Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities
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|ClinicalTrials.gov Identifier: NCT00747955|
Recruitment Status : Terminated
First Posted : September 8, 2008
Last Update Posted : June 21, 2018
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.
|Condition or disease|
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 and/or techniques for functional assessment.
We intend to study a total of 500 healthy volunteers and 500 subjects with disabilities, including those enrolled in NIH intramural research protocols.
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 and/or precision of physical medicine and rehabilitation assessment equipment, devices and clinical evaluations of impairment, disability, and/or function.
The specific outcome measure(s) 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, and/or prepare reports of the results of tests.
v. Assessments of reliability and/or 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 Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities|
|Study Start Date :||August 28, 2008|
|Study Completion Date :||April 7, 2017|
- To evaluate use of clinical assessments/equipment [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747955
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Scott M Paul, M.D.||National Institutes of Health Clinical Center (CC)|