MEDICAL REHABILITATION RESEARCH

NIH GUIDE, Volume 21, Number 7, February 21, 1992



PA NUMBER: PA-92-42



P.T. 34



Keywords:

  Rehabilitation/Therapy, Emotional 

  Rehabilitation/Therapy, Occupation 

  Rehabilitation/Therapy, Physical 

  Pathophysiology 

  Prosthetic Devices (General) 



National Institute of Child Health and Human Development



PURPOSE



The National Center for Medical Rehabilitation Research (NCMRR) of the

National Institute of Child Health and Human Development (NICHD)

invites qualified researchers to submit grant applications for research

on restoring, replacing or enhancing the function of children and

adults with disabilities. Medical rehabilitation research is directed

towards restoration and improvement of functional capability lost as a

consequence of injury, disease and congenital disorder.  The mission of

the NCMRR is to improve the ability of medical rehabilitation to

restore or improve function through research on:  (1) functional

problems associated with diminished mobility, (2) body systems response

to lost function, (3) adaptive behavior systems modifications to

functional loss, (4) treatment intervention effectiveness in restoring

function, (5) assistive devices that replace or enhance function, and

(6) outcome measurement systems that provide an integrative method for

tracking functional change over time in many different domains.



This research includes basic science studies related to the

pathophysiologic mechanisms and processes underlying functional loss.

Basic and clinical studies of the physical impairment that reduces

function are included in the science of medical rehabilitation.

Fundamental knowledge of functional development, change in functional

capacity during development, and alteration of functional abilities

post injury or disease is a focal point of medical rehabilitation

research.  The individual's adaptive and maladaptive behavioral

responses to a physical impairment and functional change are the

subject of a wide variety of basic, clinical and applied studies.  The

societal impact, both positive and negative, of how persons with

disabilities adjust to the demands of culture (e.g., family, work,

support systems) and to natural and man-made environmental barriers

frames the outcome success or failure of medical rehabilitation

programs.



These studies of assisted recovery from or adaptation to functional

loss are conducted by researchers from a wide variety of scientific

disciplines such as specialists in physical and rehabilitation medicine

(physiatry), neurology, pediatrics, urology, orthopedics, neurosurgery,

nursing, physical therapy, occupational therapy, rehabilitation

psychology, sociology,  demography, epidemiology, biomedical

engineering, rehabilitation engineering, orthotists, prosthetists, and

other related health professionals.  In addition, the basic sciences

contribute to understanding mechanisms and processes fundamental to

functional recovery.  These disciplines include genetics, molecular

biology, neurosciences, physiological sciences and other physical

sciences.  Both intradisciplinary and interdisciplinary research are

needed and encouraged.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention goals of "Healthy People 2000," a

PHS-led national activity for setting priorities.  This program

announcement, Medical Rehabilitation Research, is related to the

priority areas of nutrition, physical activity and fitness, heart

disease and stroke, cancer, and diabetes and chronic disabling

conditions.  Potential applicants may a copy of "Healthy People 2000"

(Full Report:  No. 017-001-474-0, or Summary Report:  Stock No

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC  20402-9325  (Telephone:

202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic and foreign for-profit and

non-profit organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State or local governments,

and eligible agencies of the Federal government.  Applications from

minority individuals and women are encouraged.  Additional eligibility

requirements must be met for institutional training grants (T32),

fellowships (F32, F33), and career development awards (K series).



MECHANISMS OF SUPPORT



The mechanisms available for support of this program announcement are:

Individual Research  Grants (R01), First Independent Research Support

and Transition (FIRST) Awards (R29), Program Project Grants (PO1),

Research Career Development Awards (K04), The Academic/Teacher Awards

(K07), The Clinical Investigator Award (K08), The Physician Scientist

Award (K11), National Research Service Award Institutional Training

Grants (T32), and Individual Fellowships (F32, F33).



RESEARCH OBJECTIVES



Background



Between 35 million and 43 million Americans, or 1 in 7, have a

disability.  Almost four percent of the U.S. population are unable to

carry out the major activity of their age group because of severe

disabilities.  An additional six percent of the population are

restricted in their major activity, and another 4 percent are limited

in other types of activity. The NCMRR provides an opportunity for

scientists to conduct research on the functional changes resulting from

illness, injuries, and developmental processes that begin before birth

and continue until the last stages of life. The emphasis will be on

health-related improvement in human functioning at the

pathophysiological, physical impairment, functional impairment,

disability, and societal impact levels of analysis.  Explicitly

included are studies of the application of new knowledge to the

development of medical, behavioral, psychological, social, and

technological interventions designed to optimize functioning after

impairment.  Research of interest would extend from the molecular level

to the functioning of individuals in their physical and social

environment.



Scope



The NCMRR of the NICHD seeks research project, research training,

fellowship, and research career award grant applications for the study

of medical rehabilitation.  This is not a one-time invitation for

applications, but rather a continuing call for research on this topic.

Many research issues fall within the scope of this announcement.

Basic, clinical, and applied research is encouraged through

intervention strategies, measurement strategies, and the development of

assistive devices to improve the knowledge and understanding of the

medical rehabilitation process (pathophysiology, physical impairment,

functional limitation, disability and societal impact) contributing to

functional loss in the broad and overlapping areas of mobility, body

systems, and behavioral systems.  The following are offered as

illustrations of appropriate topics, but applications are not be

limited to these areas:



A.  MOBILITY ENHANCEMENT RESEARCH IN MEDICAL REHABILITATION



1) Treatment Effectiveness



o  Effectiveness of different treatment interventions for long-term

rehabilitation of patients with mobility problems resulting from

cardiovascular disease, myocardial infarction, stroke, and

hypertension.



o  Studies of the neuroplasticity of the nervous and muscular systems

and whether or not interventions might improve the motor functioning of

individuals with neuromotor deficits.



o  Research on hormonal, neurochemical, and potential pharmacological

agents (such as growth hormone) that might improve the physical

functioning or the mobility of individuals with disabilities.



2) Assessment and Measurement



o  Assessment of the effects of the use of mobility aids (i.e., canes,

wheelchairs, prosthetics, and orthotic devices) on the muscles and

joints.



o  Assessment of the potential physiological and metabolic benefits of

varying the means and modes of mobility for people with impaired

mobility.



o  Identification and quantification of the factors and mechanisms

involved in performing important motor tasks such as walking, ascending

stairs, reaching, sitting, and crouching.



o  Improving the analytical tools for evaluating the performance of

work-related tasks.



3) Assistive Devices



o  Development of mechanical and electrical devices that can assist

individuals with physical disabilities to control their environment,

including prosthetic and orthotic equipment, mobility enhancement

(wheelchairs, walkers, safety equipment for transportation vehicles),

remote control of home and work place appliances or tools, and

recreational equipment for use in family, school, and community

settings.



o  Development and testing of devices and/or techniques designed to

teach, supplement, replace or restore communicative and language

functions (e.g., gesturing, listening, speaking, reading, and writing)

of individuals with physical disabilities including alternative forms

of communication (e.g., computer-assisted speech output, speech

substitution), and/or environmental control systems for home, school,

and work.



o  Development of devices and techniques for the mechanical testing of

tissue properties under physiologically representative conditions.



o  Evaluation of the utility, functional impacts, and dependability of

assistive devices.



B.  BEHAVIORAL SYSTEMS RESEARCH IN MEDICAL REHABILITATION



1) Treatment Effectiveness



o  Development of skill-training and educational program products and

therapeutic techniques that supplement, replace, or restore the

functional social, cognitive, adaptive, and motor abilities of

individuals who are physically disabled.



o  Development of:  behavioral techniques for improvement of cognitive

function (e.g., academic training), motor skills (e.g., mobility

difficulties, bowel and bladder control, feeding, and dressing), the

decrease or elimination of destructive behaviors (e.g., self abuse,

aggression, hyperactivity) for individuals with disabilities.



o  Studies of the differential between the functional capacity of older

adults with disabilities and their actual level of performance.



2) Assessment and Measurement



o  Development of data collection and surveillance systems necessary to

generate epidemiologically sound evidence of the incidence and

prevalence of impairments, functional changes, and disabilities in

different societal contexts, and the conduct of such studies.



o  Development and testing of theoretical formulations of the

determinants of impairments, functional changes, and disabilities and

the progression leading from impairment to societal impact.



o  Assessments of patterns and models of care in terms of their impact

on the quality of life of people with disabilities.



o  Rehabilitation assessment of persons with disabilities who are

losing function due to the aging process.



