| 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
|
|
|
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
|
|
|
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 |