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CTRI Number  CTRI/2024/05/067853 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 08/05/2024
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   Effect of Pilates on balance and sit to stand performance in stroke. 
Scientific Title of Study   Effect of Pilates on balance and sit to stand performance in chronic stroke patients : A Randomized controlled trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kranti Kale 
Designation  Post Graduate Student 
Affiliation  Dr. D Y Patil College Of Physiotherapy,Pimpri,Pune 
Address  Department of Neurosciences, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune. MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9403450979  
Fax    
Email  krantikale59@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti Gazbare 
Designation  Professor 
Affiliation  Dr. D.Y.Patil college of physiotherapy 
Address  Department of Neurosciences, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune. MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9096116134  
Fax    
Email  preeti.gazbare@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Preeti Gazbare 
Designation  Professor 
Affiliation  Dr. D.Y.Patil college of physiotherapy 
Address  Department of Neurosciences, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune. MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9096116134  
Fax    
Email  preeti.gazbare@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr. D.Y.Patil college of physiotherapy, Sant Tukaram Nagar,Pimpri,Pune 
 
Primary Sponsor  
Name  Dr. D. Y. Patil College of Physiotherapy, Pune 
Address  Department of Neurosciences, 3rd floor, Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune. MAHARASHTRA 411018 India 
Type of Sponsor  Other [Private Physiotherapy College] 
 
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 
DrKranti Kale  Dr. D,Y. Patil college of Physiotherapy   Department of Neurosciences, 3rd floor, Dr. D.Y. Patil college of Physiotherapy Sant Tukaram Nagar, Pimpri, Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA 
9403450979

krantikale59@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee of Dr . D.Y. Patil college of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G138||Systemic atrophy primarily affecting central nervous system in other diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coventional Neurophysiotherapy  Functional rehabilitation according to their impairment for stroke and Conventional balance exercise. Given for the four week 3 days/week, 12 sessions  
Intervention  Pilates exercises and conventional Neurophysiotherapy.  The patients will be instructed to perform pilates exercise by using principles of pilates ( Breath , Control, Concentration , Precision , Centre, Flow) along with Functional rehabilitation according to their impairement for stroke and conventional balance exercise. The intervention will be given for 4 week, 3 days/ week( 12 sessions) 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 A diagnosed case of stroke
2 Able to walk independently with or without use of assistance
3 Both gender
4 Berg balance scale (28- 45 medium and low fall risk)
5 Brunnstrom recovery stage 4, 5
6 Trunk impairment scale (10 - 20)
 
 
ExclusionCriteria 
Details  1 Individual suffering from stroke along with other neurological condition like Parkinson’s
2 A Musculoskeletal related deformity like fix – flexed deformity of lower limb
3 Individual having Recent fracture
4 Hemodynamically unstable patient
5 Visual impairment like hemi – neglect

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
NeuroCom Balance Master will be used to assess the following outcomes:

1. Weight transfer
2. Rising index
3. Centre of Gravity- Sway velocity
4. Left and right Weight symmetry .

 
1. At the beginning of intervention
2. At the end of intervention ( after 4 week )

 
 
Secondary Outcome  
Outcome  TimePoints 
miniBEST scale  1. At the beginning of intervention
2. At the end of the intervention ( after 4 weeks )

 
 
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   Phase 2 
Date of First Enrollment (India)   27/05/2024 
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="7"
Days="0" 
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

Stroke , also called as cerebrovascular accident ( CVA) is sudden loss of neurological function caused by interruption of blood flow to the brain. Motor deficits of hemiplegia , sensory dysfunction , balance impairment , communication disorder , visual field defect , cognitive impairment are the symptom of CVA . 

Balance impairment can be direct effect of CVA as well as strength deficit post CVA these deficit often lead to significant difficulty completing activity of daily living ( ADLs) after extensive rehabilitation up to 50% of stroke survivors experience lingering motor problem and balance problem . This balance impairment is the cause of high risk of fall in this population it is reported that stroke patients are  at high  risk of fall with 1.3 – 6.5 fall / person / year occurring and highest rates, 8.7 falls / person / year , occurring after discharge from hospital . Fall may lead to increased fear of falling , fracture which further cause activity restriction and hence depression .

Most of the rehabilitation in stroke patients revolves around functional retraining along with balance and gait .  trunk musculature weakness can affect balance , stability and functional abilities Jung – Hyun Kim et .al. studied the effect of balance training on hemiplegic stroke patients and have stated that stroke impairs trunk control which is required during weight shifting and equilibrium reaction training for trunk control and balance involve core stability exercise , strategy training , weight shift.

The ability to stand up from seated position is very important in performing activity of daily living independently .It is also prerequisite for gait study revealed that 37.2% of fall in stroke survivours occurred while changing position from sit to stand . Sit to stand movement is the bridge between static position and dynamic body activity from the biomechanical view and defined as a trasitional movement to upright posture . Galli and co -worker found prolonged sit to stand in ascending phase and different vertical force in people after stroke in comparison with healthy control 

Study on Sit to stand reported a wide variety of testing protocol , including difference in seat height , initial joint angle , foot placement which lead to different kinematics and kinetic people with stroke decreased maximal hip flexion angle during forward transfer of trunk when compared with healthy adult before standing up from a seated position . the inability to achieve full hip extension  and knee extension in lock position with stroke might be related to the weakness of the gluteus maximus and quadriceps femoris muscle.

Unequal GRF between affected and unaffected side .Impairment in muscle strength , postural control , balance were factor previously known that contributed to asymmetrical weight – bearing in patient with stroke all these finding suggested that  balance and weight bearing training were needed for people with stroke to improve their motor function and posture control to gain ability of sit to stand .

Pilates is one technique which is recently gaining more popularity . It help in strengthening and conditioning of the body . This technique aim to improve core stability , balance by strengthening core muscle of body – diaphragm , transverse abdominis , multifidus , pelvis floor presently there is availability of study which show the effect of Pilates exercise on sit to stand in chronic stroke is limited. Purpose of this study was to investigate the effect of Pilates training on balance and sit to stand in chronic stroke patients .

 

 NEED OF STUDY  

Population with stroke impairment who are having balance related difficulties leading to decrease in their confidence and social withdrawal due to fear of fall. Physiological change and other reason such as muscle weakness, strength, atrophy change , muscle tone due to stroke . Trunk muscle weakness can affect balance, stability, functional ability.

Stroke impair trunk control which is required during weight shifting and equilibrium reaction , training for trunk control and core stability exercise, weight shift. Ability to stand up from seated position is very important in ADLs. It is prerequisite for gait . Sit to stand is bridge between static position and dynamic body activity .

 Sit to stand reported a wide variety of testing protocol , including difference in seat height , initial joint angle foot placement which lead different kinematics and kinetic . People with stroke  decreased maximal hip flexion angle  during forward transfer of trunk before standing up from a seated position .

In ability to achieve full hip and knee extension in lock position with stroke might be related to weakness of the gluteus maximus , quadriceps femoris muscle .Unequal GRF between affected and unaffected side , impairment in muscle strength , postural control , balance ,were factor previously known that contributed to asymmetrical weight bearing in stroke patients .

All these finding suggested that balance and weight bearing were needed for people with stroke to improve their motor function and posture control to gain ability of sit to stand. Presently , there is effect of  Pilates exercise on balance and sit to stand is limited .Purpose of this study to investigate the effect of Pilates exercise on balance and sit to stand in chronic stroke patients .

 

 

 
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