Cerebral Palsy (CP) Clinical Trial
— ESPaCeOfficial title:
Patient's Preferences and Satisfaction About Physical Therapy Reported by Individuals With Cerebral Palsy and Families: ESPaCe, a National Survey in France.
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 |
Verified date | July 2020 |
Source | Fondation Paralysie Cérébrale |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fondation Paralysie Cérébrale | CNSA, Envoludia, FFAIMC, Fondation L’Oréal, Kappa Santé, KLESIA, SESEP |
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
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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