Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00747955
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2008-09-05
Brief Title:
Evaluation of Assessments of Motor Performance Physical Impairments and Functional Abilities
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Assessments of Motor Performance Physical Impairments and Functional Abilities
Status:
TERMINATED
Status Verified Date:
2017-04-07
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 evaluate new assessment tools and equipment and new ways of using existing tools and equipment in the NIH Clinical Center s Rehabilitation Medicine Department in order to maximize patients function The Department assesses and treats NIH patients with chronic pain problems in walking or getting around activities of daily living performing tasks needed for jobs or hobbies communicating and chewing and swallowing
Children and adults of all ages with disabilities and healthy normal volunteers may be eligible for this study
The following kinds of assessments are evaluated in this study
Assessments of Impairments
Impairments are problems such as loss of movement weakness or loss of sensation Assessments may include measurements of range of motion strength sensation pain joint stability or mobility joint angles limb and girth gait exercise tolerance stamina or ultrasound imaging of muscle and swallowing function
Assessments of Function and Performance
Functional and performance assessments look at how well subjects perform actions such as walking or getting around dressing or preparing meals They may include evaluations of activities of daily living leisure activities fatigue vocational activity school activity coping skills and quality of life The assessments may be done by questionnaires or interviews and by watching subjects perform the activities
Assessments of Treatment Techniques
Treatment techniques are assessed by evaluating methods and equipment used to treat patients with impairments or problems with function They may evaluate for example the use of heat cold strengthening exercises fitness exercises TENS units splinting and orthotics or shoe modifications
Children and adults of all ages with disabilities and healthy normal volunteers may be eligible for this study
The following kinds of assessments are evaluated in this study
Assessments of Impairments
Impairments are problems such as loss of movement weakness or loss of sensation Assessments may include measurements of range of motion strength sensation pain joint stability or mobility joint angles limb and girth gait exercise tolerance stamina or ultrasound imaging of muscle and swallowing function
Assessments of Function and Performance
Functional and performance assessments look at how well subjects perform actions such as walking or getting around dressing or preparing meals They may include evaluations of activities of daily living leisure activities fatigue vocational activity school activity coping skills and quality of life The assessments may be done by questionnaires or interviews and by watching subjects perform the activities
Assessments of Treatment Techniques
Treatment techniques are assessed by evaluating methods and equipment used to treat patients with impairments or problems with function They may evaluate for example the use of heat cold strengthening exercises fitness exercises TENS units splinting and orthotics or shoe modifications
Detailed Description:
Objective
The objective of the protocol is to provide framework in which clinicians in the Department of Rehabilitation Medicine RMD can serve the clinical needs of patients and the intramural clinical research needs of NIH investigators by maintaining state of the art expertise in the functional assessment of persons with disabilities and investigating new equipment methodologies andor techniques for functional assessment
Study Population
We intend to study a total of 500 healthy volunteers and 500 subjects with disabilities including those enrolled in NIH intramural research protocols
Design
The study will consist of individual projects designed designed by RMD staff including one or more of the associate investigators The individual projects will be relatively small and designed to test the reliability reproducibility efficiency feasibility sensitivity specificity tolerability validity andor precision of physical medicine and rehabilitation assessment equipment devices and clinical evaluations of impairment disability andor function
Outcome Measures
The specific outcome measures will be chosen to meet the goals of the individual project and will generally include one or more of the following
i Subjective assessment by the participant of the test device or evaluation based on written evaluation tools
ii Comparisons to established evaluations or equipment designed to assess similar areas of function including concurrent validity analyses
iii Subjective assessment by clinicians using the test device or evaluation based on written evaluation tools
iv Feasibility assessments including the time required for participants to perform tests time for clinicians to evaluate the results of the tests andor prepare reports of the results of tests
v Assessments of reliability andor stability of the technique used including statistical tests of coefficients of variability
vi Assessments of tolerance of tests including measures such as vital signs or elements of a physical examination
The objective of the protocol is to provide framework in which clinicians in the Department of Rehabilitation Medicine RMD can serve the clinical needs of patients and the intramural clinical research needs of NIH investigators by maintaining state of the art expertise in the functional assessment of persons with disabilities and investigating new equipment methodologies andor techniques for functional assessment
Study Population
We intend to study a total of 500 healthy volunteers and 500 subjects with disabilities including those enrolled in NIH intramural research protocols
Design
The study will consist of individual projects designed designed by RMD staff including one or more of the associate investigators The individual projects will be relatively small and designed to test the reliability reproducibility efficiency feasibility sensitivity specificity tolerability validity andor precision of physical medicine and rehabilitation assessment equipment devices and clinical evaluations of impairment disability andor function
Outcome Measures
The specific outcome measures will be chosen to meet the goals of the individual project and will generally include one or more of the following
i Subjective assessment by the participant of the test device or evaluation based on written evaluation tools
ii Comparisons to established evaluations or equipment designed to assess similar areas of function including concurrent validity analyses
iii Subjective assessment by clinicians using the test device or evaluation based on written evaluation tools
iv Feasibility assessments including the time required for participants to perform tests time for clinicians to evaluate the results of the tests andor prepare reports of the results of tests
v Assessments of reliability andor stability of the technique used including statistical tests of coefficients of variability
vi Assessments of tolerance of tests including measures such as vital signs or elements of a physical examination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 08-CC-0205 | None | None | None |