RESEARCH PAPER

INCLEN Diagnostic Tool for Neuromotor Impairments (INDT-NMI) for

Primary Care Physician: Development and Validation
SHEFFALI GULATI, SATINDER ANEJA, MONICA JUNEJA, SHARMILA MUKHERJEE, VAISHALI DESHMUKH,
DONALD SILBERBERG, VINOD K BHUTANI, JENNIFER M PINTO, MAUREEN DURKIN, POMA TUDU,
RAVINDRA M PANDEY, MKC NAIR, NARENDRA K ARORA AND INCLEN STUDY GROUP*
From the INCLEN TRUST International, New Delhi, India
Correspondence to: Dr Narendra K Arora, Executive Director, The INCLEN Trust International, F1/5, Okhla Industrial Area Phase 1, New Delhi,
India. [email protected]
Received: April 03, 2013; Initial review: July 05, 2013; Accepted: April 22, 2014.

Objectives: To develop and validate a diagnostic tool for use by Results: According to expert evaluation, 171 (37.8%) children
primary care physicians for diagnosing neuro-motor impairment had neuromotor impairments. There were four categories of
among 2-9 year old children in primary care settings. subjects: NMI alone (n=66); NMI+other NDDs (n=105); Other
NDDs without NMI (n=225) and ‘Normal’ group (n=58). Using
Study design: Modified Delphi technique involving national
expert evaluation as gold standard, overall sensitivity of the INDT-
(n=49) and international (n=6) experts was used for development
NMI was 75.4% and specificity was 86.8%. INDT-NMI helped
of INDT-NMI. The tool was then validated through a cross
graduate physicians to correctly classify 86.6% (112/129) children
sectional study.
with NMI into different types (cerebral palsy, neuromotor diseases
Setting: Neurology specialty clinics of three tertiary care pediatric and other NMI). Graduate physicians assigned 40 children (8.8%)
centers in New Delhi, India. as ‘indeterminate’, 38 (95%) of whom had either NDD and/or NMI
Participants: 454 children aged 2-9 years [mean (SD) age: 60.4 and thus merited referral. Misclassification of NMI occurred in
(23.7) mo], selected through systematic random sampling, those with mild changes in muscle tone, dystonia, or ataxia and
underwent assessment for identification and classification of associated NDDs.
neuromotor impairments (NMI). Conclusion: Graduate primary care physicians with a structured
Intervention: All study subjects were first administered INDT- short training can administer the new tool and diagnose NMI in 2-9
NMI (candidate test) by a trained physician followed by expert year old children with high validity. INDT-NMI requires further
assessment for NMI and other neurodevelopment disorders evaluation in actual primary care settings.
(NDD) by team of two pediatric neurologists (Gold standard). Keywords: Cerebral palsy, Disability, Diagnosis, Neuromuscular
disorders, Resource constrained environments.

P
rimary care physicians frequently encounter approach to management and outcome varies
children with neuromotor impairments who significantly [1-3].
have difficulties of movement, posture and
coordination in their day-to-day life. Accompanying Editorials: Pages 607-10.
Neuromotor impairments (NMI) include a continuum of
disorders caused by a wide variety of non-progressive Pediatric neurologists, developmental pediatricians
and progressive conditions that affect body functions, and therapists with expertise in diagnosis and
activities, and quality of life. Cerebral palsy (CP) management must be able to obtain a relevant history and
constitutes the bulk of NMI; progressive acquired or perform focused musculoskeletal, neurologic and
inherited neuromuscular disorders (NMD), and other functional physical examinations to diagnose NMI [4].
NMI (not satisfying the definition of either CP or NMD) The availability and access to such expertise in resource-
have to be considered in differential diagnoses as the constrained environments like India and other

*INCLEN Study Group: Core Group: ALOK THAKKAR, ARUN SINGH, DEVENDRA MISHRA, GAUTAM BIR SINGH, MANJU MEHTA, MANOJA K DAS,

NANDITA BABU, PAUL S S RUSSELL, PRAVEEN SUMAN, RAJESH SAGAR, RAMESH KONANKI, ROHIT SAXENA, SAVITA SAPRA, SUNANDA K REDDY,
TANUJ DADA. Extended Group: AK NISWADE, ARCHISMAN MOHAPATRA, ARTI MARIA, ATUL PRASAD, BC DAS, BHADRESH VYAS, GVS MURTHY,
GOURIE M DEVI, HARIKUMARAN NAIR, JC GUPTA, KK HANDA, LEENA SUMARAJ, MADHURI KULKARNI, MUNEER MASOODI, POONAM NATRAJAN,
RASHMI KUMAR, RASHNA DASS, REMA DEVI, SANDEEP BAVDEKAR, SANTOSH MOHANTY, SARADHA SURESH, SHOBHA SHARMA, SUJATHA S THYAGU,
SUNIL KARANDE, TD SHARMA, VINOD AGGARWAL, ZIA CHAUDHURI.

