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CTRI Number  CTRI/2025/03/082957 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
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   Effects of targeted trunk training on bed mobility in stroke patients 
Scientific Title of Study   The Impact of Targeted trunk training on bed mobility in stroke patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Indhu M 
Designation  Post graduate  
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Department of neurophysiotherapy, Faculty of physiotherapy, no-1, Ramachandra nagar,porur,chennai-600116

Chennai
TAMIL NADU
600116
India 
Phone  08610846844  
Fax    
Email  indhu224m@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  A Raja Rajeswari 
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Department of NeuroPhysiotherapy, Faculty of Physiotherapy, no-1, Ramachandra nagar,porur,chennai-600116

Chennai
TAMIL NADU
600116
India 
Phone  9866802903  
Fax    
Email  rajarajeswari@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  A Raja Rajeswari 
Designation  Associate Professor And HOD 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Institute of Higher Education and Research, Department of neurophysiotherapy, Faculty of physiotherapy, no-1, Ramachandra nagar,porur,chennai-600116

Chennai
TAMIL NADU
600116
India 
Phone  9866802903  
Fax    
Email  rajarajeswari@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research no.1, Ramachandra nagar, porur, Chennai 60016 Tamil nadu India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Dr Indhu M  Sri Ramachandra Institute of Higher Education and Research  Department of Neurology, 4th floor and 5th floor division B4 A5 D5 Medical centre no 1, Ramachandra nagar, Porur, Chennai 600116
Chennai
TAMIL NADU 
8610846844

indhu224m@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Sri Ramachandra Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy  Passive range of motion exercises Active range of motion exercises Active resisted exercises Ankle pumps Assisted SLR Pelvic rotation Pelvic bridging Unilateral bridging Functional training DURATION- 30 minutes frequency- 10 to 15 reps in 2 sets and once a day  
Intervention  Targeted trunk training  Flexion/rotation of upper trunk Flexion/rotation of lower trunk Retraining active protraction of scapula with activation of oblique abdominal muscles Rolling to prone Activating the oblique abdominal muscles in crook lying Positioning of arm Actively controlling the hemiplegic leg throughout its range of motion Rocking in crook sitting Long sitting with isolated knee extension DURATION- 30 minutes frequency- 10 to 15 reps in 2 sets and once a day 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age group 40 to 70
2.Both male and female
3.First occurrence of stroke
4.Both ischemic and hemorrhagic stroke
5.Hemiparesis (either left or right)
6.Impaired trunk muscle function (Motor Assessment Scale Rolling score less than 3).
 
 
ExclusionCriteria 
Details  1.Cognitive impairments
2.Brainstem or cerebellar lesions
3.Other neurological conditions like Parkinsons and Poliomyelitis
4.Orthopedic conditions like fractures and spinal deformities
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Motor Assessment Scale  At baseline and at 10th day 
 
Secondary Outcome  
Outcome  TimePoints 
Postural Assessment Scale for Stroke  At baseline & at 10th day 
Stroke Rehabiitation Assessment of Movement  At baseline & at 10th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/03/2025 
Date of Study Completion (India) 19/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
Stroke is classically characterized as a neurological deficit attributed to an acute focal injury of the central nervous system by a vascular cause, including cerebral infarction, intra cerebral hemorrhage ,and subarachnoid hemorrhage and is a major cause of disability and death worldwide. People with stroke present with a combination of sensory, motor and cognitive impairments. In 70–80% of stroke patients, sensory, and motor impairments are associated to postural deficits involving balance and trunk control. Stroke generally results in unilateral motor deficit in upper and lower extremity. However, its impact on trunk muscle is extensive due to its architecture. Two main muscle groups are involved in trunk movement: the back extensors and abdominal muscles. Most of the abdominal muscles are attached to an aponeurosis that is connected to Linea Alba. So, the muscles on one side of abdomen rely on stability provided by muscles on other side, especially for trunk rotation. This causes compromise of trunk muscles on nonparetic side also leading to impaired movement.
Patricia M. Davies advocates that trunk is a core component to control upper and lower extremities. Without proper trunk control, movements of limbs can only be performed in primitive and stereotyped manner. Improving trunk control in lying position promotes bed mobility in early stage and also contributes to improved balance, gait and ADL in later stages. Trunk control is essential for movement control and postural balance during functional activities.
Trunk performance is an important predictor of functional outcome after stroke. Trunk function is associated with balance and walking ability in stroke patients, and has also been found to offer a useful predictor of balance and walking ability and activities of daily living (ADL) outcomes. There are several studies showing strong evidence that trunk training is able to improve trunk control, sitting and standing balance, gait and ADL activities. Trunk muscles also contribute for bed mobility like turning in bed and moving in bed. 
Bed mobility is one of the basic functions which have to be achieved before progressing to other functions. It is the first step in making the patient independent by enabling them to move on their own to prevent complications like pressure sores or joint stiffness. Patients who reposition themselves require less assistance from caregivers which enables them to concentrate on other aspects of patient’s care. Improvement in bed mobility gives the patient a sense of accomplishment and a positive mindset during the recovery process. Bed mobility is a component assessed in various stroke outcome measures. However, intervention with focus to improve bed mobility using trunk training is hard to find in the literature. 
We design this study with this focused training to improve bed mobility in stroke patients. This could show significant improvement in bed mobility when compared to other trunk training protocols and conventional physiotherapy
 
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