Journal of Pharmaceutical Research International

33(59B): 88-95, 2021; Article no.JPRI.76223

ISSN: 2456-9119
(Past name: British Journal of Pharmaceutical Research, Past ISSN: 2231-2919,
NLM ID: 101631759)

Effectiveness of Pelvic Proprioceptive

Neuromuscular Facilitation Techniques on Balance
and Gait Parameters in Children with Spastic
Diplegia: A Study Protocol for a Randomized Clinical
Trial
Vikrant Salphale a≡, Rakesh Krishna Kovela a*ⱷ,
Mohammad Irshad Qureshi a# and Pallavi Harjpal a≡
a
Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College Datta Meghe Institute of
Medical Sciences, Sawangi, Meghe, Wardha, Maharashtra, India.

Authors’ contributions

This work was carried out in collaboration among all authors. All authors read and approved the final
manuscript.

Article Information
DOI: 10.9734/JPRI/2021/v33i59B34356

Open Peer Review History:

This journal follows the Advanced Open Peer Review policy. Identity of the Reviewers, Editor(s) and additional Reviewers,
peer review comments, different versions of the manuscript, comments of the editors, etc are available here:
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Received 10 October 2021

Study Protocol Accepted 14 December 2021
Published 17 December 2021

ABSTRACT
Background: Cerebral Palsy is a spacious term which highlights an extensive gamut of motor
affliction which has a stagnant tendency. The estimated Cerebral Palsy is indeed very prevalent in
developed nations 2 out of the next 1000 live births and neonatal survivors. Among several
Cerebral Palsy comes in a variety of manifestations. Spastic Diplegia is common in a majority of
Preterm babies. Several treatment strategies of Physical therapy are utilized for Spastic Diplegia.
This research focusses on assessing the Efficiency of Pelvic Proprioceptive Neuromuscular
Facilitation (PNF) techniques over the Dimensions of Balance and Gait in children with Spastic
Diplegia.
Objective: To evaluate the Effectiveness and impact of the techniques of Pelvic Proprioceptive
Neuromuscular Facilitation (PNF) on Balance, Gait Parameters and Pelvic Asymmetry in children
having Spastic Diplegia.
_____________________________________________________________________________________________________
≡
Resident;
ⱷ
Associate Professor;
#
Professor and Head;
*Corresponding author: E-mail: rakeshkrishna.pt@gmail.com;
 Salphale et al.; JPRI, 33(59B): 88-95, 2021; Article no.JPRI.76223

Methods: In this Randomized Clinical Trial, subjects (n= 40) having Spastic Diplegia will be
selected and segregated in two groups using simple random sampling method with 1:1 allocation
ratio. The allocation will be done through sequentially numbered opaque sealed envelope
(SNOSE). Subjects in the experimental group will receive Pelvic PNF techniques like Rhythmic
initiation and Slow reversal with Task- Oriented training which will contain sit to stand exercises,
walking on the ground and reaching tasks for improving the balance and those in the other group
will be given only Task- Oriented training for 4 weeks following baseline assessments. Throughout
the treatment session and following 4 weeks follow up will be taken by assessing the Balance and
Gait parameters of the subjects. The study duration will. be of 1 year. Subjects with Spastic
Diplegia with an age group of 8 to 12 years who are able to do independent sitting, who are
coming under GMFCS level I to III and those who are having pelvic asymmetry will be included in
the study while subjects who had any surgery of spine or lower limb in past 6 months, who are
having fixed deformities of spine or lower limb or any fracture or dislocation of spine or lower limb
will be excluded from the study.
Results: Results will be recorded by using the outcome measures and instruments such as
Pediatric Balance Scale, Gait Parameters and Palpation meter device at the end of the intervention
and the effects of Pelvic PNF techniques will be compared with the other group which will receive
Task oriented training. The statistical analysis will be done by using paired t test but if the data
does not follow a normal distribution then Wilcoxon sign rank test will be used.
Discussion: The intention and motive of the study is to check the Effectiveness of Pelvic
Proprioceptive Neuromuscular Facilitation techniques on Balance and Gait Parameters in children
with Spastic Diplegia.
Conclusion: The conclusion of this research is to acquire the fruitfulness of Approaches of Pelvic
PNF on Balance and Gait Parameters in children having Spastic Diplegia.

Keywords: Pelvic proprioceptive neuromuscular facilitation; task oriented training; spastic diplegia;
pelvic asymmetry.

CTRI Number: CTRI/2021/05/033727

1. INTRODUCTION dysfunction. Topographically it is categorized as

Monoplegia, Diplegic, Triplegic, Quadriplegic,
The term Cerebral Palsy represents a diverse Hemiplegic and Paraplegic. On the other hand,
array continuum of motor dysfunction with a according to motor deficits it is categorized as
non-progressive nature. Cerebral palsy signifies Spastic, Athetoid, Ataxic, Flaccid and Mixed.
a division of a continuous motion malleable and Cerebral palsy can occur either before, during or
demeanour- generating functional restriction immediately after the birth of the child therefore
disorders that are due to stagnant diseases that the reason why cerebral palsy can be either
have emerged in the evolving foetal or child antenatal, neonatal or postnatal.
brain.
According to the abilities of children to execute
Motor defects and dysfunctions of the cerebral the Gross Motor activities they are
palsy are also accompanied by visual categorized in according to five distinct levels to
abnormalities, memory, seizures and secondary the Gross motor function classification system
musculoskeletal complications [1]. [3].
Pervasiveness of cerebral palsy in developed Spasticity is categorised as an exaggerated
nations is 2 per 1000 live births and neonatal resilience to passive muscle or motion which is
survivors. According to the population-based dependent on the velocity of movement or an
research of cerebral palsy males are found to inappropriate voluntary muscle task associated
have a greater Pervasiveness of cerebral palsy with an upper motor neuron paralysis [4].
compared to females, with sex ratios ranging
from 1:1:1 to 1.5:1.[2]. Spastic Diplegia is a common variant of
Cerebral Palsy in preterm children, particularly in
Cerebral palsy is classified in different types the most unripped preterm children. Majority of
according to the topography and motor children having Spastic Diplegia presents with a

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healthy tone or even hypotonia, during the 1.1 Need for the Study
period of initial four months. During the first year
spasticity have a subtle commencement and a Pelvis is a part of the trunk that helps in
sluggish progression in the legs [5]. facilitating the motion of extremities or limbs.
Pelvic asymmetry is common in children having
Usual problems resulting from Cerebral Palsy Cerebral Palsy. Asymmetry in the pelvis
include the contractures of muscles and interferes with the effective movement of
connective tissues, cognitive and perceptual extremities or limbs. Both the Task-oriented and
problems, visual and visuomotor problems, the PNF have been mentioned to be helpful for
speech and learning impairments, lack of trunk the improvement of lower extremity functions.
control, asymmetry of the pelvis, abnormalities Studies have shown that pelvic PNF has a
in gait and balance etc [6,7]. positive contribution on trunk function [15]. There
is a deficiency of literature which emphasizes the
There are several techniques and interventions role of the pelvic PNF in lower extremity function,
which are used for the purpose of treatment in Balance and Gait Parameters.
Spastic Diplegia for example Strength training
programs, Task oriented training, Sensorimotor 1.2 Hypothesis
training program, Balance training,
Neurodevelopmental therapy and Proprioceptive 1.2.1 Alternative hypothesis
Neuromuscular Facilitation to improve the Gait
and Balancing abilities [8-11]. Pelvic PNF will impose a positive impact on
Balance, Gait Parameters and Pelvic Asymmetry
PNF is a strategy of therapeutic exercise in in children with Spastic Diplegia.
which the functionally based diagonal patterns of
motion are blended with the strategies of 1.2.2 Null hypothesis
Neuromuscular abetment to endorse the motor
feedback and enhance the Neuromuscular Pelvic PNF will have no significant effect on
control and function [12]. The approach of PNF Balance, Gait Parameters and Pelvic Asymmetry
was discovered during the time period of 1940s in children with Spastic Diplegia.
and 1950s by Kabat, Knott and Voss [13]. PNF
practises are often preceded by verbal/ visual 2. METHODOLOGY
and tactile input to promote and achieve muscle
contraction and motor control. PNF stretches are 2.1 Study Setting
highly effective in improving the strength,
flexibility and range of motion but they are The research will be executed in the Outpatient
complex and involve several movements for an wing of AVBR Hospital,Sawangi, Meghe,
individual stretch. Wardha.
Task- oriented instruction signifies to the
2.2 Study Design and Sample Size
practice of executing important functional
activities or works so that a well-organized and
In this Randomized Clinical Trial. The number of
effective motor skulls can be learned. Task
subjects enrolled in the experimental study will
oriented training is based on systems archetype
be 40 (n=40).
of motor control and existing postulates of motor
erudition.
2.3 Study Population
This approach emphasizes on interactions
between power components in the sensorimotor Subjects having Spastic Diplegia
system, stamina, range of motion, coordination,
sensory perception and postural awareness. It 2.4 Sample Size Calculation
uses the principles of degrees of control and
perceptual ability, as well as the philosophy of For calculation of sample size paired t test will be
autonomous movement and legislation [14]. used with 20 subjects in each group.
: To calculate the sample size, the technique of
The study's goal is to draw the Potency of Pelvic estimation of sample size for paired t test will be
PNF Techniques on Balance and Gait used.
parameters in children with Spastic Diplegia.

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n = [(Z1-α /2+ Z1-β)²]/ σ ² + (Z1-α/2)²/2 2.11 Sample Size Consideration

Where α is the level of significance (5%),1-β This Randomized Clinical Trial is an

is the power (80%) and σ is the effective experimental two group design which is
size (0.5), lost to follow up (20%) evaluating the Effectiveness of Pelvic PNF
n=(1.96+0.84)²/0.5² + (1.96)²/2 n=33 Techniques on Balance and Gait parameters in
children with Spastic Diplegia. Total 40 subjects
Sample size is 40 with 20% lost to follow up. will be taken and then after they will be
randomized.
2.5 Sample Size
2.12 Intervention Design
40.
40 subjects with Spastic Diplegia and Pelvic
2.6 Inclusion Criteria asymmetry will be selected from the
Physiotherapy OPD of AVBR Hospital and
Subjects within the age groups of 8 to 12 (as segregated in two different groups
they can understand the commands of the
therapist) years of either gender having Spastic Group A- Intervention group
Diplegia with Pelvic asymmetry, GMFCS level I Group B- Comparator group
to III and MMSE score equal to 22 or more than
22 and children who are able to sit Group A: Group A will receive Pelvic
independently. Proprioceptive Neuromuscular Facilitation (Pelvic
PNF) as well as the Task Oriented Exercises for
2.7 Exculsion Criteria Lower extremities. The Pre- treatment
assessment of the subjects will be recorded by
Children under botoux medication for a period of using the Pediatric Balance Scale (ICC>0.9),
more than six weeks, who had any surgery of Gait Parameters and Palpation meter device
spine or lower limb in the preceding six months (ICC= 0.90).
and those who were having any fractures of
spine or lower limb in the preceding six months. Pelvic Proprioceptive Neuromuscular Facilitation
techniques will include Rhythmic Initiation
2.8 Participant Timeline technique and Slow reversal technique and the
Task- Oriented Exercises will include Sit to Stand
The duration of study is 1 year and that of Exercises, Walking on the ground and Reaching
intervention is 4 weeks so participants will be tasks for improving Balance.
enrolled during first 11 months of study so 4-
week intervention will be completed successfully. Rhythmic Initiation- In this technique initially the
st
Assessment will be taken on 1 day by using therapist will move the patient through a desired
PBS, PALM and Gait Parameters. movement by using the Passive range of
motion, latter an active- assisted, active- resisted
2.9 Implementation range of motion, and at the end active range of
motion.
Research coordinator and Principal investigator
will supervise the process of randomization. Slow Reversal- It utilizes an isotonic contraction
Participants will be asked to manually select the of the agonist group instantly followed by an
envelope, sealed group allocation for the isometric contraction, with a hold instruction
recruitment into either group. which is given at the end of every active
movement.
2.10 Blinding
The time span of Pelvic Proprioceptive
While assigning the subjects to the group the Neuromuscular Facilitation will be 15 minutes for
assessor will be blinded. To ensure blinding both the sides including Task- oriented tutoring
subjects will be mandated not to reveal any for a period of 30 minutes, 6 days per week for 4
details of their treatment to the assessor. weeks.

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40 Subjects will be chosen on the

basis of the inclusion criteria

Randomization

Group A- Pelvic PNF with Group B- Task

Task oriented training oriented training

4 weeks of Intervention 4 weeks of Intervention

Pelvic PNF- 15 minutes for both
the sides Task oriented training- 30
Task oriented training- 30 minutes 6 days in a week
minutes 6 days in a week

Post Treatment assessment of the

subjects will be done after 4 weeks by
using PALM, PBS and Gait Parameters

Statistical Analysis

Fig. 1. Schematic diagram of sample analysis

Post assessment of the subjects will be recorded Group B: Group B will receive only Task
by using the same outcome measures (PBS, Oriented Exercises for lower extremities which
Gait Parameters and PALM) at the end of the will include sit to stand exercises, walking on the
treatment or after the intervention. ground and reaching tasks for improving
balance.

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The baseline assessment of the subjects will be 3.6 Data Collection and Management
done by using Pediatric Balance Scale (PBS),
Gait Parameters (Cadence, Stride length and The data of the subjects will be collected prior to
Gait velocity) and Palpation meter device (PALM) the treatment (Pre-treatment) and after the
which will measure the asymmetry in the intervention or treatment by using Pediatric
pelvis.The time duration of treatment for group B Balance Scale, Gait Parameters and Palpation
will be of 30 minutes, 6 days per week for 4 Meter device.
weeks.
3.7 Statistical Analysis
Post assessment of the subjects will be done by
using PBS, Gait parameters and PALM which To find out the impact of Pelvic PNF techniques
are mentioned above in the baseline or Pre on trunk control in children with Spastic Diplegia
assessment of the subjects after the intervention. paired t test will be used but if the data does not
follow a normal distribution then Wilcoxon sign
3. OUTCOME MEASURES rank test will be used.

3.1 Pediatric Balance Scale (PBS) 4. DISCUSSION

It is a transformation of the Berg Balance Scale The purpose of this Randomized Clinical Trial
which is used for the purpose to estimate the Research study is to evaluate the Potency of
functional balancing abilities in school aged Pelvic PNF Techniques on Balance and Gait
children. The optimum score of Pediatric Balance Parameters in children having Spastic Diplegia.
Scale is 56 [16]. This study will also provide a literature
concerning the impact of Pelvic PNF on Pelvic
3.2 Gait Parameters asymmetry in Spastic Diplegic Cerebral Palsy
children. Some researches have proved that
Gait Parameters will be including the following Pelvic Proprioceptive Neuromuscular Facilitation
techniques have a good and positive impact on
Cadence improving the functions of trunk in Cerebral Palsy
Stride length as well as in improving the functions of lower
Gait Velocity extremities.

3.3 Mini Mental Status Examination 5. CONCLUSION

(MMSE)
The conclusion of this research is to acquire the
Mini Mental Status Examination Scale is mainly fruitfulness of Approaches of Pelvic PNF on
used to check the impairment in the cognitive Balance and Gait Parameters in children having
functions of individuals. It has a maximum score Spastic Diplegia.
of 30 and the acerbity in the cognitive impairment
will depend upon the score of Scale. CONFIDENTIALITY

3.4 Gross Motor Function Classification The study program will be explained to the
System (GMFCS) participant, the Principal Investigator will record
the subjective information. The consent form will
On the basis of Gross Motor Function include the confidentiality statement and
Classification System (GMFCS) children are signatures of the principal investigator, patient
classified in five different standards according to and witnesses. If required to disclose some
their potential to execute the Gross Motor actions information for the study, consent will be taken
[17]. from the patient with complete assurance of his
confidentiality.
3.5 Palpation Meter Device (PALM)
FUNDING
Palpation meter device is an instrument which is Funding will be provided by the Research Cell of
used to measure and check the extent of Datta Meghe Institute of Medical Sciences,
asymmetry in the pelvic region [18]. Wardha, Maharashtra, India.

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FUTURE SCOPE OF THE STUDY 5. Fenichels Clinical Pediatric Neurology A

Signs And Symptoms Approach PDF Book
Pelvic PNF can be an effective technique in - Online Library [Internet]. [cited 2021 Mar
Spastic Diplegia to improve the Balance and Gait 6].
Parameters by emphasizing on and improving Available:https://glarqual.caringchoices.org
the pelvic control. .uk/file-ready/fenichels-clinical-pediatric-
neurology-a-signs-and-symptoms-
IMPLICATION OF THE STUDY approach
6. ElBasatiny H, Abdelaziem A. Effect of
If the study is proved to be effective then training Trunk Exercises on Trunk control, Balance
and enhancing the pelvic control will be an active and Mobility Function in Children with
ingredient in treatment of children with Spastic Hemiparetic Cerebral Palsy. Int J Ther
Diplegia. Rehabil Res. 2015;4(5):236.
7. Physiotherapy in Pediatrics : Roberta B.
CONSENT Shepherd : 9780750606202 [Internet].
[cited 2021 Mar 6].
Principal Investigator will obtain the written Available:https://www.bookdepository.com/
informed consent and accent forms from the Physiotherapy-Pediatrics-Roberta-B-
participants on a printed form (local language) Shepherd/9780750606202
with signatures and give the proof of 8. Agrawal A. The concept of neurosciences
confidentiality. The participant individuals in rural practice. J Neurosci Rural Pract.
of the study and DMIMSU who will fund it will be 2010;1(1):1.
able to retrieve findings of study. After 9. Agrawal A, Joharapurkar SR, Gharde P.
completion of study and publication of results Ischemic stroke in a child mistaken as
data will be stored in the DMIMSU data functional disorder. Clin Neurol Neurosurg.
repository. 2007;109(10):876–9.
10. Agrawal A, Bhake A. Giant testicular tumor
ETHICAL APPROVAL with pulmonary metastases: Stroke as the
initial manifestation. Indian J Cancer.
The study will conducted after receiving the 2015;52(1):59–60.
approval from the Institutional Ethical Committee 11. Cincu R, Agrawal A, Eiras J. Intracranial
of Datta Meghe Institute of Medical Sciences arachnoid cysts: Current concepts and
(Ref.no.DMIMS(DU)/IEC/2021/249). treatment alternatives. Clin Neurol
Neurosurg. 2007;109(10):837–43.
COMPETING INTERESTS 12. Effectiveness of physical therapy
interventions for children with cerebral
Authors have declared that no competing palsy: a systematic review - PubMed
interests exist. [Internet]. [cited 2021 Mar 6].
Available:https://pubmed.ncbi.nlm.nih.gov/
REFERENCES 18435840/
13. Joint Structure and Function: A
1. A report: the definition and classification of Comprehensive Analysis | Levangie PT
cerebral palsy April 2006. Dev Med Child DPT DSc FAPTA, Pamela K., Norkin PT
Neurol. 2007;49(s109):8-14. EdD, Cynthia C. | download [Internet].
2. Pakula AT, Van Naarden Braun K, [cited 2021 Mar 6].
Yeargin-Allsopp M. Cerebral palsy: Available:https://b-
classification and epidemiology. Phys Med ok.asia/book/5264529/c5647f
Rehabil Clin N Am. 2009 ;20(3):425–52. 14. Kumar C, Ostwal P. Comparison between
3. Pediatric Physical Therapy |c Jan Stephen Task - Oriented Training and
Tecklin | download [Internet]. [cited 2021 Proprioceptive Neuromuscular Facilitation
Mar 6]. Available:https://b- Exercises on Lower Extremity Function in
ok.asia/book/2492419/f2e82c Cerebral Palsy-A Randomized Clinical
4. Management of spasticity in children with Trial; 2016.
cerebral palsy. [Internet]. [cited 2021 Mar 15. Shanmugam AN, S, P SR. Effectiveness of
6]. Pelvic Proprioceptive Neuromuscular
Available:https://www.cabdirect.org/cabdire Facilitation on Trunk Control in Children
ct/abstract/20143315161 with Spastic Diplegia:A Randomized

94
 Salphale et al.; JPRI, 33(59B): 88-95, 2021; Article no.JPRI.76223

Controlled Trial. Indian J Public Health Res classification system and manual ability
Dev. 2020;11(2):571-576–576. classification system in children with
16. Sook- Hee Yi, Ji Hye Hwang Validity of cerebral palsy in Tanzania. Developmental
pediatric balance scale in children with Neurorehabilitation; 2017.
spastic cerebral palsy. Neuropaediatrics; 18. Matthew R Patrone, Jennifer Guinn The
2012. Accuracy of the Palpation Meter for
17. Daniele Piscitelli, Stefano Vercelli measuring pelvic crest height difference
Reliability of the gross motor function and leg length discrepancy. JOSPT; 2003.

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