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developing countries is severely restricted and thus development and validation exercise was conducted from
significantly increases the gaps in identification, and June 2008 to April 2010. Ethical approval was obtained
delivery of specific therapeutic and rehabilitative from INCLEN review board and ethics committees of all
services for NMI [5,6]. Availability of a diagnostic tool the sites.
for use by primary care physicians will considerably
increase access to specific care and rehabilitation of Development of diagnostic tool: Candidate test: As the
children with NMI. Currently no validated tool is first step, a consensus clinical criteria (CCC) for
available for diagnosing NMI among 2-9 year old diagnosing NMI was developed by group of national
children in primary care settings. The demand for such a (n=49) and international (n=6) experts consisting of
tool is further enhanced in the light of recently launched pediatricians, developmental pediatricians, child psy-
Rastriya Bal Swasthya Karyakram (RBSK) wherein chiatrists, pediatric neurologists, pediatric oto-rhino-
diagnosis and management of neuro-developmental laryngologists, community physicians, clinical psycho-
disorders within primary care settings is a core element of logists, special educators, specialist nurses, speech
the program services [7]. therapists, occupational therapists, and social scientists,
for diagnosing NMI through a series of three 2-day work-
To fill this gap, the INCLEN study group developed
shops and web-based discussion using modified Delphi
and validated a diagnostic tool for NMI (INCLEN
method. The CCC was then converted in to a diagnostic
Diagnostic Tool for Neuromotor Impairments: INDT-
tool, INDT-NMI, for use by graduate physicians in
NMI) that employs standardized and uniform diagnostic
primary care settings.
criteria for use in 2-9 year-old children. The tool is meant
to be used by graduate physicians after a structured short
INDT-NMI is based on the definitions and
training in primary care settings.
classification proposed for cerebral palsy [11] along with
METHODS questions to identify neuromuscular disorders (NMD)
and other NMI that do not fit in to definition of either of
Study design: Modified Delphi process for developing
these conditions (for practical reasons and simplification
the tool, and diagnostic test evaluation by cross-sectional
of the diagnostic process at primary level). The INDT-
study design
NMI thus developed comprises of three sections.
The study was part of the INCLEN program to estimate Section-I (Triage questions) consists of four questions to
the burden of Neuro-developmental Disorders (NDDs) in elicit information from the parents/primary caregiver of
2-9 year-old children at five sites across the country. As the child regarding attainment of selected motor
part of the larger study, specific diagnostic tools (for developmental milestones. Section-II (Observations):
autism spectrum disorders [8], attention deficit hyper- Physician makes three observations for assessing hand
activity disorder [9], epilepsy [10] and NMI) were function, gait and muscle weakness. Section-III consists
developed and validated for use by different levels of of six questions, and the operator (graduate physician)
health personnel. INDT-NMI is to be applied by primary does the neurological examination necessary for
care physicians for the diagnosis of NMI. The evaluation confirmation of NMI. Thus final diagnosis of NMI is
of INDT-NMI was conducted on 2-9 year-old children derived through an algorithm based on interpretation of
attending the pediatric neurology outpatient clinic of three sections (i.e. 13 questions/items) and information
three public sector tertiary-care referral centers [All India on age at onset of symptoms, course of the illness and
Institute of Medical Sciences (AIIMS), Lady Hardinge obvious clinical evidence of involvement of spinal cord
Medical College (LHMC), and Maulana Azad Medical (i.e. pilonidal sinus, tuft of hair). This tool requires
College (MAMC)] in New Delhi, India. The pediatric approximately 20-25 minutes for assessing each child.
neurology specialty clinics in these hospitals attract a mix Tool includes specific neurologic examination with
of complex neurology problems referred for diagnosis interpretation but examination of cranial nerves and
and management. Children of either gender in the age sensory neurologic system examination is not included in
group 2-9 years coming for the first time in the pediatric the tool as these are not directly relevant for making
neurology clinics of these hospitals were eligible for diagnosis of NMI. The final diagnosis informs whether
inclusion in the study. Children were excluded from the the case has cerebral palsy (CP), neuromuscular disorders
study if they had poor general condition (e.g. respiratory (NMD), Other NMI (that does not fit in to either CP or
distress requiring supplemental oxygen, peripheral NMD), no NMI or an indeterminate clinical condition.
circulatory collapse, altered sensorium, or requiring care The tool (Web Appendix I) was prepared in English,
in intensive care), were not accompanied by primary translated into Hindi and back translated to English
caregiver, and if care provider refused consent. The tool before the study was undertaken.

