Human Movement Database
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||November 13, 2015|
|Start Date ICMJE||July 1990|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001252 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Human Movement Database|
|Official Title ICMJE||A Rigid Body Database on Human Movement|
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 over the age of 4 who have normal movement patterns or who have developed different ways to perform movement tasks may be eligible for this study. A 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. 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. The cameras only record the positions of the reflective balls during movement, not 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.
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 ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||999999999|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001252|
|Other Study ID Numbers ICMJE||900168, 90-CC-0168|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC)|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP