBI) first designed by Novak and Guest in 1989 to measure burden of patient's caregiver. Caregiver can be a relative or a professional. CBI consists of 5 different subscales(Time Dependency Items(5 question),Development Items(5 question),Physical Health Items(4 question),Emotional Health Items(5 question),Social Relationship Items(5 question)), a total of 24 questions. Every question should be answered by the caregiver according to a likert scale (0=Never,1=Rarely,2=Sometimes,3=Quite Frequently,4=Nearly Always) and a total of 96 points. 36 point is a limit to a professional help for caregiver and the higher the points get there is more burden for caregiver.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
18-65 years old stroke patients who are not ambulatuar and dependent to their caregivers.
Criteria

Inclusion Criteria:

  • Hemiplegia after stoke, Brunnstrom stages: stage 2-3 of lower limb minimum 6 months after stroke,

Exclusion Criteria:

  • More than 1 stroke, aphasia, Dysphagia, other life life threatening diseases Independent ambulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535467


Locations
Turkey
Gaziosmanpasa Taksim Research and Education Hospital Recruiting
Istanbul, Turkey
Contact: Mehmet Akif Güler, Dr.    +905054930098    makifguler89@gmail.com   
Sponsors and Collaborators
Gaziosmanpasa Taksim Research and Education Hospital

Responsible Party: Mehmet Akif GÜLER, Principal Investigator, Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT03535467     History of Changes
Other Study ID Numbers: GaziosmanpasaTREH1
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mehmet Akif GÜLER, Gaziosmanpasa Taksim Research and Education Hospital:
Caregivers
Exoskeleton Device
Stroke Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases