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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04509544
Other study ID # ESPaCe
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2016
Est. completion date June 30, 2017

Study information

Verified date July 2020
Source Fondation Paralysie Cérébrale
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1159
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (8)

Lead Sponsor Collaborator
Fondation Paralysie Cérébrale CNSA, Envoludia, FFAIMC, Fondation L’Oréal, Kappa Santé, KLESIA, SESEP

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Determinants of satisfaction with motor rehabilitation in people with cerebral palsy Validated French version of Client Satisfaction Questionnaire (CSQ-8)The CSQ-8 includes 8 items, each rated on a 4-point Likert scale, ranging from 1 to 4. The CSQ-8 total score ranges from 8 to 32. A higher score represents greater satisfaction. Day 1
Primary Perceived needs, barrier to access and key expectations for physiotherapy services and associated motives Likert scale ranging from 0 (never/not at all) to 5 (always/very high); Higher scores mean a worse outcome Day 1
Primary Physiotherapy practices Weekly frequency and duration (min) of physiotherapy sessions Day 1
Secondary Analysis of the content of the free-text responses (ancillary study of ESPaCe) Participants' comments were coded and compiled into themes using a text-mining approach allowing to provide context to supplement the results from the closed questions as well as identify any issues or opinions that were not covered by the closed questions. Day 1
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