Stroke Rehabilitation and CaregiversNCT03535467
Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation
An observational study of Stroke Rehabilitation and Caregivers, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke Rehabilitation and Caregivers
- What is being tested?
- Caregiver's Burden Inventory
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 30 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-65 years old stroke patients who are not ambulatuar and dependent to their caregivers.
Who may be able to join
- Hemiplegia after stoke, Brunnstrom stages: stage 2-3 of lower limb minimum 6 months after stroke,
Who cannot join
- More than 1 stroke, aphasia, Dysphagia, other life life threatening diseases Independent ambulation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Taksim Research and Education Hospital
Istanbul
About this study
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.
- Conditions
- Stroke Rehabilitation and Caregivers
- Being tested
- Caregiver's Burden Inventory
- Keywords
- Caregivers, Exoskeleton Device, Stroke Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver's Burden InventoryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rehabilitation | Not described Receives: Other: Caregiver's Burden Inventory | |
| Robotic Therapy | Not described Receives: Other: Caregiver's Burden Inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Jun 2018
- Primary completion30 Dec 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke Rehabilitation and CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535467
- Sponsor's protocol ID
- GaziosmanpasaTREH1
- Status last verified
- Mar 2019
- First submitted
- 14 May 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32776169
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation
- ClinicalTrials.gov ID
- NCT03535467
- Acronym / sponsor ID
- GaziosmanpasaTREH1
- Conditions
- Stroke Rehabilitation and Caregivers
- Keywords
- Caregivers, Exoskeleton Device, Stroke Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Rehabilitation | – | Other: Caregiver's Burden Inventory |
| Robotic Therapy | – | Other: Caregiver's Burden Inventory |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-65 years old stroke patients who are not ambulatuar and dependent to their caregivers.
Key inclusion criteria (1 listed)
- Hemiplegia after stoke, Brunnstrom stages: stage 2-3 of lower limb minimum 6 months after stroke,
Key exclusion criteria (1 listed)
- More than 1 stroke, aphasia, Dysphagia, other life life threatening diseases Independent ambulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver's Burden InventoryThe 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. | Other | Conventional Rehabilitation, Robotic Therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Derived from this study: PubMed 32776169Guler 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.
- Individual participant dataSharing planned: No
Related trials for Stroke Rehabilitation and Caregivers
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Ischemic Stroke, Cognitive Impairment
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Brain Injuries, Acute, Brain Tumor Adult
Recruiting
Efficacy and Sustainability of a Carepartner-Integrated Telerehabilitation Program for Persons With Stroke
Stroke, Caregiver Burden
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Rehabilitation and Caregivers, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden Inventory (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03535467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.