French Translation/Adaptation of AHEMD-SR (FR-AHEMD) | NCT06469840

Studies
French Translation/Adaptation of AHEMD-SR (FR-AHEMD)

NCT06469840

Sponsor

Fondation Ildys

Status

Unknown status

Last Update Posted

Jul 9, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Motor Disorders

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2024Actual

Primary Completion Date

Jan 2025Estimated

Completion Date

Jan 2025Estimated

First Submitted Date

Jun 17, 2024

First Submission Date that Met QC Criteria

Jun 17, 2024

First Posted Date

Jun 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2024

Last Update Posted Date

Jul 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to develop a French translation and adaptation of the original English version of the AHEMD-SR.

Detailed Description

The AHEMD-SR was developed in 2005 to assess the opportunities offered to children aged 18 to 42 months to support their motor development in the home environment. The questionnaire is reliable and valid and is regularly used by researchers and practitioners to assess and develop strategies to improve the stimulating properties of the home. To date, the AHEMD-SR has been translated into eight languages, but no French translation exists.

The study will include a translation of the AHEMD-SR into French and a cultural validation of the French version of the questionnaire with a sample of parents of children diagnosed with delayed motor development and a panel of paediatric rehabilitation experts.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parents		Parents of a child aged 18 to 42 months with a diagnosis of delayed motor development
Expert group		Pediatric rehabilitation professionals

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reliability of the French version of the original English version of the AHEMD-SR		July 2024 - October 2024

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Parents Group :

Inclusion Criteria:

Parents of a child aged 18 to 42 months with a diagnosis of delayed motor development
Taken in charge in one of the participating centers for an intensive motor rehabilitation training
Francophone by birth

Exclusion Criteria:

Parent opposing participation in the study

Experts Group :

Inclusion Criteria:

Professional
Holding a French state diploma in the field of rehabilitation
Participating in an intensive motor rehabilitation training in one of the participating centres.
Proof of experience in paediatric rehabilitation (lasting 5 years).
Francophone by birth

Non-inclusion criteria :

- Expert opposing participation in the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Parents of a child aged 18 to 42 months with a diagnosis of delayed motor development
Pediatric rehabilitation professionals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manon LE GOFF	Contact	0298028308	+33	manon.legoff@ildys.org
Matthieu PICHELIN	Contact	0298293915	+33	matthieu.pichelin@ildys.org

Overall Officials

Name	Affiliation	Role
Rodolphe BAILLY, PhD	Fondation Ildys	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Les Capucins Angers	Recruiting	Angers			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20874835	Background	Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.
16128482	Background	Rodrigues LP, Saraiva L, Gabbard C. Development and construct validation of an inventory for assessing the home environment for motor development. Res Q Exerc Sport. 2005 Jun;76(2):140-8. doi: 10.1080/02701367.2005.10599276.