Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001252
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
1999-11-03
Brief Title:
Human Movement Database
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Rigid Body Database on Human Movement
Status:
RECRUITING
Status Verified Date:
2024-04-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 from one month old to old age 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
Volunteers from one month old to old age 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 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 Temporalspatial 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 eg 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 TENSEMS Unit LGmedsupplycom 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 andor legs
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 eg 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 TENSEMS Unit LGmedsupplycom 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 andor legs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 90-CC-0168 | None | None | None |