NCT00051857

Brief Summary

This study will use magnetic resonance imaging (MRI) and ultrasound images to study how muscles, tendons, and bones work together to cause motion. The procedure is one of several tools being developed to characterize normal and impaired musculoskeletal function, with the goal of developing improved methods of diagnosis and treatment of movement disorders. Healthy normal volunteers must be age 5 to unlimited, with or without joint impairment, may be eligible for this study. Volunteers with joint impairment may not have serious injury to the joint being studied, previous surgery on the joint being studied, or extreme pain at the joint being studied. MRI uses a strong magnet and radio waves to create images of the inside of the body. The subject lies on a long narrow couch inside a metal cylinder (the scanner) for up to 3 hours while the scanner gathers data. Earplugs are worn to muffle loud noises caused by electrical switching of radiofrequency circuits used in the scanning process. A special pad or tube may be placed over or around the region being scanned to improve the quality of the data. The subject will be asked to repeatedly move a specific joint, such as the knee, for brief periods, usually less than 5 minutes. The subject can communicate via intercom with the person performing the study at all times during the procedure, and may request to stop the study at any time.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

March 5, 2003

Completed
Last Updated

April 14, 2026

Status Verified

January 23, 2026

First QC Date

January 16, 2003

Last Update Submit

April 11, 2026

Conditions

Keywords

Patello-FemoralKneeMotionMRIKinematicsNatural History

Outcome Measures

Primary Outcomes (1)

  • Dynamic MRI measures of in vivo tissue velocity, bone and muscle, during dynamic tasks of knee flexion/extension

    MRI techniques to non-invasively measure the 3D in vivo musculoskeletal kinematics, bone shapes, and muscle-tendon lengths in the joints of normal volunteers and healthy volunteers with specific joint impairments.

    End of study

Secondary Outcomes (1)

  • B-mode ultra-sound of muscles and bones that compose the knee joint

    End of study

Study Arms (2)

1/Healthy Controls

Subjects 5 years old and up with musculoskeletal impairment, pathology, or variant.

2/Healthy Volunteers

Subjects 5 years old and up without musculoskeletal impairment, pathology, or variant.

Eligibility Criteria

Age5 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants will be primarily recruited from the greater Washington DC area.

You may qualify if:

  • Affected Participants:
  • Must be between the ages of 5-95 years.
  • Minors \< 18 years of age, they must be capable of providing assent (verbal or written) with parental or legal guardian permissions obtained.
  • Adults 18 \>= years of age, they must be able to provide informed consent.
  • Have the presence of a bone, muscle, soft tissue, connective tissue injury, impairment or related muscular skeletal system pathology.
  • Ability to have an MRI Scan.
  • Healthy Volunteer Participants
  • Must be between the ages of 5-95 years.
  • Minors \< 18 years of age, they must be capable of providing assent (verbal or written) with parental or legal guardian permissions obtained.
  • Adults 18 \>= years of age, they must be able to provide informed consent.
  • Ability to have an MRI Scan.

You may not qualify if:

  • Affected Participants:
  • For the MR imaging portion of this study, all participants must complete the NIH Diagnostic Radiology screening questionnaire. If any potential contraindication is found, either the volunteer s doctor (with knowledge of the potential contraindication) or the radiology department at the NIH will be contacted to determine if the potential contraindication would exclude them from the specific MR scans being proposed.
  • Healthy Volunteer Participants
  • Any relevant medical problems
  • Clinical signs of an impairment in the joint/limb being studied.
  • Any serious injury to the joint/limb being studied, previous surgery on the joint/limb being studied or extreme pain at the joint/limb being studied.
  • Neurologic Pathology affecting the muscular skeletal system
  • For the MR imaging portion of this study, all participants must complete the NIH Diagnostic Radiology screening questionnaire. If any potential contraindication is found, either the volunteer s doctor (with knowledge of the potential contraindication) or the radiology department at the NIH will be contacted to determine if the potential contraindication would exclude them from the specific MR scans being proposed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Congenital AbnormalitiesPatellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Frances T Gavelli, Ph.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances T Gavelli, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2003

First Posted

January 17, 2003

Study Start

March 5, 2003

Last Updated

April 14, 2026

Record last verified: 2026-01-23

Data Sharing

IPD Sharing
Will share

If other investigators wish to use these data, IRB approval will be sought prior to any data sharing. Data sharing will be done under a waiver of informed consent if (1) the previously signed consent form lacked data sharing information or (2) the consent form contained this information and the participant did not ask that his/her data not be shared. Waiver of consent meets the criteria set out in 45 CFR 46.116(d):@@@@@@@@@@@@The research and data sharing involves no more than minimal risk to the subjects.@@@@@@@@@@@@The waiver or alteration will not adversely affect the rights and welfare of the subjects. Data and samples will have personally identifying information removed.@@@@@@@@@@@@The research could not practicably be carried out without the waiver or alteration.@@@@@@@@@@@@Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Shared Documents
CSR
Time Frame
Data will be shared through data sharing agreements.@@@@@@@@@@@@The start and end date will be determined by the data sharing agreement.
Access Criteria
Data will be shared stripped of PII and with IRB approval.

Locations