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CTRI Number  CTRI/2024/08/072064 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between the Effectiveness of Sensory Integration Therapy and Traditional Physical Therapy on Gross Motor Abilities in the Children with Spasmodic Paralysis of Corresponding Parts on both sides of the Body 
Scientific Title of Study   Efficacy of Sensory Integration Therapy Versus Conventional Therapy on Gross Motor Function in Spastic Diplegic Cerebral Palsy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pritilekha Das  
Designation  Master of Physiotherapy Student 
Affiliation  Burdwan Institute of Medical and Life Sciences 
Address  Burdwan Institute of Medical and Life Sciences University Campus, Golapbag, University Road, Bardhaman, West Bengal, Country-India, Department of Physiotherapy, Ground Floor, Exercise Lab.
Barddhaman
Barddhaman
WEST BENGAL
713104
India 
Phone  9836714287  
Fax    
Email  priteelekha2021@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Priyanka Das 
Designation  Assistant Professor 
Affiliation  Burdwan Institute of Medical and Life Sciences 
Address  Burdwan Institute of Medical and Life Sciences University Campus, Golapbag, University Road, Bardhaman, West Bengal, Country- India, Department of Physiotherapy, Ground Floor, Exercise Lab.
Barddhaman
Barddhaman
WEST BENGAL
713104
India 
Phone  8617055472  
Fax    
Email  dr.priyadas03@gmail.com  
 
Details of Contact Person
Public Query  
Name  MS Anwar 
Designation  Principal 
Affiliation  Burdwan Institute of Medical and Life Sciences 
Address  Burdwan Institute of Medical and Life Sciences University Campus, Golapbag, University Road, Bardhaman, West Bengal, Country- India, Department of Physiotherapy, Ground Floor, Exercise Lab.
Barddhaman
Barddhaman
WEST BENGAL
713104
India 
Phone  9732445289  
Fax    
Email  bimls.principal@gmail.com  
 
Source of Monetary or Material Support  
Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road, Bardhaman, West Bengal 713104, Country- India, Department of Physiotherapy, Ground Floor, Exercise Lab. 
 
Primary Sponsor  
Name  Priyanka Das 
Address  Burdwan Institute of Medical and Life Sciences University Campus Golapbag, Burdwan - 713104, West Bengal, Country- India, Department of Physiotherapy, Ground Floor, Exercise Lab. Burdwan West Bengal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
PRITILEKHA DAS  Burdwan Institute of Medical and Life Sciences  Burdwan Institute of Medical and Life Sciences University Campus, Golapbag, University Road, Bardhaman, West Bengal-713104, Country- India, Department of Physiotherapy, Ground Floor, Exercise Lab.
Barddhaman
WEST BENGAL 		 9836714287

priteelekha2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Burdwan Institute of Medical and Life Sciences Barddhaman India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Therapy  Conventional Therapy: For the upper limb, lower limb, and trunk, stretching exercises, strengthening exercises and range of motion exercises were given. Transition activities in supine lying, crawling, rolling, sitting, kneeling, standing, and walking. Exercise type : Core stability exercise (Isometric abdominals, isometric trunk extension, bridging, modified bridging, curl up), Active exercise within available range (specific muscle activity), self-initiated perturbations (reach outs in anterior, medial, lateral direction with various range of distances), facilitation of balance reactions (in sitting and standing with balance board, bolster), facilitating postural stability during transitions (in transition with help of tactile cues and feedback). Conventional therapy includes icing, passive stretching and sponge ball exercise to the hand also. The training includes Stretching-calf muscle (hamstring), Swiss ball exercises (hamstring curl, trunk control exercise), Weight bearing exercise (positioning exercise, kneeling exercise, half kneeling, squatting), Balance training – parallel bar training (single leg balance, sit to stand , heel raise forward, lateral step up), gait training (heel to toe walk, lifting your legs, sitting down, standing up, stepping over objects). Duration: Each Session will be of 45-60 minutes treatment duration, 4-5 days per week for a period of 2 months. 
Intervention  Sensory Integration Therapy  Sensory Integration Therapy (SIT): Sensory Integration Therapy is a clinical-based technique that emphasizes the therapist-child interaction and employs play-based sensory and motor exercises to promote sensation processing and integration. SIT appears to have significant potential as a treatment. The current goal of sensory integration therapy (SIT) is to reduce or eliminate problems of neuronal disorganization. Neuronal disorganization refers to a problem in responding appropriately to the stimuli reaching the body. Sensory systems include proprioception from muscles and joints, balance and hearing from the vestibuloauditory system, visual stimuli provided by vision, tactile sensory stimuli from the skin, and body awareness. SIT is an active therapy, and the activities usually involve the use of large pieces of equipment such as big rolls and balls, trampolines, swinging hammocks, which provide intense proprioceptive, vestibular and tactile experiences. Duration: Each Session will be of 45-60 minutes treatment duration, 4-5 days per week for a period of 2 months. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Spastic Diplegic Cerebral Palsy, which confirmed by a pediatrician, neurologist, pediatric neurologist.

