Clinical trial NCT02307019: Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia
Official title: Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance Anxiety
Emotional Stress
Keywords: Caregivers
Apraxias
Stroke
Cerebral Stroke
Rehabilitation
Pragmatic Clinical Trials as Topic
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the effects of a intervention on a specific health prevention/intervention program aimed at caregivers of mild and moderate patients post stroke with upper limb apraxia in comparison to a control group with a no specific formation in that kind of patients.

Detailed description: Patients with Upper limb apraxia after stroke have severe problems to adapt their daily life.

The upper limb apraxia syndrome affects the performance of skilled movements carried out by the upper limbs and provoke that many patients´activities have to be made by their main caregiver or carers.

Caregivers usually have to occupy much time and efforts for caring their familiar or client, and it can result in a overload in different areas of the caregiver health.

Few data are available on the effectiveness of interventions in caregivers that informally works with that kind of patients.

The specific prevention health program is based on improving the awareness of the assistance that the caregivers provide, and knowing the process of the information that carer has to give to the patient while the patients have their activities made.

Eligibility 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

Primary outcomes:
measure: Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Stroke Impact Scale (SIS-16) at 16 weeks
timeFrame: Sixteen weeks
Secondary outcomes:
measure: Change from Baseline in Barthel index at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Barthel index at 16 weeks
timeFrame: Sixteen weeks
measure: Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 16 weeks
timeFrame: Sixteen weeks
measure: Change from Baseline in General health questionnaire (GHQ-28) at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in General health questionnaire (GHQ-28) at 16 weeks
timeFrame: Sixteen weeks
measure: Change from Baseline in Zarit questionnaire at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Zarit questionnaire at 16 weeks
timeFrame: Sixteen weeks
measure: Change from Baseline in family APGAR at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in family APGAR at 16 weeks
timeFrame: sixteen weeks
measure: Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 16 weeks
timeFrame: Sixteen weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
state: Andalucía
Study officials:
affiliation: Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain
name: Mª Encarnacion ME Aguilar, PhD
role: PRINCIPAL_INVESTIGATOR
References: