Status of People With Cerebral Palsy and Their Caregivers During COVID-19 Pandemic

Cerebral Palsy Clinical Trial

Official title:

Assessment of the Biopsychosocial Status of People With Cerebral Palsy and Related Diseases and Their Caregivers During the COVID-19 Pandemic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753632
• Other study ID #: DF0095UG
• Status: Recruiting
• Start date: March 9, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: March 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

COVID-19, as well as the collateral situations that it entails, has been causing panic, anguish and anxiety that has generated biopsychosocial problems in society affecting not only the physical and social level but also the mental health and well-being.

The main objective of this research project is to assess the biopsychosocial status of people with cerebral palsy and related diseases and their caregivers during the COVID-19 pandemic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cerebral palsy patients and their caregivers

Exclusion Criteria:

• Patients or caregivers with Cognitive impairment

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire of Knowledge, attitudes and practice towards COVID-19	Questionnaire to evaluate the knowledge about COVID-19. It includes 12 items. Patients have to answer true/false. Higher puntuation indicates better knowledge results.	Baseline
Primary	Caregiver COVID-19 limitation scale	This scale is used to examine the impact of the COVID-19 pandemic on caregivers. Scores ranged from 1 to 10, and a higher score indicates more limitations.	Baseline
Primary	Fear of Coronavirus-19 Scale	It is a scale that assesses the fear of COVID-19. It consists of 7 items scored on a 5-item Likert scale. The higher the score, the more fear.	Baseline
Primary	Covid-19 Stress Scale (CSS)	COVID stress scale (CSS): is a 36-item COVID Stress Scale (CSS) to measure these features, as they pertain to COVID-19. The CSS were developed to better understand and assess COVID-19-related distress. The scales were intentionally designed so they could be readily adapted for future pandemics.	Baseline
Primary	Coronavirus Anxiety Scale (CAS)	Coronavirus anxiety scale (CAS): It is a scale that measures the anxiety generated by COVID-19 in the last two weeks.; It presents 5 items and a score> 9 indicates dysfunctional anxiety associated with the pandemic.	Baseline
Primary	Connor-Davidson Resilience Scale-10	Connor-Davidson Resilience Scale (CD-RISC) was used to measure resilience. Respondents are asked to answer on a five-point Likert scale (0 = totally disagree to 4 = totally agree)	Baseline
Primary	COPE	The Brief-COPE is a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. "Coping" is defined broadly as an effort used to minimize distress associated with negative life experiences	Baseline
Primary	Medical Outcomes Study-Social Support Survey	This brief, self-administered Social Support Survey instrument was developed for patients in the Medical Outcomes Study (MOS), a two-year study of patients with chronic conditions. Higher puntuations indicate higher social support.	Baseline
Primary	Zarit Burden Inventory	The Zarit Burden Inventory examines burden associated with functional/behavioural impairments and the home care situation. Higher puntuations indicate higher burden.	Baseline
Secondary	Euroqol-5D	The perception of the level of health and the quality of life were evaluated with the questionnaire European Quality of; Life-5 Dimensions (EQ-5D). It is composed of 2 parts in which health status is assessed: Descriptive system: It consists on 5 dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients classify their health status in 3 severity levels: having no problems, having some or moderate problems, being unable to do/having extreme problems. Visual Analog Scale, by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)	Baseline
Secondary	Hospital Anxiety and Depression Scale	Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS) . This scale is composed of 14 items divided into two subscales, 7 items of anxiety and 7 items of depression, involving higher values worse psycho-emotional state.	Baseline
Secondary	Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances in the previous month.	Baseline
Secondary	International Physical Activity Questionnaire	The International Physical Activity Questionnaire (IPAQ) was developed to measure health-related physical activity (PA) in populations. Higher scores indicates higher physical activity levels.	Baseline
Secondary	Functional independence measure	The Functional Independence Measure (FIM) is an 18-item measurement tool that explores an individual's physical, psychological and social function. Higher scores mean a better outcome.	Baseline
Secondary	Gross motor function classification system	The GMFCS, or Gross Motor Function Classification System, is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.	Baseline
Secondary	Manual Agility Classification System	The Manual Ability Classification System (MACS) describes how children with cerebral palsy use their hands to handle objects in daily activities. MACS describes five levels.	Baseline