Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/6/2019 |
| Start Date: | August 28, 2008 |
| End Date: | April 7, 2017 |
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.
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.
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 and/or 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 and/or precision of physical medicine and rehabilitation
assessment equipment, devices and clinical evaluations of impairment, disability, and/or
function.
Outcome Measures
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.
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.
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 and/or precision of physical medicine and rehabilitation
assessment equipment, devices and clinical evaluations of impairment, disability, and/or
function.
Outcome Measures
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.
- INCLUSION CRITERIA:
Inclusion criteria for subjects with disabilities
To participate in projects in this study, subjects with disabilities must:
- have a disability appropriate to the measure being assessed
- be clinically stable and medically able to tolerate the measure to be evaluated in a
specific project in which they are to be enrolled
- be an adult able to give informed consent or, if a minor, have a parent/guardian able
to provide informed consent
- be at least 2 years of age, with no upper age limit
Inclusion criteria for healthy volunteers
To participate in projects in this study, healthy volunteers must:
- be an adult able to provide informed consent or, if a minor, have a parent/guardian
able to provide informed consent
- be in good general health and have no disability
- be able medically able to tolerate the measure to be evaluated in the specific project
in which they are to be enrolled
- be at least 2 years of age, with no upper age limit
EXCLUSION CRITERIA:
Exclusion criteria for subjects with disabilities
- Have limitations relating to their disability that could result in pain or injury on
attempt to use the device or participate in the measure being evaluated in the
specific project in the study
- Are unable to understand the instructions required to safely use the device or
participate in the measure being evaluated
- Have a medical or other device in or on their body which may interfere the research
assessments.
- Have a medical or other device in or on their body that places them at increased risk
from use of any device to be evaluated, based on manufacturer s recommendations or
accepted medical literature
- Have any medical condition which contraindicates use of the specific device to be
evaluated, based on manufacturer s recommendations or accepted medical literature.
Exclusion criteria for healthy volunteers
- Are discovered to have a previously undiagnosed impairment or disability in the domain
to be evaluated by the device or measure to be used in the specific project in the
study
- Are unable to understand the instructions required to safely use the device or
participate in the measure being evaluated.
- Have a medical or other device in or on their body which may interfere the research
assessments.
- Have a medical or other device in or on their body that places them at increased risk
from use of any device to be evaluated, based on manufacturer s recommendations or
accepted medical literature
- Have any medical condition which contraindicates use of the specific device to be
evaluated, based on manufacturer s recommendations or accepted medical literature
- RMD special volunteers, employees and contractors will not be able to participate in
this protocol.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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