Human Movement Database

Sponsor
National Institutes of Health Clinical Center (CC) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT00001252
Collaborator
(none)
7,500
1

Study Details

Study Description

Brief Summary

This study will collect information on the different ways people control limb and body movements. This information will be used to develop a database on normal movements and adaptive movements of people who have diseases that affect the way they move. The database will serve as a tool to improve diagnosis and treatment of patients with movement-related problems.

Volunteers of all ages who have normal movement patterns or who have developed different ways to perform movement tasks may be eligible for this study. A physician or physical therapist will screen candidates to determine their strength, flexibility and range of motion of joints.

Participants will be asked to perform movements such as walking, walking up or down stairs, standing quietly or reaching for an object or using treadmill. For the test, the arms and legs are wrapped with a soft, rubber-like material to which small plastic reflective balls are attached. A piece of firm material called a shell may be attached to the rubber sleeves or other areas of the body. Then the volunteer performs the specified task several times while special cameras record the movement. These cameras will record the positions of the reflective balls during movement and may show the person s face or body. Electrical activity in the muscles also may be measured, using small metal electrodes attached to the surface of the skin with an adhesive bandage.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of this study is to develop a database of normative and adaptive control strategies for human motion. Volunteers will serve as subjects after they complete a neuromusculoskeletal screening exam. Subjects will be asked to perform one or more tasks related to the execution of activities of daily living such as: walking on the ground, walking on a treadmill, quiet and perturbed standing, stair ascent and descent, turning and jumping, cycling, elliptical training, and isolated upper and lower extremity limb movements or trunk movements. The subjects movement patterns will be recorded using a three-dimensional motion tracking system. Motion data will be analyzed using a rigid body six degree-of-freedom approach when applicable. Temporal/spatial, kinematic, kinetic, and surface electromyographic variables will be collected and calculated. When only temporal-spatial parameters are of interest, an instrumented portable walkway system may be used.

    Many factors affect the ability to move. The ones we are mainly interested in investigating include muscle weakness, spasticity, and dynamic balance. To quantify strength or spasticity, a force transducer is needed such as a Biodex isokinetic dynamometer which is a standard rehabilitation assessment and training device, or a more simple handheld dynamometer can be used that the person presses against as force is recorded. For the spasticity tests, a person or a machine such as the Biodex moves a joint through an arc of motion (e.g. elbow, knee, or ankle) at a range of speeds from 5-240 degrees per second while resistance to motion is being recorded or graded subjectively. EMG and joint position may be collected simultaneously during the passive movements. The dynamic balance tests will be performed on a force plate or using a clinical balance testing device, the Equitest, by Neurcom. To determine if electrical stimulation (ES) improves limb movement, walking, and balance, a FDA-cleared device (LG-8TM FDA 510K 4 Channel TENS/EMS Unit, LGmedsupply.com) may be used in patients who have some gait dysfunction in their lower extremities. Only persons with central nervous system injuries who have an abnormal gait pattern will be given the opportunity to use this device. The device delivers individually programmed ES to aid in muscle function of the hip, knee or ankle.

    Patient groups will be identified clinically or statistically. Group means and standard deviations will then be computed. It is hoped the database developed may serve as a tool by which individual patient data may be compared in order to facilitate the diagnosis and optimize the treatment and clinical outcome of patients with movement related problems.

    An over ground harness system may be used for some of the over ground or instrumented gait and balance assessments if there is concern that the patient is too weak or unbalanced and therefore may trip or fall during the activity, or to help facilitate more normal patterns by decreasing the load borne by the trunk and/or legs.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    7500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    A Rigid Body Database on Human Movement
    Actual Study Start Date :
    Mar 13, 1995

    Arms and Interventions

    Arm Intervention/Treatment
    healthy volunteer

    Normal/healthy volunteers

    Impaired volunteer

    volunteers with impairments of the neuromusculoskeletal system.

    Outcome Measures

    Primary Outcome Measures

    1. Gait Kinematics [end of testing]

      Strength and spasticity testing both include torque or force measurements as the primary outcomes. Balance testing typically yields the amount, velocity and direction of sway in response to different conditions or perturbations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • Any volunteer of any age from birth to old age who is deemed medically fit to participate and is willing to provide their informed consent will be included in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institutes of Health Clinical Center (CC)

    Investigators

    • Principal Investigator: Diane L Damiano, Ph.D., National Institutes of Health Clinical Center (CC)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    National Institutes of Health Clinical Center (CC)
    ClinicalTrials.gov Identifier:
    NCT00001252
    Other Study ID Numbers:
    • 900168
    • 90-CC-0168
    First Posted:
    Nov 4, 1999
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Jul 29, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institutes of Health Clinical Center (CC)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2022