CClinicalTrials.gg
Status unknownNCT04753632Updated Mar 26, 2021

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

An observational study in Cerebral Palsy, sponsored by Universidad de Granada. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-26.

Sponsored by Universidad de Granada · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Palsy
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 60 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Cerebral palsy patients and their caregivers

Inclusion criteria

  • Cerebral palsy patients and their caregivers

Exclusion criteria

Exclusion Criteria:

  • Patients or caregivers with Cognitive impairment
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cerebral palsy patients and caregivers

    Cerebral palsy patients and caregivers

  • Healthy people and their caregivers

    Healthy people and their caregivers

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

  6. 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)

    Time frame: Baseline

  7. 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

    Time frame: Baseline

  8. 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.

    Time frame: Baseline

  9. Zarit Burden Inventory

    The Zarit Burden Inventory examines burden associated with functional/behavioural impairments and the home care situation. Higher puntuations indicate higher burden.

    Time frame: Baseline

Secondary outcomes

  1. 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)

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: Baseline

  7. 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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Department of Physical Therapy
    Granada, 18016, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04753632
Lead sponsor
Universidad de Granada
Responsible party
Marie Carmen Valenza (Principal Investigator; PT; PhD, Universidad de Granada) — Principal investigator
First posted
Feb 15, 2021
Start date
Mar 9, 2021
Primary completion
May 15, 2021 (estimated)
Completion
Jun 15, 2021 (estimated)
Last update
Mar 26, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion