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Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities

Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00747955
Enrollment
29
Registered
2008-09-08
Start date
2008-08-28
Completion date
2017-04-07
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Human Performance, Physical Disability, Functional Outcome Measures, Health Volunteer, HV

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.

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 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.

Interventions

None listed

Sponsors

National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
To evaluate use of clinical assessments/equipmentOngoing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026