RESTITUTION OF AMBULATION FOLLOWING DISABILITY FROM NEUROLOGICALDISORDERS



NIH Guide, Volume 22, Number 17, April 30, 1993



PA NUMBER:  PA-93-079



P.T. 34



Keywords:

  Rehabilitation/Therapy, Physical 

  Neurological Disorders 

  Injury 

  Nervous System 



National Institute of Neurological Disorders and Stroke

National Institute of Child Health and Human Development



PURPOSE



The National Institute of Neurological Disorders and Stroke (NINDS) and

the National Institute of Child Health and Human Development (NICHD),

invite research grant applications for support of research on the

restitution of ambulation following disability from neurological

disorders or injury.



Applications covering a broad range of activities in the neurological

sciences from clinical research to fundamental neuroscience research

are encouraged.  Regardless of approach, all proposed research

activities should share the common theme of restoring ambulatory

function in the presence of dysfunction of the central or peripheral

nervous system.  This type of solicitation is issued to encourage

investigator-initiated research projects in areas of special

programmatic interest to the National Institutes of Health (NIH).



HEALTHY PEOPLE 2000



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

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This Program

Announcement (PA), Restitution of Ambulation Following Disability From

Neurological Disorders, is related to the priority area of chronic

disabling conditions.  Potential applicants may obtain a copy of

"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or

"Healthy People 2000" (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 foreign and domestic, for-profit and

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

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal government.

Applications from minority individuals and women are encouraged.

Foreign institutions are not eligible to apply for career awards (K04,

K08) or First Independent Research Support and Transition (FIRST) (R29)

awards and program projects (P01).  Applicants for K04 and K08 awards

must be U.S. citizens or resident aliens.



MECHANISM OF SUPPORT



The support mechanisms for this research will be the individual

research grant (RO1), the FIRST award (R29), Research Career

Development Award (K04), Clinical Investigator Award (K08), and the

program project grant (P01).  The number of awards to be made is

dependent upon receipt of a sufficient number of applications of high

scientific merit and upon availability of funds.



RESEARCH OBJECTIVES



Summary



The NINDS is the principal NIH component for support of basic and

clinical research on neurological disorders and their prevention,

diagnosis, treatment, and rehabilitation.



The National Center for Medical Rehabilitation Research at the NICHD

serves as the principal NIH focus of research support that will lead to

new approaches for the replacement, enhancement or restoration of

function in persons with physical disabilities resulting from birth

defect, injury, disease or the aging process.  Because of a lack of

effective restorative therapies, the clinical approach to

rehabilitation has often focused on substitution.  For example, a

walker or wheel chair can substitute for inadequate lower extremity

muscle strength or control.  This PA encourages research directed at

rehabilitation through restitution or enhancement of function in

patients disabled by neurological disorders or by injury to the nervous

system during both the acute and chronic phases.



Disability in the form of a loss of the ability to ambulate can follow

many common neurological and neuromuscular diseases and disorders or

traumatic injuries.  For example, approximately 250,000 persons are

disabled by stroke in the United States each year.  Many of these

individuals are either unable to walk or walk with great difficulty as

a result of inadequate or untimely muscle activity.  Other individuals

suffering from spinal cord injury, head injury, cerebral palsy,

Parkinson's disease, multiple sclerosis, and other neurological

conditions are similarly affected.



Achieving the goal of rehabilitation through restitution or improvement

of function in patients disabled by neurological disorders will require

fundamental and applied research in many areas.  Potential areas of

research include motor control, sensory systems in motor control,

ambulation, postural control as it relates to gait, and activation,

conditioning and control of weakened or paralyzed muscles.  This PA is

issued to encourage grant applications that cover a range of

investigative approaches from basic neurosciences to feasibility

studies of potential clinical applications.



