| 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
|
|
|
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
|
|
|
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 .
|