CTRI Number |
CTRI/2018/08/015323 [Registered on: 13/08/2018] Trial Registered Prospectively |
Last Modified On: |
09/07/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Checking the effect of specific strengthening of core muscles in addition to regular trunk physiotherapy program on the ability to detect the trunk position sense and ability to move around in surrounding |
Scientific Title of Study
|
Effect of core muscle strengthening on trunk proprioception and functional mobility in persons with chronic stroke |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vimal Telang |
Designation |
Lecturer Physiotherapy |
Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
Address |
All India Institute of Physical Medicine and Rehabilitation,
K.Khadye Marg,
Haji Ali,
Mahalaxmi,
Mumbai.
Mumbai MAHARASHTRA 400034 India |
Phone |
9869175668 |
Fax |
|
Email |
vimaltelang@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Vimal Telang |
Designation |
Lecturer Physiotherapy |
Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
Address |
All India Institute of Physical Medicine and Rehabilitation,
K.Khadye Marg,
Haji Ali,
Mahalaxmi,
Mumbai.
Mumbai MAHARASHTRA 400034 India |
Phone |
9869175668 |
Fax |
|
Email |
vimaltelang@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Vimal Telang |
Designation |
Lecturer Physiotherapy |
Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
Address |
All India Institute of Physical Medicine and Rehabilitation,
K.Khadye Marg,
Haji Ali,
Mahalaxmi,
Mumbai.
Mumbai MAHARASHTRA 400034 India |
Phone |
9869175668 |
Fax |
|
Email |
vimaltelang@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Physical Medicine & Rehabilitation,Mumbai. |
|
Primary Sponsor
|
Name |
Vimal Telang |
Address |
All India Institute of Physical Medicine and Rehabilitation,
K.Khadye Marg,
Haji Ali,
Mahalaxmi,
Mumbai.400034 |
Type of Sponsor |
Other [SELF] |
|
Details of Secondary Sponsor
|
Name |
Address |
Divyarani Savant |
All India Institute of Physical Medicine and Rehabilitation,
K.Khadye Marg,
Haji Ali,
Mahalaxmi,
Mumbai 400034. |
Sheik Abdul Khadir AMK |
All India Institute of Physical Medicine and Rehabilitation,
K.Khadye Marg,
Haji Ali,
Mahalaxmi,
Mumbai 400034. |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
VIMAL TELANG |
All India Institute of Physical Medicine and Rehabilitation |
All India Institute of Physical Medicine and Rehabilitation,
K.KHADYE MARG, HAJI ALI, MAHALAXMI, MUMBAI. 400 034. Mumbai MAHARASHTRA |
9869175668
vimaltelang@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committe, AIIPMR |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, (2) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
CONTROL GROUP |
conventional therapy mainly of stretching, facilitation /strengthening of movement as required for the hemiparetic side, task oriented activities with altered sensory input for balance and gait for 6 weeks (3times/week) |
Intervention |
EXPERIMENTAL GROUP |
core muscle strengthening training PLUS conventional therapy mainly of stretching, facilitation /strengthening of movement as required for the hemiparetic side, task oriented activities with altered sensory input for balance and gait for 6 weeks (3times/week) |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
1) First onset of unilateral hemorrhagic or ischemic stroke;
2) Onset of Stroke for >6mths
3) Who is able to understand and follow simple verbal instruction, scoring at least 24 out of 30 on Mini Mental State Examination
4) Brunnstrom’s recovery stage of 5 or above for the lower limb thus ensuring that excessive spasticity and lower limb basic synergy patterns are not causing balance impairments (32) .
5) Berg Balance Score of 40 or above , ensuring a higher level of static balance .(33)
6) Who able to walk independently for at least 10 m with or without walking aid.
|
|
ExclusionCriteria |
Details |
1) Uncontrolled vitals
2) Neurological disease affecting balance other than stroke such as Parkinson’s disease, traumatic brain injury etc
3) somato-sensory deficits, apraxia, and hemineglect.
4) Presence of visual problems like homonymous hemianopsia
5) Vertigo, vestibular disorders
6) History of joint deformity, pain in joints which would interfere with motor performance.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.Trunk repositioning error at an angle of 30 degree flexion
2.The six metre walk test
3.The sit to stand test with five repetitions,
4.The alternate step test
5.The stair ascent and descent tests. |
All the subjects will be assessed for the outcome measures at induction in the study and after 6 weeks of therapy protocol and at 10thweek for follow up of carry over effects |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Trunk repositioning error at an angle of 30 degree flexion
2.The six metre walk test
3.The sit to stand test with five repetitions,
4.The alternate step test
5.The stair ascent and descent tests. |
All the subjects will be assessed for the outcome measures at induction in the study and after 6 weeks of therapy protocol and at 10thweek for follow up of carry over effects |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
16/08/2018 |
Date of Study Completion (India) |
28/02/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Telang, Vimal Mahendra; Savant, Divyarani; Khadir, A. M. K. Sheik Abdul. Effect of core muscle strengthening on trunk proprioception and functional mobility in persons with chronic stroke. Physiotherapy - The Journal of Indian Association of Physiotherapists 19(1):p 31-37, Jan–Jun 2025. | DOI: 10.4103/pjiap.pjiap_180_24 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Core Muscles are described to provide proximal stability for distal mobility. Two types of muscle fibers comprise the core muscles: slow-twitch and fast-twitch.
The core acts through the thoracolumbar fascia, ‘‘nature’s back belt.’’ The transversus abdominis has large attachments to the middle and posterior layers of the thoracolumbar fascia (Bogduk,1997). Additionally, the deep lamina of the posterior layer attaches to the lumbar spinous processes. In essence, the thoracolumbar fascia serves as part of a ‘‘hoop’’ around the trunk (McGill,2002) that provides a connection between the lower limb and the upper limb (Vleeming et al,1995). With the contraction of the muscular contents, the thoracolumbar fascia also functions as a proprioceptor, providing feedback about trunk positioning.
The intertransversariimediales, interspinales, and rotatores are extremely close to the centre of rotation of the spinal segments. Their very small physiological cross-sectional area and their high density of muscle spindles (4.5-7.3 times richer than the number in the multifidus) suggests that they may act primarily as position transducers of the spinal column .This would suggest that these LSS Muscles would appear to be particularly important to the coordination required in Core Stability (Wendell et al,1995).
A randomized controlled trial Rosa Cabanas-Valdés et al (2007) on Core stability exercises in addition to conventional therapy improved trunk control, dynamic sitting balance, standing balance, gait and activities of daily living in sub-acute post-stroke patients. Also, additional trunk exercises (Van Criekingeet al 2017) showed the effectiveness of on gait performance in subacute stroke. However the duration of onset in their experimental group was 25.12 (17.30) days a time when recovery can be attributed partly to natural and therapeutic reasons. Following intervention, Eun-Jung Chung et al (2013) reported in chronic stroke the core exercise group showed a significant change in TUG, velocity, and cadence. XiboSun, et al (2016) reported that Core stability exercises have a better effect on patients with hemiplegia than conventional exercises.
Review of literature on effect of core muscle strengthening on the trunk proprioception and functional mobility in chronic stroke is meagre. Hence this study focuses on evaluating the therapeutic effect of core muscle strengthening exercises in addition to the conventional trunk physiotherapy program on trunk proprioception and functional mobility in persons with chronic stroke.
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