Goals



This PA is issued to encourage and foster investigator-initiated

applied, basic, and clinical research on restoration of ambulation

following neurological disability.  Although specific neurological

diseases and disorders are not mentioned in this section, potential

applicants are encouraged to focus their effort in the context of a

specific disorder.  Examples of research objectives appropriate for

inclusion in applications responsive to this program announcement

include:



o  Applied research directed at improving or restoring ambulatory motor

function in neurologically impaired individuals;

o  Applied research directed at improving or restoring cutaneous

sensation and proprioception related to ambulation in neurologically

impaired individuals;

o  Fundamental studies of the neurophysiological foundation of the

control of ambulation and its pathology;

o  Fundamental studies of the neurophysiological foundation of

cutaneous sensation and proprioception, their pathology and their role

in ambulation;

o  Studies of the integration of biomechanics and the motor, sensory

and central nervous systems in gait, standing, and in postural control;

o  Fundamental and applied studies that will characterize the capacity

of both injured and non-injured systems to contribute to the recovery

of ambulatory function; and

o  More accurate and sensitive methods for quantifying functional

impairments after neurological injury or disorder.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH clinical research grants and

cooperative agreements are 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 must be placed on the need for inclusion of minorities

and women in studies of diseases, disorders and conditions which

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 must be

provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information must be included in the form PHS 398 (rev.

9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5,

Human Subjects.  Applicants are urged to assess carefully 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/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 must be provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of 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 tissues 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, the

applicant 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 review will be deferred until the information is provided.



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



Applications are to be submitted on the grant application form PHS 398

(rev. 9/91) and will be accepted on any of the three receipt dates for

research grant applications, February 1, June 1, and October 1.

Application kits are available at most offices of sponsored research

and may be obtained from the Office of Grants Inquiries, Division of

Research Grants, National Institutes of Health, Westwood Building, Room

449, Bethesda, MD 20892, telephone (301) 710-0267.  The title and

number of the announcement must be typed in Section 2a on the face page

of the application.



The original and five copies of the application must be sent or

delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW PROCEDURES



Applications will receive institute and initial review group (IRG)

assignment on the basis of established Public Health Service referral

guidelines.  Applications will be reviewed for scientific and technical

merit according to standard PHS referral guidelines.  Following IRG

review, the applications will receive a second-level review by an

appropriate Council/Board.  Applications will compete for available

funds with all other approved applications assigned to the institute.



REVIEW CRITERIA



The standard review criteria will be used to assess the scientific

merit of applications.  The IRG will be reviewing the adequacy of

protection of human subjects, the humane care of animals, and biosafety

conditions.  In clinical research studies, reviewers also will be

evaluating the adequacy of the inclusion of women and minorities in the

study populations.



AWARD CRITERIA



Applications will compete for available funds with all other

applications.  The following will be considered when making funding

decisions:



o  quality of the proposed projects as determined by peer review

o  availability of funds

o  program balance among research areas of the announcement



INQUIRIES



Written and telephone inquiries are encourages.  the opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Dr. William Heetderks

Division of Fundamental Neurosciences

National Institute of Neurological Disorders and Stroke

Federal Building, Room 916

Bethesda, MD  20892

Telephone:  (301) 496-5745

Internet:  w2h@cu.nih.gov



Dr. Danuta Krotoski

National Center for Medical Rehabilitation Research

National Institute of Child Health and Human Development

Executive Plaza North, Room 450

Bethesda, MD  20892

Telephone:  (301) 402-2242

Bitnet:  d2k@NIHCU



For fiscal and administrative matters contact:



Ms. Kathleen Howe

National Institute of Neurological Disorders and Stroke

Federal Building, Room 1004

Bethesda, MD  20892

Telephone:  (301) 496-9231



Ms. Mary Ellen Colvin



Office of Grants and Contracts

National Institute of Child Health and Human Development

6100 Executive Boulevard, Room 8A17F

Bethesda, MD  20892

Telephone:  (301) 496-1303



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.929 - Medical Rehabilitation Research, 93.854 - Biological Basis

Research in Neurosciences, and 93.853 - Clinical Research related to

Neurological Disorders.  Grants will be awarded under the authority of

the Public Health Service Act, Title III, Section 301 (Public Law

78-410, as amended; 42 USC 241) and administered under PHS grants

policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74.

This program is not subject to the intergovernmental review

requirements of Executive Order 12372 or a Health Systems Agency

review.



.

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