| CTRI Number |
CTRI/2024/08/071779 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| 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
|
Regaining Balance After a Stroke A Comparison of Exercises |
|
Scientific Title of Study
|
To compare the effects of bridge exercise and swiss ball excercises v/s bobath based trunk excercises to improve trunk control and functional balance in post stroke (hemiplegia) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Lohani |
| 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
UTTARANCHAL
248001
India |
| Phone |
|
| Fax |
|
| Email |
lohanipreeti08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shama Praveen |
| Designation |
Assistant Professor |
| 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
UTTARANCHAL
248001
India |
| Phone |
8006965111 |
| Fax |
|
| Email |
shamapraveen@sgrrmc.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shama Praveen |
| Designation |
Assistant Professor |
| 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
UTTARANCHAL
248001
India |
| Phone |
8006965111 |
| Fax |
|
| Email |
shamapraveen@sgrrmc.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun, Uttarakhand , 248001
India |
|
|
Primary Sponsor
|
| Name |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences pathribagh dehradun |
| Address |
Department of Physiotherapy North Block, Lower Ground Shri
Mahant Indresh Hospital Patel Nagar Dehradun, Uttarakhand, 248001, India |
| 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 |
| Dr Preeti Lohani |
Shri Mahant Indresh Hospital |
Department of Physiotherapy North Block, Lower Ground Shri
Mahant Indresh Hospital Patel Nagar Dehradun
Dehradun
UTTARANCHAL |
7252927804
lohanipreeti08@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, Uttrakhand |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bobath based trunk exercises |
Group B in the study will focus on Bobath-based trunk exercises designed to improve trunk control and functional balance in individuals post-stroke. These exercises are structured to address specific rehabilitation goals, starting with Exercise 1, which involves stretching contracted muscles to improve range of motion. Exercise 2 focuses on body weight transfer exercises to enhance weight shifting abilities. Exercise 3 includes sit-to-stand exercises aimed at improving functional mobility. Conversely, Exercise 4 concentrates on stand-to-sit maneuvers to enhance controlled lowering movements.
Exercise 5 aims to promote trunk extension, fostering greater postural control. Exercise 6 emphasizes the training of lumbar spine stabilizers through pelvic bridging exercises, supporting core strength. Exercise 7, functional reach out, focuses on expanding the range of upper body movements. Lastly, Exercise 8 introduces rotation and counter-rotation activities to enhance rotational stability and overall balance. Each session is designed to last approximately 40 minutes, conducted 6 days a week, once a day, over a period of 6 weeks. These exercises are tailored to evaluate their efficacy in enhancing trunk control and functional balance recovery among individuals recovering from hemiplegia due to stroke, utilizing the principles of the Bobath concept in neurorehabilitation |
| Intervention |
Bridge exercise Swiss Ball exercise |
Group A in the study will engage in a variety of exercises aimed at improving trunk control and balance post-stroke. The first set of exercises includes the Supine Bridge Exercise, where participants will lie on their backs with knees bent at a 90-degree angle and arms extended at a 30-degree angle on the ground. They will maintain a straight head and neck position, looking towards the ceiling, and hold each repetition for 7 seconds followed by a 3-second rest. This exercise will be performed for 3 sets of 10 repetitions, once a day, 6 days a week, over a period of 6 weeks.
The second set of exercises involves Swiss Ball Exercises, which encompass a comprehensive range of movements targeting different aspects of trunk and core stability. These include Upper and Lower trunk rotations, Sitting exercises such as trunk flexion and extension, static sitting balance, rocking, and bending exercises with clasped hands, as well as Standing exercises like Wall squats, Wall squats with knee extension and bending. Prone exercises will also be included, such as Swiss ball opposite arm and leg lifts and back extensions with abdomen supported on the ball or T-raise. Additionally, core stability enhancing exercises and balance exercises will be incorporated. Each segment of Swiss Ball Exercises will consist of 10 repetitions for 3 sets, totaling approximately 40 minutes per session. This regimen will also be conducted 6 days a week, once a day, over the course of 6 weeks. These exercises aim to evaluate their effectiveness in enhancing functional balance and trunk control among individuals recovering from hemiplegia due to stroke. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects Age below 75 years
2. Both gender male or female
3. Patients with haemorrhagic stroke( left or right side) .
4. Patients is in acute or sub-acute phase (at least 6 months but not more than 2 years earlier)
5. Cardiovascular stability
6. Berg Balance Scale score greater than 20
7. MAS should be 1, 1 plus or 2
|
|
| ExclusionCriteria |
| Details |
1. Head injury
2. Brain tumor
3. With any Contraindication to start rehabilitation ( Uncontrolled Hypertension,Diabetes)
4. Unable to communicate or unable to follow commands
5. Those with history of any Neurological deficit other than stroke
|
|
|
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
6th week data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trunk impairment scale |
Baseline Data
6th week Data |
| TUG Test |
Baseline Data
6th Week Data |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2024 |
| 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
|
The research aims to compare the effectiveness of two different exercise regimens in improving trunk control and functional balance in individuals post-stroke (hemiplegia). A total of 42 patients will participate in the study, selected through convenient sampling from Shri Mahant Indiresh Hospital, specifically from the Department of Physiotherapy and Neurology Ward in Patel Nagar, Dehradun. The study will consist of two groups: - Group A: 21 patients who will undergo Bridge exercises and Swiss ball exercises.
- Group B: 21 patients who will receive Bobath-based trunk exercises.
Patients will be selected based on specific inclusion and exclusion criteria, and informed consent will be obtained from each participant. Detailed explanations about the study’s purpose and procedures will also be provided to the subjects and their families prior to enrollment. The research aims to evaluate and compare the outcomes of these different exercise interventions on trunk control and functional balance recovery in individuals recovering from hemiplegia caused by stroke. |