3) Assistive Devices



o  Development and testing of software programs for computer- assisted

instruction, measurement, and assessment of cognitive, vocational, and

social skill acquisition for children and adults with physical

disabilities.



C.  BODY SYSTEMS RESEARCH IN MEDICAL REHABILITATION



1) Treatment Effectiveness



o  Methods to stimulate bone and soft-tissue growth in prosthetic

devices.



o  Rehabilitation research in cancer survivors such as improving

treatment techniques for breast reconstruction and dealing with

dysfunctions associated with breast cancer therapies (behavioral and

psychological problems, vaginal dryness, hot flashes, lymphedema, and

shoulder dysfunction); treatments of sensory or functional deficits

induced by cancer treatments.



o  Clinical intervention effectiveness in attempts to prevent or

remediate adverse long-term effects of kidney transplantation, e.g.,

multiple organ effects, behavioral changes, vocational and social

effects.



o  Rehabilitation of neurophysiological dysfunction including

investigation of therapies that might reduce the extent of neurologic

damage caused by disease or injury, induce functional plasticity and

enhance restoration of function.



o  Medical rehabilitation intervention effectiveness for people with

chronic lung disease.



o  Effectiveness of interventions designed to prevent or remediate the

adverse long-term physical, behavioral, and social effects of asthma.



o  Treatment interventions designed to improve rehabilitation of

musculoskeletal disorders.



o  Treatments to maintain and improve integumentary integrity.



2) Assessment and Measurement



o  Assessment and measurement of joint mechanics and pathophysiology,

musculoskeletal physiology and plasticity, interaction of

musculoskeletal impairments, and the mechanisms governing muscle and

bone development in the presence of normal and abnormal neural

function.



o  Development of clinical tools for the quantitative assessment of

muscle function, mobility, and postural control.



o  Development of quantitative measures for assessing and comparing the

functional capacity to carry out routine tasks and the level of

performance achieved in doing so.



o  Development of procedures and standardized protocols for determining

sites of fatigue in the neuromotor systems in people with and without

impairments and disabilities.



3) Assistive Devices



o  Devices to improve measurement of joint mechanics and

pathophysiology, musculoskeletal physiology and plasticity, interaction

of musculoskeletal impairments, and the mechanisms governing muscle and

bone development in the presence of normal and abnormal neural

function.



o  Development of durable waterproof, life-like cosmesis and

alternative prosthetic covers.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



National Institutes of Health (NIH) policy is that applicants for NIH

clinical research grants will be required to include minorities and

women in study populations so that research findings can be of benefit

to all persons at risk of the disease, disorder or condition under

study.  Special emphasis should be placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

that disproportionately affect them.  This policy is intended to apply

to males and females of all ages.  If women or minorities are excluded

or inadequately represented in clinical research, particularly in

proposed population-based studies, a clear compelling rationale should

be provided.



The composition of the proposed study population must be described in

terms of gender and racial or ethnic group together with a rationale

for its choice.  In addition gender and racial or ethnic issues should

be addressed in developing a research design and sample size

appropriate for the scientific objectives of the study.  This

information should be included on the grant application form PHS 398 in

Section 2, A-D of the research plan and summarized in Section 2, E,

(Human Subjects).



Applicants are urged to carefully assess the feasibility of including

the broadest possible representation of minority groups.  However, NIH

recognizes that it may not be feasible or appropriate in all research

projects to include representation of the full array of United States

racial or ethnic minority populations (i.e., Native Americans

(including American Indians or Alaskan Natives), Asian/Pacific

Islanders, Blacks, Hispanics).  The rationale for studies on single

minority population groups should be provided.



For the purpose of this policy, clinical research includes human

biomedical and behavioral studies on etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissue from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, applicants

must discuss the relevance of research involving foreign population

groups to the United States' populations, including minorities.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed and the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in

assigning the priority score to the application.



All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.