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At each of the three institutions, diagnosis of NMI teaching and simulated administration of the tool in five
was established by consensus of two pediatric cases of neuro-motor impairment. The training also
neurologists with expertise in diagnosis and management involved interview skills and techniques of neurological
of children with NMI and other NDDs. The clinical examination of children.
assessment included detailed history and physical
Sample size: We expected four categories of subjects in
examination with access to radiological and other
whom INDT-NMI was to be evaluated: NMI alone, NMI
relevant investigations whenever available.
along with other NDD, Other NDDs without NMI and
Systematic random sampling of the children children without NMI or other NDDs (Normal). Assuming
attending pediatric neurology clinics was followed for sensitivity and specificity of INDT-NMI to be 85% with
enrolment of study subjects. Daily, the principal ±10% precision at 95% confidence level, sample size was
investigator provided two computer-generated random calculated to be 50 subjects in each category of patients.
numbers to the study coordinator in a sealed envelope. To account for 10% drop-outs, it was decided to enroll at
First random number (between 1 and 9) gave the serial least 55 children in each category. The sample size was
number of first child to be recruited in the clinic and calculated using Epi info software [12].
second random number was the nth number of patient Statistical analysis: The data were analyzed using STATA
(between 5 and 15 and represented interval between 10 software. The psychometric properties of INDT-NMI
subjects as they came up in neurology specialty OPD at were calculated against the assessment done by team of
central registration) who was identified for the detailed pediatric neurologists (Gold standard).
evaluation. The identified subjects so enrolled were
assessed for eligibility by site coordinator, and enrolled RESULTS
after obtaining written, informed consent until the final A total of 454 children (mean ± SD age: 60.4 ± 23.7) were
sample size was achieved. If consent or inclusion enrolled from three centers: AIIMS 354; MAMC 46; and
criterion was not achieved or if the child was not a first LHMC 54. The subjects included 308 (68%) boys and
timer attendee, (n+1) th child was enrolled. Subjects were 146 (32%) girls; 40.3% (n=183) were 24-48 month old,
recruited till the desired sample size was obtained in each 43.2% (n=196) were aged between 49-84 months, and
category. 16.5% (n=75) belonged to 85-108 month category.
At each study site, a team of pediatric neurologists (at According to expert evaluation, 66 children had NMI
least two per site) with at least three years of experience in alone (CP=39; NMD 20; other NMI 7), 105 had NMI
the diagnosis and management of children with NMI and with other NDDs (CP 95; NMD 3; other NMI 7) 225 with
other NDDs, one study coordinator and two graduate Other NDDs without NMI, and 58 subjects were normal
physicians (MBBS) undertook the study. Subjects were (without NMI or any other NDD). Thus, 171 (38%)
first administered the INDT-NMI (candidate test) by a children had NMI (CP 134; NMD 23 and other NMI 14)
graduate doctor (MBBS qualified) and later evaluated by and remaining 283 (62.3%) were without NMI. Out of
the expert team of pediatric neurologists (gold standard). 134 children with CP, 95 (70.9%) had one or more co-
The findings of the graduate physician and expert group morbidities like epilepsy, global developmental delay
were separately placed in opaque envelopes, sealed and and intellectual disability.
handed over to the coordinator. Evaluators of one Using INDT-NMI, graduate physicians were able to
category were blinded to the diagnosis of the other group. assign NMI (yes/no) label to 414 subjects: remaining 40
The children were given prescription and instructions for out of 454 (8.8%) subjects were categorized as
additional investigations as required and follow-up by the ‘indeterminate’ (Fig.1). The overall sensitivity of the tool
expert group. After initial assessment, the subjects were was 75.4% (95% CI: 68.0-81.3) and specificity was
not allowed to interact with the graduate physician to 86.6% (95% CI: 82.1-90.1). Out of 129 NMI cases
avoid contamination and influence on the assessment of detected true positive, 112 (86.8%) were correctly
subsequently recruited subjects. classified by INDT-NMI to a specific neuro-motor
impairment type (CP, NMD or other NMI).
A standardized training manual with detailed
instructions for administration of the tool was developed. Table I provides validity of the tool for various
Graduate physicians at each center administered the groups of subjects without taking indeterminate cases in
questionnaire verbatim, questioning the parents in the to consideration. Sensitivity of the tool was between
language they could understand (English or Hindi). These 89.7% and 83.7% for two groups of NMI; while the
individuals were trained during a one-day hands-on specificity among normal children or those with other
structured workshop that included eight hours of didactic NDDs was 96.4% and 91.8%, respectively.