2.Children with GMFCS Level I, II, III.  
 
ExclusionCriteria 
Details  1. Had no additional disease.

2. Had not undergone surgery in the last 6 months.

3. Children with mental retardation.

4. Muscle contracture.

5. Bony deformity.

6. Communication problems.

7. Children diagnosed with Hyperactivity and Attention Deficit Disorder.

8. Children with learning difficulty.

9. Children having uncontrolled seizures for the past six months. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Gross Motor Function Measurement-88  Each Session will be of 45-60 minutes treatment duration, 4-5 days per week for a period of 2 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Short Sensory Profile  Each Session will be of 45-60 minutes treatment duration, 4-5 days per week for a period of 2 months. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 

  INTRODUCTION

Cerebral palsy 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”. The incidence of CP is 2-2.5/1000 live births. Spastic CP accounts for more than 70% of all CP. 75-80% 0f the cases are due to prenatal injury, less than 10% being due to significant birth trauma or asphyxia.

The cause of CEREBRAL PALSY can be Pre-natal, Peri-natal, Post-natal.

• Prenatal /Antenatal Causes are ‘TORCH’ infections [Toxoplasmosis, rubella, cytomegalovirus, herpes simplex virus), Smoking/ alcoholism, Diabetes/hypertension, Fall, Consanguineous marriages, Rh incompatibility, Drug addicted mother, Hypoglycaemia, Malnourishment of the foetus, Exposure of the mother’s abdominal area to repeated X-Ray radiation, Prolonged use of medications like steroids by mother.

• Perinatal/ Neonatal Causes are Forceps delivery, Breech presentation, Premature delivery, Entangling of placenta around the neck, Vascular causes (occlusion of the internal carotid or mid-cerebral artery), Trauma, Asphyxia, Neonatal meningitis.

• Postnatal causes are Jaundice, Fall from height, Neonatal infection (example: meningitis), Delayed cry, Infection.

CP is classified according to Tone:

a. Spastic

b. Athetoid

c. Ataxic

d. Mixed

e. Flaccid

Spastic Cerebral Palsy:

This is the most common type of cerebral palsy. It is characterized by increased tone in the muscle. Increased tone results in contractures and deformities. The movements in these kids are slow and awkward. These kids usually suffer from mental retardation and cognitive problems, difficulty in motor learning and delayed mile stones.

There are various management regarding Cerebral Palsy like i.e. surgical management and conservative management. In Conservative Management there are Medical management, physiotherapeutic rehabilitation, occupational therapy, speech therapy, prosthetic and orthotic management, and family counselling etc.

a. Physiotherapeutic Rehabilitation: Physiotherapeutic management includes so many techniques like Balance Training, Postural Control, Sensory Integration Therapy, Neurodevelopmental Technique, Conventional Therapy, Progressive Movement Pattern, Synergistic Movement Patterns, Proprioceptive Neuromuscular Facilitation.

But here I have taken Sensory Integration Therapy and Conventional Therapy for improving Gross Motor Function for Spastic Cerebral Palsy as these are commonest technique.

DIFFERENT APPROACHES USED IN CP:

Conventional Therapy: For the upper limb, lower limb, and trunk, stretching exercises, strengthening exercises and range of motion exercises were given. Transition activities in supine lying, crawling, rolling, sitting, kneeling, standing, and walking. Exercise type : Core stability exercise (Isometric abdominals, isometric trunk extension, bridging, modified bridging, curl up), Active exercise within available range (specific muscle activity), self-initiated perturbations (reach outs in anterior, medial, lateral direction with various range of distances), facilitation of balance reactions (in sitting and standing with balance board, bolster), facilitating postural stability during transitions (in transition with help of tactile cues and feedback). Conventional therapy includes icing, passive stretching and sponge ball exercise to the hand also. The training includes Stretching-calf muscle (hamstring), Swiss ball exercises (hamstring curl, trunk control exercise), Weight bearing exercise (positioning exercise, kneeling exercise, half kneeling, squatting), Balance training – parallel bar training (single leg balance, sit to stand , heel raise forward, lateral step up), gait training (heel to toe walk, lifting your legs, sitting down, standing up, stepping over objects).

Sensory Integration Therapy (SIT): Sensory Integration Therapy is a clinical-based technique that emphasizes the therapist-child interaction and employs play-based sensory and motor exercises to promote sensation processing and integration. SIT appears to have significant potential as a treatment. The current goal of sensory integration therapy (SIT) is to reduce or eliminate problems of neuronal disorganization. Neuronal disorganization refers to a problem in responding appropriately to the stimuli reaching the body. Sensory systems include proprioception from muscles and joints, balance and hearing from the vestibuloauditory system, visual stimuli provided by vision, tactile sensory stimuli from the skin, and body awareness.

SIT is an active therapy, and the activities usually involve the use of large pieces of equipment such as big rolls and balls, trampolines, swinging hammocks, which provide intense proprioceptive, vestibular and tactile experiences.

Sensory integration therapy: Visual perception activities: Block design, finding shapes in pictures, puzzles, matching geometric shapes and letters, numbers, and classification; Body awareness: Pointing to the body parts, life-size drawing turning left and right side and awareness of the body parts through touch; Tactile perception: textures, touching boards and feeling shapes; Visual-motor coordination training: Ocular – pursuit training, moving ball and pegboard activities.

Proposed topic of research:

EFFICACY OF SENSORY INTEGRATION THERAPY VERSUS CONVENTIONAL THERAPY ON GROSS MOTOR FUNCTION IN SPASTIC DIPLEGIC CEREBRAL PALSY

Objective of proposed research: To Compare effectiveness of Sensory Integration Therapy and Conventional Therapy for Spastic Diplegic Cerebral Palsy.

Background of present study: CEREBRAL PALSY (CP) is a non-progressive but not necessarily unchanging neurological disorder of children.

Spastic Diplegic Cerebral Palsy is very common type of cerebral palsy and a part of upper motor neurone syndrome. The primary problem in spastic cerebral palsy is developmental delay, hyperreflexia, involuntary movement with impair functional activity.

The primary challenge in Cerebral Palsy is Gross Motor Dysfunctions.

There are lots of research and treatment available on functional outcome of cerebral palsy, including them NDT, ROODS APPROACH, SENSORY INTEGRATION THERAPY, CONVENTIONAL THERAPY shows wonderful effect for developing functional outcome.

There are very less study available to find out the effect of Sensory Integration Therapy and Conventional therapy to improve functional activity in patient with spastic cerebral palsy.

So that in this study I will make an effort to find out the effectiveness of Sensory Integration Therapy and Conventional Therapy in improving the ability of Gross Motor Function in children with Spastic Cerebral Palsy.

RESEARCH HYPOTHESIS

NULL HYPOTHESIS (H0):

There will be no significant difference between Conventional Therapy and Sensory Integration Therapy in improving Gross Motor Function in Cerebral Palsy.

ALTERNATIVE HYPOTHESIS (H1):

There will be significant difference between Conventional Therapy and Sensory Integration Therapy in improving Gross Motor Function in Cerebral Palsy children.


 
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