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Trial record 53 of 458 for:    Inherited Bleeding Disorder

Motor Proficiency of People With Bleeding Disorders Using the BOT-2 (TM)

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ClinicalTrials.gov Identifier: NCT02279199
Recruitment Status : Active, not recruiting
First Posted : October 31, 2014
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
David Oleson, Oregon Health and Science University

Brief Summary:

The purpose of this study is to find out if gross motor skills of children and young adults with bleeding disorders are different from those without bleeding disorders. The investigators will use the standardized motor test the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2 tm). The second purpose is to establish if history of joint disease secondary to bleeding affects gross motor skills.

  1. Participants and setting: Subjects will include up to 100 male youth and young adults, ages 4 to 21, recruited from the patient population of the Hemophilia Treatment Center at OHSU. A mailing that describes the study may be sent to all potential subjects who receive care through the Hemophilia Treatment Center at OHSU. Data collection will occur at either clinic visits or in the home. Information, including history of change in joint structure and synovium, from existing bleeding disorder repositories at OHSU will also be used.
  2. Design and Procedures: Research will be done using a prospective, cross-sectional study design to examine any relationship between a diagnosis of bleeding disorder and gross motor development. The gross motor ability of children and young adults with bleeding disorders who meet the inclusion criteria will be compared to sex-specific normative data from a standardized motor test. Information about age, type of hemophilia, presence of an inhibitor, type of management used, body composition, range of motion, and hand strength will also be collected through direct measurement and chart review. The information collected will be entered into a repository. A subject may choose to opt out of the repository while still participating in the research study. In addition, information from a current hemophilia repository will be compared to gross motor ability scores to determine if joint disease is related to skill level in this group of people.
  3. Proposed analyses: Two-tailed t tests and logistic regression will be used to determine if there are any significant differences.

Condition or disease
Hemophilia

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 5 Years
Official Title: Assessment of Motor Proficiency in People With Bleeding Disorders Using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2™)
Actual Study Start Date : January 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Control
Normative data from standardized assessment
Hemophilia
Persons aged 4-21 with any severity of hemophilia A or B



Primary Outcome Measures :
  1. Motor Proficiency [ Time Frame: At point of testing ]
    Motor proficiency of children and young adults with hemophilia compared to age-matched standardized norms


Secondary Outcome Measures :
  1. Joint health using Hemophilia Joint Health Score (HJHS) [ Time Frame: at point of testing ]
    Comparison of HJHS to standardized motor proficiency assessment to determine relationship between joint health and motor development



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children and young adults with hemophilia A or hemophilia B, between the ages of 4 years, 0 months to 21 years, 11 months.
Criteria

Inclusion Criteria:

  • Patient of the Hemophilia Treatment Center at OHSU
  • Male
  • Aged 4 years, 0 months to 21 years, 11 months
  • Diagnosis of bleeding disorder

Exclusion Criteria:

  • Acute bleed or injury in the last two weeks that prevents activity
  • Diagnosed developmental delay

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279199


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Patient's home
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University

Additional Information:

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Responsible Party: David Oleson, David Oleson, PT, PCS, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02279199     History of Changes
Other Study ID Numbers: Motor Proficiency & Hemophilia
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a repository that is part of the consent process. Subjects can opt out if desired.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: The manuscript is in progress. Once published, data will be available via the IRB approved repository if all conditions of the recipient IRB and the OHSU IRB are met.
Access Criteria: Approval of recipient and OHSU IRBs, respository guardian's approval.
Keywords provided by David Oleson, Oregon Health and Science University:
hemophilia
joint health
motor development
motor proficiency
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases