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

NCT02279199 | Completed

• 1 other identifier: Motor Proficiency & Hemophilia
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

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. 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. 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. 3.Proposed analyses: Two-tailed t tests and logistic regression will be used to determine if there are any significant differences.

Conditions

Hemophilia

Keywords

hemophilia; joint health; motor development; motor proficiency

Outcome Measures

Primary Outcomes (1)

• Motor Proficiency

  Motor proficiency of children and young adults with hemophilia compared to age-matched standardized norms

  At point of testing

Secondary Outcomes (1)

• Joint health using Hemophilia Joint Health Score (HJHS)

  at point of testing

Study Arms (2)

Control

Normative data from standardized assessment

Hemophilia

Persons aged 4-21 with any severity of hemophilia A or B

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Patient's home

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bethany Sloane DPT,PCS, Assistant Professor

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: October 31, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (2)