Cerebral Palsy (CP)ESPaCeNCT04509544
Satisfaction and Preferences About Motor Rehabilitation in People With Cerebral Palsy: ESPaCe, a French Survey
An observational study of Cerebral Palsy (CP), run by Fondation Paralysie Cérébrale.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy (CP)
- How many people
- 1,159 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals living in France with a motor impairment consistent with the definition of Cerebral Palsy
Who may be able to join
- Anyone living in France with a motor impairment consistent with the definition of Cerebral Palsy (whether undergoing or not motor rehabilitation sessions)
Who cannot join
- 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)
About this study
Official title: Patient's Preferences and Satisfaction About Physical Therapy Reported by Individuals With Cerebral Palsy and Families: ESPaCe, a National Survey in France.
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.
Read the 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.
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Physiotherapy, Satisfaction, Unmet needs, Motor Rehabilitation
- Medical subject headings
- Cerebral Palsy, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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
Measured: Day 1
Physiotherapy practices
Weekly frequency and duration (min) of physiotherapy sessions
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Jun 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Paralysie Cérébrale
- Sponsor type
- University, hospital or other
- Collaborators
- Kappa Santé, Envoludia, FFAIMC, CNSA, KLESIA, Fondation L'Oréal, SESEP
- Responsible party
- Sponsor
- Investigators
- Javier De La Cruz, MD, Study chair, Health Research Institute Imas12, Madrid, SpainMaria BODORIA, MD, Study director, Fondation Paralysie Cérébrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509544
- Sponsor's protocol ID
- ESPaCe
- Acronym
- ESPaCe
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Satisfaction, perceived unmet needs, barriers and expectations about motor rehabilitation of children, adolescents and adults with cerebral palsy to be provided as a function of age and GMFCS
Publications
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.
PubMed 10245370
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Preferences and Satisfaction About Physical Therapy Reported by Individuals With Cerebral Palsy and Families: ESPaCe, a National Survey in France.
- ClinicalTrials.gov ID
- NCT04509544
- Acronym / sponsor ID
- ESPaCe / ESPaCe
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Physiotherapy, Satisfaction, Unmet needs, Motor Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,159 participants (actual)
- Lead sponsor
- Fondation Paralysie CérébraleUniversity, hospital or other
- Collaborators
- Kappa Santé, Envoludia, FFAIMC, CNSA, KLESIA, Fondation L'Oréal, SESEP
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals living in France with a motor impairment consistent with the definition of Cerebral Palsy
Key inclusion criteria (1 listed)
- Anyone living in France with a motor impairment consistent with the definition of Cerebral Palsy (whether undergoing or not motor rehabilitation sessions)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determinants of satisfaction with motor rehabilitation in people with cerebral palsy
Time frame: Day 1
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.
Perceived needs, barrier to access and key expectations for physiotherapy services and associated motives
Time frame: Day 1
Likert scale ranging from 0 (never/not at all) to 5 (always/very high); Higher scores mean a worse outcome
Physiotherapy practices
Time frame: Day 1
Weekly frequency and duration (min) of physiotherapy sessions
1 secondary outcome
Analysis of the content of the free-text responses (ancillary study of ESPaCe)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Results publication: PubMed 10245370Larsen 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.
- rigin, foundations, rationale, governance of ESPaCe: A national survey on unmet needs and expectations' prioritization about motor rehabilitation reported by people with cerebral palsy and their family. Motricité cérébrale 2018;39(2):44-52.Link provided by the sponsor.
- Determinants of satisfaction with motor rehabilitation in people with cerebral palsy: A national survey in France (ESPaCe)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Satisfaction, perceived unmet needs, barriers and expectations about motor rehabilitation of children, adolescents and adults with cerebral palsy to be provided as a function of age and GMFCS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier De La Cruz, MD study chair
Health Research Institute Imas12, Madrid, Spain
Maria BODORIA, MD study director
Fondation Paralysie Cérébrale
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy (CP), run by Fondation Paralysie Cérébrale.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determinants of satisfaction with motor rehabilitation in people with cerebral palsy (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.