| CTRI Number |
CTRI/2024/07/071454 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| 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 core strengthening and task oriented exercise with conventional therapy in improving balance and function in stroke patient |
|
Scientific Title of Study
|
To compare the effect of core strengthening with conventional therapy versus task oriented exercise with conventional therapy in improving balance and function in stroke. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Rawat |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Room No-03, Department of Physiotherapy, North Block, Lower
Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9927687966 |
| Fax |
|
| Email |
divyarawat808@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shama Praveen PT |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement
Dehradun
UTTARANCHAL
248001
India
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8006965111 |
| Fax |
|
| Email |
shamapraveen@sgrrmc.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shama Praveen PT |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement
Dehradun
UTTARANCHAL
248001
India
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8006965111 |
| Fax |
|
| Email |
shamapraveen@sgrrmc.com |
|
|
Source of Monetary or Material Support
|
| Shri Mahant Indresh Hospital, Patel Nagar, Dehradun, Uttrakhand, 248001 |
|
|
Primary Sponsor
|
| Name |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Department of Physiotherapy North Block, Lower Ground Shri
Mahant Indresh Hospital Patel Nagar Dehradun |
| Type of Sponsor |
Private medical 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 |
| Divya Rawat |
Shri Mahant Indresh Hospital |
Department of
physiotherapy, North
Block, Lower Ground,
Patel Nagar, dehradun
Dehradun
UTTARANCHAL |
9927687966
divyarawat808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G839||Paralytic syndrome, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core strengthening with conventional therapy |
In this study, two distinct exercise protocols have been implemented to address different aspects of rehabilitation for the participants. Exercise 1 focuses on core strengthening through targeted exercises including pelvic control exercises, bridging exercises, curl-ups, and side bridging exercises. These exercises are intended to bolster the stability and strength of the core muscles, which play a crucial role in supporting the spine and maintaining overall body posture and movement. On the other hand, Exercise 2 involves conventional therapy techniques such as range of motion exercises, mobility exercises, and stretching. These exercises are aimed at improving joint flexibility, enhancing overall mobility, and reducing muscle tension and stiffness. Both exercise protocols are integral components of rehabilitation programs, each targeting specific aspects of physical recovery and functional improvement for the participants involved in the study. Group will receive the treatment for 6 days per week for 8 weeks.
Time duration for each session will be 40 minutes |
| Comparator Agent |
Task oriented exercises with conventional therapy |
Group B will engage in a comprehensive program combining task-oriented exercises with conventional therapy techniques to enhance their rehabilitation outcomes. Exercise 1 focuses on heel lifts, performed in repetitions to improve lower limb strength and coordination. Exercise 2 involves both unilateral and bilateral slow arm movements, along with slow forward and backward walking, aimed at enhancing upper body control and gait stability. Exercise 3 challenges participants with a walking task covering 3 meters, including turning around a designated point and returning, to improve spatial awareness and mobility. Exercise 4 targets functional mobility by practicing standing up from a chair, which promotes lower limb strength and independence in daily activities.
Exercise 5 introduces a coordination challenge where patients hold a ball in their unaffected hand while performing reaching and grasping movements, enhancing upper limb coordination and dexterity. Exercise 6 further challenges balance and coordination by performing similar reaching and grasping tasks while standing on a balance board, integrating proprioception and stability training. Finally, Exercise 7 includes conventional therapy components such as range of motion exercises, mobility drills, and stretching, which are essential for maintaining joint flexibility, reducing muscle tightness, and optimizing overall physical function. This combined approach aims to provide a holistic rehabilitation regimen that addresses both specific functional tasks and foundational physical abilities crucial for post-injury recovery and improved quality of life. Group will receive the treatment for 6 days per week for 8 weeks.
Time duration for each session will be 40 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1- Age below 65 years.
2- Both genders male and female.
3- Patient with a history of first-time stroke.
4- Patient who achieved sitting for at least 10s.
5- Patient who have acute and subacute ischemic stroke.
6- Patient who had a definite diagnosis of stroke confirmed through CT
or MRI. |
|
| ExclusionCriteria |
| Details |
1- Age above 65years.
2- Unable to communicate and unable to follow commands.
3- Patient who are paralyzed on both sides (Quadriplegia).
4- Any visual, sensory and hearing impairment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg Balance Scale |
Baseline Data
Mid Week Data
Post Intervention Data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trunk Impairment Scale |
Baseline Data
Mid Week Data
Post Intervention Data |
| Stroke Specific Quality Of Life |
Baseline Data
Mid Week Data
Post Intervention Data |
| Timed Up and Go test |
Baseline Data
Mid Week Data
Post Intervention Data |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
07/08/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|