Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Movement Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00001252
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date November 3, 1999
First Posted Date November 4, 1999
Last Update Posted Date April 11, 2019
Study Start Date July 5, 1990
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00001252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Human Movement Database
Official Title A Rigid Body Database on Human Movement
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.

Detailed Description

The purpose of this study is to develop a database of normative and adaptive control strategies for human motion. Up to 900 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.

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 device such as the WalkAide may be used in patients who have some dysfunction in their lower extremities. Only persons with central nervous system injuries who have a foot drop gait pattern will be given the opportunity to use this device for 3-6 months. The WalkAide is worn below the knee and delivers individually programmed ES to aid in muscle function of the 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Normal/healthy volunteers and volunteers with impairments of the neuromusculoskeletal system. Subjects will be evenly distributed between males and females.
Condition
  • Healthy
  • Movement Disorder
Intervention Not Provided
Study Groups/Cohorts
  • Healthy Volunteers
    Normal/healthy volunteers
  • Patients
    Volunteers with impairments of the neuromusculoskeletal system.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 13, 2015)
999999999
Original Enrollment
 (submitted: June 23, 2005)
500
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Sara F Sadeghi (301) 451-7529 sara.sadeghi@nih.gov
Contact: Diane L Damiano, Ph.D. (301) 451-7544 damianod@cc.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001252
Other Study ID Numbers 900168
90-CC-0168
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC)
Study Sponsor National Institutes of Health Clinical Center (CC)
Collaborators Not Provided
Investigators
Principal Investigator: Diane L Damiano, Ph.D. National Institutes of Health Clinical Center (CC)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date November 27, 2018