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Study universe: Children attending pediatric neurology clinics at study sites

↓
Every nth child in 2-9 years age group assessed for eligibility

Excluded-17
Refused consent-11
Not accompanied by
primary caregiver-6

No. of enrolled children: 454

↓
Written, informed consent by primary caregiver

↓
Assessment by team of pediatric neurologist (Gold Standard)

↓ ↓
↓ ↓ ↓ ↓
NMI alone NMI +Other NDD Other NDD without No NMI or any
66 105 NMI 225 NDD 58

↓ ↓
Neuromotor Impairment No Neuromotor Impairment
171 283

Administration of INDT-NMI by graduate

physician (MBBS)

↓ ↓ ↓ ↓ ↓ ↓
True Positive False Negative Indeterminate Indeterminate False Positive True Negative
129 (75.4%) 21 (12.3%) 21 (12.3%) 19 (6.7 %) 19 (6.7%) 245 (86.6%)
95% CI: 68.5-81.3 95% CI: 8.2-18.0 95% CI: 8.2-18.0 95% CI: 4.3-10.2 95% CI: 4.3-10.2 95% CI: 82.1-90.1

↓ ↓ ↓ ↓
NMI NMI + Other Other NDD- Normal-2
alone-8 NDD-13 17

NMI: Neuromotor Impairment; Other Neurodevelopmental disability (NDD): include global developmental delay/intellectual
disability, autistic disorder, and attention deficit/hyperactivity disorder, hearing impairment, vision impairment and speech and
language disorders.

FIG. 1 INCLEN Diagnostic Tool for Neuromotor Impairment (INDT –NMI): Subject recruitment and assessment.

The expert (gold standard) diagnostic labels of 40 indeterminate. Twenty-one children (52.5%) had
subjects categorized as ‘indeterminate’ by the INDT- intellectual disability/global development delay. Overall,
NMI were: NMI alone 8; NMI + other NDD 13; NDD out of 40 indeterminate cases, 38 (95%) had other NDDs
other than NMI 17; and Normal (without NMI or any with or without NMI; remaining 2 children were from
NDD) 2. Failure to identify hypotonia, mild spasticity, ‘Normal’ group and had moderate undernutrition.
dystonia and ataxia by the graduate physicians were the
frequent reasons for NMI cases being labeled as False negative cases had hypotonia (4 patients),

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TABLE I PSYCHOMETRIC PROPERTIES OF INCLEN DIAGNOSTIC TOOL FOR NEURO-MOTOR IMPAIRMENT (INDT-NMI)
(Analysis after excluding cases labeled as ‘INDETERMINATE’)*

Categorization as per Neuromotor #Neuromotor NDDs Children without

Candidate Test Impairment Alone Impairment + without NMI# NMI and NDDs
(N= 58) Other NDDs (N=208) (normal)#(N=56)
Group-I (N=92) Group-III Group-IV
Group-II

