Clinical trial NCT04509544: Satisfaction and Preferences About Motor Rehabilitation in People With Cerebral Palsy: ESPaCe, a French Survey
Official title: Patient's Preferences and Satisfaction About Physical Therapy Reported by Individuals With Cerebral Palsy and Families: ESPaCe, a National Survey in France.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy (CP)
Keywords: Physiotherapy
Satisfaction
Unmet needs
Motor Rehabilitation
Lead sponsor: Fondation Paralysie Cérébrale
Sponsor class: OTHER
Collaborators: name: Kappa Santé
name: Envoludia
name: FFAIMC
name: CNSA
name: KLESIA
name: Fondation L'Oréal
name: SESEP
First posted: 2020-08-12
Enrollment: 1159
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals living in France with a motor impairment consistent with the definition of Cerebral Palsy

Brief summary: This national cross-sectional ESPaCe survey (Enquête Satisfaction Paralysie Cérébrale) was conducted to evaluate perceived needs, barriers and expectations regarding Motor Rehabilitation services further to a preliminary qualitative work.

From June 2016 to June 2017, participants answered a web-based or postal questionnaire, by themselves or with the help of a family member.

Detailed description: ESPaCe was a cross-sectional national survey designed to collect data on Cerebral Palsy (CP) motor rehabilitation from individuals with CP and their families in France.

Needs, barriers and expectations regarding PT services were identified in a series of standardised individual interviews and group discussions developed by a multidisciplinary group composed of individuals with cerebral palsy, families, professional organisation representatives, therapists and rehabilitation specialists, described as "ESPaCe working group". The issues identified in the preparatory qualitative work were structured in a questionnaire and tested in a feasibility study.This study was carried out in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki). Informed consent was not required for this survey according to current French legislation.The study included all individuals with cerebral palsy aged 2 y.o. or more, whether they were receiving physiotherapy (PT) services at the time of the survey or not. CP features were self-reported. Eligibility was confirmed by cross-checking the responses to questionnaire items related to history, diagnosis and clinical description of CP. The questionnaire was completed either by individuals with cerebral palsy, a family member or a caretaker.

Participants were described with the following characteristics: age, gender, Gross Motor Function Classification System (GMFCS) level, CP subtype, associated impairments, frequency of pain, mother education (as a proxy for socio-economic status), and PT service provider.

Participation in the ESPaCe survey was promoted through local and national patient advocacy groups and professional networks. The questionnaire was completed online or mailed-in. Data collection was open from June 2016 to June 2017.Participation in the ESPaCe survey was promoted through local and national patient advocacy groups and professional networks.

Eligibility criteria: Inclusion Criteria:

* Anyone living in France with a motor impairment consistent with the definition of Cerebral Palsy (whether undergoing or not motor rehabilitation sessions)

Exclusion Criteria:

* Individuals who were not diagnosed with CP or when descriptive information provided in the survey regarding motor impairment was insufficiently detailed or did not meet the definition of CP (e.g., progressive disorders).
* Individuals for whom a questionnaire was already completed by a family member or caregiver

Of note main analyses will be run for participants \> 2 years old (data for participants \< 2 y o considered as exploratory data)

Primary outcomes:
measure: Determinants of satisfaction with motor rehabilitation in people with cerebral palsy
timeFrame: Day 1
measure: Perceived needs, barrier to access and key expectations for physiotherapy services and associated motives
timeFrame: Day 1
measure: Physiotherapy practices
timeFrame: Day 1
Secondary outcomes:
measure: Analysis of the content of the free-text responses (ancillary study of ESPaCe)
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Health Research Institute Imas12, Madrid, Spain
name: Javier De La Cruz, MD
role: STUDY_CHAIR
affiliation: Fondation Paralysie Cérébrale
name: Maria BODORIA, MD
role: STUDY_DIRECTOR
References:
citation: Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.