Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation
1 other identifier
observational
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedMarch 29, 2019
March 1, 2019
7 months
May 14, 2018
March 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caregiver Burden Inventory
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.
15 days
Study Arms (2)
Conventional Rehabilitation
Robotic Therapy
Interventions
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.
Eligibility Criteria
18-65 years old stroke patients who are not ambulatuar and dependent to their caregivers.
You may qualify if:
- Hemiplegia after stoke, Brunnstrom stages: stage 2-3 of lower limb minimum 6 months after stroke,
You may not qualify if:
- More than 1 stroke, aphasia, Dysphagia, other life life threatening diseases Independent ambulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziosmanpasa Taksim Research and Education Hospital
Istanbul, Turkey (Türkiye)
Related Publications (1)
Guler MA, Erhan B, Yilmaz Yalcinkaya E. Caregiver burden in stroke inpatients: a randomized study comparing robot-assisted gait training and conventional therapy. Acta Neurol Belg. 2021 Jun;121(3):729-736. doi: 10.1007/s13760-020-01465-5. Epub 2020 Aug 10.
PMID: 32776169DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 14, 2018
First Posted
May 24, 2018
Study Start
June 1, 2018
Primary Completion
December 30, 2018
Study Completion
January 30, 2019
Last Updated
March 29, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share