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

NCT00747955 | Terminated

• 2 other identifiers: 08020508-CC-0205
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To evaluate use of clinical assessments/equipment

  Ongoing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Study Officials

• Scott M Paul, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: August 28, 2008
• Study Completion: April 7, 2017
• Last Updated: December 17, 2019

Record last verified: 2017-04-07

Locations

US (1)