Healthy VolunteersNCT00747955
Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities
An observational study of Healthy Volunteers, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2008to 7 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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:
- 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.
- 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.
- Conditions
- Healthy Volunteers
- Keywords
- Human Performance, Physical Disability, Functional Outcome Measures, Health Volunteer, HV
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate use of clinical assessments/equipment
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study start28 Aug 2008
- Study completion7 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Scott M Paul, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747955
- Sponsor's protocol ID
- 080205
- Other IDs
- 08-CC-0205
- Status last verified
- 7 Apr 2017
- First submitted
- 5 Sep 2008
- Last updated
- 17 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities
- ClinicalTrials.gov ID
- NCT00747955
- Acronym / sponsor ID
- 080205
- Conditions
- Healthy Volunteers
- Keywords
- Human Performance, Physical Disability, Functional Outcome Measures, Health Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 28 Aug 2008
- Study completion
- 7 Apr 2017
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- be an adult able to provide informed consent or, if a minor, have a parent/guardian able to provide informed consent
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate use of clinical assessments/equipment
Time frame: Ongoing
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott M Paul, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate use of clinical assessments/equipment (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.