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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02307019
Date of registration: 01/12/2014
Prospective Registration: No
Primary sponsor: Universidad de Granada
Public title: Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia CPA
Scientific title: Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia: Randomized Clinical Trial
Date of first enrolment: July 2014
Target sample size: 50
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02307019
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Care Provider, Investigator).  
Phase:  N/A
Countries of recruitment
Spain
Contacts
Name:     MÂȘ Encarnacion ME Aguilar, PhD
Address: 
Telephone:
Email:
Affiliation:  Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain
Key inclusion & exclusion criteria

Inclusion Criteria:

- Having an habitual role of carer (informal or formal).

- Being caring a mild-moderate poststroke patient with upper limb apraxia.

- Subjective manifestations of overload in the role as carer.

- More than two month as carer.

Exclusion Criteria:

- Uncooperativeness

- Being formed in the care of that kind of patients



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All
Health Condition(s) or Problem(s) studied
Performance Anxiety
Emotional Stress
Intervention(s)
Other: Program on general prevention of health
Other: Program on specific prevention of health
Primary Outcome(s)
Change from Baseline in Stroke Impact Scale (SIS-16) at 16 weeks [Time Frame: Sixteen weeks]
Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks [Time Frame: Eight weeks]
Secondary Outcome(s)
Change from Baseline in family APGAR at 8 weeks [Time Frame: Eight weeks]
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 8 weeks [Time Frame: Eight weeks]
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 8 weeks [Time Frame: Eight weeks]
Change from Baseline in General health questionnaire (GHQ-28) at 8 weeks [Time Frame: Eight weeks]
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 16 weeks [Time Frame: Sixteen weeks]
Change from Baseline in Barthel index at 8 weeks [Time Frame: Eight weeks]
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 16 weeks [Time Frame: Sixteen weeks]
Change from Baseline in family APGAR at 16 weeks [Time Frame: sixteen weeks]
Change from Baseline in Zarit questionnaire at 16 weeks [Time Frame: Sixteen weeks]
Change from Baseline in General health questionnaire (GHQ-28) at 16 weeks [Time Frame: Sixteen weeks]
Change from Baseline in Zarit questionnaire at 8 weeks [Time Frame: Eight weeks]
Change from Baseline in Barthel index at 16 weeks [Time Frame: Sixteen weeks]
Secondary ID(s)
Caregiver patients apraxia
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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