Neuromotor impairment 52 77 17 2
No neuro-motor impairment 6 15 191 54
Sensitivity % (95% CI) 89.7 (78.8-96.1) 83.7 (74.8- 90.6) _ _
Specificity % (95% CI) – – 91.8 (87.3-95.2) 96.4 (87.7-99.6)
+Likelihood Ratio (Group 1 and III) 11 (6.9-17.4) – Likelihood Ratio (Group 1 and III) 0.1 (0.05-0.24)
+Likelihood Ratio (Group 1 and IV) 25.1 (6.4-98.2) – Likelihood Ratio (Group 1 and IV) 0.1 (0.05-0.22)
+Likelihood Ratio (Group I1 and III) 10.2 (6.4-16.3) – Likelihood Ratio (Group I1 and III) 0.1 (0.1-0.28)
+Likelihood Ratio (Group I1 and IV) 23.4 (5.9-91.7) – Likelihood Ratio (Group I1 and IV) 0.1 (0.1-0.26)

Figures in parenthesis are 95% CI; * Out of 454 subjects, 40 (8.8%) were categorized as Indeterminate; 38/40 (95%) had NMI with or without NDD
and were referred for further workup. Details of indeterminate cases are given in the text; # These are the diagnostic categories as per expert
evaluation (Gold Standard).

spasticity (14 patients), ataxia (2 patients) and dystonia and other NMI after initial diagnosis has been made and
(one patient). Over two-third of these (15/21) were to assess the quality of life of patients and their
associated with other NDDs as well. The neuro-motor caregivers [17-20]. Tiered approach involving initial
impairment was mild in most of these children. There community screening followed by diagnostic assignment
were 19 false positives: 17 with different NDDs and 2 by an expert have been applied in epidemiologic studies
from normal category. Eleven of these children had [21-23]. Use of motor developmental milestones to
varying degree of intellectual disability and 2 had autism. screen for delays and identify children with CP has been
Seizure disorder was also present either as isolated evaluated in a group of high-risk, prematurely born
condition (n=3) or with other NDDs (n=5). Two children infants below two years of age [18-20]. Kuban, et al. [24]
without any NDD had rickets (n=1) and moderate under- incorporated selected components from standard
nutrition (n=1). INDT-NMI categorized the false neurological examination to an algorithm for identifying
positives as having CP in 17 cases and one each with cerebral palsy in 2-year-old children who were born at
NMD and other NMI. extremely low gestational age, in a multi-centric
epidemiological study. The minimum threshold criteria
DISCUSSION
for identifying cerebral palsy were specified but the
The diagnosis of neuro-motor impairments including diagnosis of CP using this algorithm was not validated
cerebral palsy is essentially clinical. In this study on using any reference standard assessment. Similar to our
development and validation of a simple clinical tool study, efforts to strengthen primary care have been made
(INDT-NMI), good psychometric properties (sensitivity in China with recent validation of Chinese version of
75.4% and specificity 86.6%) were observed. About 9% INFANIB for assessing infants with neuromotor
subjects were categorized as ‘indeterminate’ and most of abnormalities in primary care setting [25].
these (95%) were having either NMI or had another
In the current study, over 86% of true positives were
NDD.
correctly classified in to the various sub-types of NMI.
The concept and definition of CP has changed over Clinically, it is important to differentiate CP from other
years reflecting the evolving understanding of causative neuromotor impairment and neuromuscular disorders for
mechanisms and varied manifestations [11,13-16]. To the deciding the line of investigations, specific therapeutic
best of our knowledge, no validated tools for diagnosing and rehabilitative interventions, and counseling. In our
and categorizing neuro-motor impairments for children patients, 70% children with NMI had other co-
older than two years are available. Several assessment morbidities like epilepsy, global developmental delay
tools are however, available to quantify and monitor and intellectual disabilities. Similar findings have been
developmental milestones and skills in children with CP described in other studies and therefore there is need for a

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WHAT IS ALREADY KNOWN?

• The diagnosis of neuromotor impairments is essentially clinical.
• Primary care physicians have limited knowledge and skills to diagnose these conditions.
WHAT THIS STUDY ADDS?
• INDT-NMI is a simple diagnostic tool based on algorithmic approach developed by a large group of experts using
modified Delphi technique.
• INDT-NMI demonstrated good sensitivity (75%) and specificity (87%) to diagnose neuromotor impairments in
children.

comprehensive assessment of all these subjects. In any Funding: Ministry of Social Justice and Empowerment
situation, once diagnosis of NMI is made in primary care, (National Trust), National Institute of Health (NIH-USA);
physiotherapy can be initiated early while detailed Fogarty International Center (FIH), Autism Speaks (USA);
specialist assessment is underway. Triage questions of the Competing interests: None stated.
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