APPLICATION PROCEDURES



Applicants are to use the research project application form PHS 398

(revised 9/91), for the R01, R29, P01, K04, K07, K08, K11 and T32

applications.  On line  2 (Response to Specific Program announcement)

on the face page of the application, type: "Medical Rehabilitation

Research, PA-92-42."



Applicants are advised also to review the appropriate guidelines  for

the various funding mechanisms for unique features of each mechanism:

First Independent Research Support and Transition (FIRST) Award (R29),

September 23, 1991; NIH Research Career Development Award (K04), June

1991; Clinical Investigator Award (K08), October 1991;  Physician

Scientist Award (K11), June 1991; and National Research Service Awards

Institutional Training Grants (T32), October 1990.  These publications

are available at the applicant's institutional Application Control

Office and from the Office of Grants Inquiries, Division of Research

Grants, NIH (telephone 301-496-7441).



Because the PHS 398 form is designed primarily for the traditional R01

application, several sections, outlined on the instruction sheet, must

be modified and expanded to provide the additional information required

for a P01 or K07.  Applicants for the P01 should use the application

format as described in the NICHD pamphlet, Program Project Guidelines,

1991, that may be obtained from the contacts listed under INQUIRIES.

Applicants for the K07 should also obtain guidance from the contacts

listed under INQUIRIES.



Fellowship applications (F32 and F33) must be submitted on the

Application for Public Health Service Individual Service Award (PHS

416-1).  If the applicant is a noncitizen, a notarized statement of

permanent residence must accompany the application.  Applicants must

submit with the application at least three letters of reference.



Receipt dates for Research Project Grants, Career Development Award,

and FIRST Award applications are February 1, June 1, and October 1 of

each year.  The individual National Research Service Award applications

are accepted January 10, May 10, and September 10.  Institutional

training grant applications are accepted once each year, January 10.



If using the PHS 398, submit the original application and six copies to

the following address.  If using the PHS 416, submit the original

application and two copies to:



Grant Application Receipt Office

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda,  MD 20892**



REVIEW PROCEDURES



All applications will be received by the Division of Research Grants

(DRG), NIH.  Research project grant (R01 and R29) applications,

fellowships (F32, F33) and research career development awards (K04)

will be reviewed for scientific and technical merit by an appropriate

study section in the Division of Research Grants.  All other

applications will be reviewed by an appropriate institute review group.

The initial review for scientific and technical merit will be by a

review group composed mostly of nonfederal scientific consultants

(study section).  Secondary review will be by the appropriate national

advisory council.  The review criteria customarily employed by the NIH

PHS for applications will prevail.  The specific criteria for each

mechanism are described fully in the publications listed in APPLICATION

PROCEDURES.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The following will be considered in making funding

decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement



INQUIRIES



Researchers considering an application in response to this announcement

are encouraged to discuss the project and the range of grant mechanisms

available with NCMRR staff listed below in advance of formal

submission.



Direct inquiries regarding programmatic issues to:



Louis A. Quatrano, Ph.D.

Chief, Applied Medical Rehabilitation Research Branch

National Center for Medical Rehabilitation Research

National Institute of Child Health and Human Development

Executive Plaza South, Room 450W

6120 Executive Boulevard

Rockville, MD  20852

Telephone:  (301) 402-2242



or



Danuta Krotoski, Ph.D.

Chief, Basic Medical Rehabilitation Research Branch

National Center for Medical Rehabilitation Research

National Institute of Child Health and Human Development

Executive Plaza South, Room 450W

6120 Executive Boulevard

Rockville, MD  20852

Telephone:  (301) 402-2242



For fiscal and administrative inquires regarding this announcement,

potential applicants may write or call:



E. Douglas Shawver

Office of Grants and Contracts

National Institute of Child Health and Human Development

Executive Plaza North, Room 501

6130 Executive Boulevard

Rockville Pike, MD  20892

Telephone:  (301) 496-1303



AUTHORITY AND REGULATION



This program is described in the Catalog of Federal Domestic Assistance

No. 93.929, Medical Rehabilitation Research.  Awards are made under

authorization of the Public Health Service Act, Title IV, Part A

(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and

285) and administered under PHS grants policies and Federal Regulations

42 CFR 52 and 45 CFR Part 74.  This program is not subject to the

intergovernmental review requirements of Executive Order 12372 or

Health Systems Agency review.



.

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