Gait Evaluation in Haemophiliac Patients | NCT00824798

Studies
Gait Evaluation in Haemophiliac Patients

NCT00824798

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Jul 11, 2019Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Hemophilia A
Hemophilia B

Interventions

Not provided

Countries

Belgium

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

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jan 16, 2009

First Submission Date that Met QC Criteria

Jan 16, 2009

First Posted Date

Jan 19, 2009Estimated

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 10, 2019

Last Update Posted Date

Jul 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Joint damage secondary to recurrent haemarthroses and chronic synovitis represents the commonest clinical manifestation of haemophilia. Incapacitating pain, loss of joint stability and mobility, axial deviation, deterioration and decreased function are the most frequent complains in patients with severe haemophilic arthropathy In this context, the purpose of our study is to examine and analyse specific changes in gait in patients suffering from haemophilic arthropathy and determine the impact on health-related quality of life in terms of conceptual components of pain and stiffness, psychosocial stress, disability, and activity limitations as recommended by the International Classification of Function (ICF) recently published by the World Health Organization.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
haemophiliacs A and B		haemophiliacs A and B mild, moderate or severe from 4 to 80 years old, with or without inhibitors.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluate specific changes in gait in patients suffering from haemophilic arthropathy		from inclusion in the study until 1 year after inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

haemophilia A or B
aged more than 4 years

Exclusion Criteria:

impossibility to walk on a treadmill
recent joint haemarthrosis or muscle haematoma

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

haemophilia A or B, mild, moderate or severe.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
sebastien lobet	sebastien.lobet@uclouvain.be	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires Saint-Luc		Brussels		1200	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20398067	Result	Lobet S, Detrembleur C, Francq B, Hermans C. Natural progression of blood-induced joint damage in patients with haemophilia: clinical relevance and reproducibility of three-dimensional gait analysis. Haemophilia. 2010 Sep 1;16(5):813-21. doi: 10.1111/j.1365-2516.2010.02245.x. Epub 2010 Apr 7.
21371180	Result

ID	Term
D006467	Hemophilia A
D002836	Hemophilia B
D007592	Joint Diseases

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases