RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

Annexure-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERATION

1 / NAME OF THE
CANDIDATE AND
ADDRESS / SONIA CHIB.
K.L.E.S INSTITUTE OF PHYSIOTHERAPY,
JAWAHARLAL NEHRU MEDICAL COLLEGE
CAMPUS, BELGAUM- 590 010 KARNATAKA.
2 / NAME OF THE
INSTITUTION / K.L.E.S INSTITUE OF PHYSIOTHERAPY,
JAWAHARLAL NEHRU MEDICAL COLLEGE
CAMPUS, BELGAUM-590 010 KARNATAKA.
3 / COURSE OF STUDY
AND SUBJECT / M.P.T
(PEDIATRIC PHYSIOTHERAPY)
4 / DATE OF
ADMISSION TO
THE COURSE / JUNE 2007
5 / TITLE OF THE
TOPIC / “EFFECTIVENESS OF CUSTOMIZED ELASTIC
STRAP ORTHOTIC GARMENT ON FUNCTIONAL
SKILLS IN SPASTIC DIPLEGICS- A RCT”
6 / BRIEF RESUME OF THE INTENDED WORK :
6.1 Need for the study :
Cerebral palsy (CP) describes “a group of disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behavior, and/or by a seizure disorder.”1
CP is primarily a disorder of movement and posture. It is defined as an “umbrella term covering a group of non progressive, but often changing, motor impairment syndromes secondary to lesions or anomalies of the brain arising in the early stages of its development.”2 It may be stated as a static encephalopathy in which, even though the primary lesion, anomaly or injury is static, the clinical pattern of presentation may change with time due to growth and developmental plasticity and maturation of the central nervous system.
Cerebral palsy is the second- most expensive developmental disability to manage over the course of a person’s lifetime, second to mental retardation.3
Prevalence of CP in industrialized countries of the world ranges from 2 to 2.5 per thousand live births. In infants above 2500gm birth weight, incidence is 1.3 per 1000 live births, 1501 to 2500gm birth weight is 8.5 per thousand live births and below 1500 gm birth weight is 77 per 1000 live births. CP is seen in 10% to 18% of babies having 500 to 900gm birth weight.4 The male female ratio is 1.3:1, with males having a more severe disability.5 In a study conducted in India, it was found that clinical profile of CP including spastic diplegia, was 54%6.
The etiology of CP is very diverse and multifactorial.2 The lesion may be in a single or multiple locations of the brain, resulting in definite motor and possibly sensory abnormality. It occurs as a result of in utero factors, events at the time of labor and delivery (congenital cerebral palsy), or a variety of factors in the early developing years (acquired cerebral palsy).
Etiologic factors underlying CP are usually grouped into pre-, peri-, and postnatal categories. Prenatal factors are hereditary or genetic conditions , prenatal infections including viral (rubella, herpes), bacterial, and parasitic (toxoplasmosis); fetal anoxia caused by hemorrhage from premature separation of the placenta or maldevelopment of the placenta , Rh incompatibility including erythroblastosis fetalis, hemolytic anemia and hyperbilirubinemia, metabolic disorders such as maternal diabetes and toxemia of pregnancy and developmental deficits, which include maldevelopment of the brain, vascular and skeletal structures.7
Perinatal factors include rupture of brain blood vessels or compression of the brain during prolonged or difficult labor and asphyxia caused by drug sedation, distress of labor, premature separation of the placenta and placenta previa or related to prematurity.7
Postnatal factors leading to CP include vascular accidents and intracranial hemorrhage, head trauma, brain infections, including bacterial or viral encephalopathies, toxic conditions such as lead poisoning, anoxia from drowning or cardiac arrest, seizures and tumors.7
Most children with CP are noted to have multiple etiologies, with intra and periventricular bleeds or difficulty maintaining adequate oxygenation because of prematurity being the most common associated factors. Certain etiologic factors predispose to specific clinical types of CP. For example, O’ Reilly and Walentyno- wicz showed in their study of 2,004 children with prematurity or multiple births accounted for 55% of children with spastic diplegia while anoxia, respiratory distress, and erythroblastosis fetalis accounted for 63% of the athetoid children.7
CP can classified under following categories:
1.  Based on neuroanatomy: pyramidal tract or cerebral cortex, extra pyramidal tract (basal ganglia or cerebellum).8
2.  Based on neuromuscular deficits or movement disorders: spastic, dyskinetic which includes choreoathetoid and dystonic, ataxic, hypotonic or mixed with
spastic CP being the commonest.9
3.  Topographic classification is: monoplegia (one limb affected), diplegia involvement of four limbs with lower limbs more affected than upper limbs), triplegia (involvement of three limbs), quadriplegia (involvement of four limbs) and hemiplegia (involvement of one side of body) with diplegia being the commonest.4
4.  Functional impairment which includes mild, moderate and severe.4
Although the hallmark of CP is motor dysfunction, various other problems frequently coexist, including sensory impairment, abnormal muscle tone, posture (i.e. slouching over while sitting), reflexes or motor development and coordination. There can be joint and bone deformities and contractures. Most children with spastic diplegia present with developmental delay mainly gross motor function, mild incoordination problem in upper limb, spasticity, mainly of hip adductors, flexors and gastronemius eventually developing contractures which may lead to deformity. They have crouch gait and walk on toes with flexed knees. Secondary conditions can include seizures, speech or communicative disorders, eating problems, sensory impairment, nystagmus, strabismus, mental retardation, learning disabilities and/or behavioral disorders.
Medical management for the children with spastic diplegia includes oral medications, intramuscular injections of botulinum toxin and injections of phenol into motor nerves, selective dorsal rhizotomy and intrathecal baclofen pump.
Therapies such as physio, speech and occupational therapy are aimed at increasing function and decreasing long term disability.3 Physiotherapy interventions consist of a variety of therapeutic approaches that include Neurodevelopmental therapy (NDT), Vojta’s technique, Roods approach, Proprioceptive Neuromuscular Facilitation (PNF), Sensory Integration, Temple Fay, Myofacial release( MFR), Collis technique, Conductive education, Constraint induced therapy, Electrical stimulation, Hippotherapy, Hyperbaric oxygen, Adeli suit, Massage therapy and hatha yoga.
Along with these approaches, orthotic management also plays a vital role in correcting, supporting or accommodating deformities that in turn enhance patient’s functional abilities or efficiency to aim for activities that require minimum energy expenditure.
Orthotic management that is commonly used in the treatment of spastic diplegic is the usage of Ankle foot orthosis(AFO), which can be static or dynamic, Knee ankle foot orthosis(KAFO), Hip knee ankle foot orthosis(HKAFO) and therapeutic garments made up of latex-free fabrics that are comprised of nylon , the foam backing is a latex-free, aqueous-based elastomeric urethane is also known to benefit the patients by maintaining the postural alignment thereby providing stability and improving movement skills based on the principle of applying prolonged, low load (i.e. gentle), corrective forces to the musculoskeletal system. The muscle groups most often targeted for strapping are underused and overlong. They are the synergists with or the antagonists to the muscles that are dominant in movement. For example, the gluteus medius and minimus muscles are often underused in the presence of a dominant group of hip adductors. So the hip abductors are shortened with customized elastic strap orthotic garment, and then put to work at a more appropriate length in daily function. The basis for the customized elastic strap orthotic garment approach is that it emphasizes shortening the long muscles before lengthening the short muscles, that providing the user with a more effective movement or muscle activation strategy while working to gradually change the existing pathological recruitment strategies.10
Research indicates that children with spastic diplegia can be benefited with this kind of tool that corrects the biomechanical alignment and if given in combination with standard therapy, will produce a better outcome as compared to standard therapy alone.
Due to the scarce literature of this relatively new approach, information available pertaining to its effects on functional parameters is limited. Thereby, this study is intended to determine the effectiveness of customized elastic strap orthotic garment on functional skills in spastic diplegics.
Hypothesis:
Null hypothesis: There will be no improvement on the functional outcome measures (i.e. Gross motor functional measurement scale- 66 (GMFMS-66) and range of motion (ROM) of hip and knee ( by measuring popliteal angle) in children with spastic diplegia treated with combination of customized elastic strap orthotic garment and standard therapy.
Alternative hypothesis: There will be improvement on the functional outcome measures (i.e. Gross motor functional measurement scale- 66 (GMFMS-66) and range of motion of hip and knee (by measuring popliteal angle) in children with spastic diplegia treated with combination of customized elastic strap orthotic garment and standard therapy.
6.2 Review of literature:
A study conducted to asses range of motion of hip and knee, thigh foot angle, gait and functional skills using gross motor function measure (GMFM) showed improvement in spastic diplegics with an elasticized orthotic garment and strapping system.11
Another study intended to asses on gait parameters i.e. base of support, velocity and cadence found similar improvements with Theratogs in children with
spastic hemiplegia.12
Studies done using orthotic undergarment with a strapping system in children with spastic diplegics have reported significant improvement in gait pattern, postural stability, balance and life skills.13
Reliability and validity has been established of the Gross motor function
classification system for CP, developed to classify severity of functional limitations/disability in CP and is considered to be a good clinical tool to predict future function in children with CP.14
A study was done to find the reliability and validity of Gross motor function measure-66(GMFM-66) in children with CP and the test- retest reliability was found to be high and statistically siginificant.15
Study done on goniometry used for the measurement of range of motion (ROM) was found to be valid and reliable method for measuring ROM of the extremities.16
6.3 Objectives of the study:
To asses the functional effectiveness of customized elastic strap orthotic garment in spastic diplegics versus standard therapy
7 / MATERIALS AND METHODS:
7.1 Source of Data:
Pediatric Physiotherapy OPD or referrals from Department of Pediatrics and Child
Development Clinic (CDC), K.L.E.S Prabhakar Kore Hospital and Medical
Research Center, Belgaum-590 010, Karnataka, India.
7.2 Method of Data Collection:
Study design: Randomized controlled trial.
Sample size: 40 participants.(The sample size was calculated by taking an 80% of
the average number of referrals to the pediatric department over period of 3 years).
Sample participants: Male and female children with clinical diagnosis of spastic
diplegia who are referred to the pediatric physiotherapy department and whose
parents are willing to let their children participate in the study.
Sampling method: Convenience sampling method.
Group A: Standard therapy and customized elastic strap orthotic garment- 20cases
Group B: Standard therapy-20 cases.
Materials used :Customized elastic strap orthotic garment, floor mats, measuring
tape, 6 inch step, consent forms, data collection sheet.
Equipments used: Standard Plastic Goniometer.
Inclusion criteria:
1. Both male and female participants with clinical diagnosis of spastic diplegia.
2. Age: 2years to 7 years.
3. GMFCS level 1, 2 and 3.
4. Modified Ashworth scale for spasticity grades 1 and 2.
5. Participants willing to participate in this study.
Exclusion criteria:
1. Children who have been injected with Botox in last 3 months.
2. Any orthopedic surgeries performed within last 6 months.
3. GMFCS level 4 and 5.
4. Children who have associated visual and hearing handicap.
5. Children with fixed contractures/deformities.
6. Children of mental age less than 2 (who can’t follow instructions).
Procedure:
All participants with diagnosis of spastic diplegia that report to Physiotherapy
department will be screened. After finding their suitability as per inclusion and
exclusion criteria, they will be requested to participate in the study. The parent’s
of the participants then will be briefed about the nature of the study and
intervention. A written consent will be obtained from the participants parents. The
participants selected for the study will be randomly allocated into two groups,
namely groupA (Interventional group) and group B (control group) by
convenient sampling using lottery method.
Their demographic data, lower extremity musculoskeletal assessment (LEMA)
which includes range of motion of hip and knee measuring popliteal angle
measured in degrees by goniometer and functional skills by using GMFM- 66 will
be obtained.
In Group A (Standard therapy and customized elastic strap orthotic garment):
Lower extremity musculoskeletal assessment and Gross motor function measure-
66 will be done on each subject at the beginning of the study and one week after
the intervention is completed where as ROM will be measured weekly during the
4 weeks.12The participants will undergo standard therapy program i.e. prolonged
icing for spastic muscle groups, myofacial release, stretching and specific
exercises to improve walking and standing following NDT principles. A rest
interval will be given for 5 to 10 minutes following which the participants will be
gradually introduced to customized elastic strap orthotic garment through a
progressive wearing schedule for 4 weeks. They will be given hipster and vest
that snug fit around the lower pelvis, waist, outer hips, and lower thighs , limb
cuffs will applied to the wearer’s lower leg in standing position. This will promote
hip abduction and lateral thigh rotation. After one week, all of the children will be
given strapping that will assist lateral rotation of the hip. Other straps will be
tailored to the child’s individual weakness and deficits .Parents will be instructed
on the placement of the straps. Each subject will wear the suit with the straps for
one week before receiving any additional strapping. Participants will wear the
customized elastic strap orthotic garment for 6 hours/day,12 6 days per week11 and
will be ambulated a minimum of 30 feet/day.12 The strapping system will be
reevaluated and readjusted each week. After 4 weeks of wearing the customized
elastic orthotic strap the subject will remove suit for 1 full week. The participants
will be returned for a final testing session to determine if there will be any
carryover effects.
In Group B (Standard therapy):The parents of the study participants will be
given prior instructions similar to ‘group A’ as given in a normal clinical