| CTRI Number |
CTRI/2024/04/065079 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| 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
|
To Compare the effect of electrical brain stimulation versus electrical stimulation on improving hand function in stroke |
|
Scientific Title of Study
|
Effectiveness of repetitive trans-cranial magnetic stimulation versus electrical stimulation in improving hand function after stroke - A randomized control trial |
| 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 Geetanjali Saggar |
| Designation |
Assistant professor |
| Affiliation |
Lovely professional university |
| Address |
Department of Physiotherapy ,block 4 , room no 213-CH12, School of Allied Medical Sciences, Lovely Professional University , Phagwara-144411 Punjab,India.
Jalandhar
PUNJAB
144411
India |
| Phone |
8427509407 |
| Fax |
|
| Email |
Geetanjalisaggar11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parneet kaur |
| Designation |
MPT Neurology PG student |
| Affiliation |
Lovely professional university |
| Address |
Department of Physiotherapy, block 3 , room no 105 , school of Allied Medical Sciences, lovely Professional University, Phagwara -144411, Punjab , India
Jalandhar
PUNJAB
144411
India |
| Phone |
8264608043 |
| Fax |
|
| Email |
Pkaur789778@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Saggar |
| Designation |
Assistant professor |
| Affiliation |
Lovely professional university |
| Address |
Department of Physiotherapy ,block 4 , room no 213-CH12, School of Allied Medical Sciences, Lovely Professional University , Phagwara-144411 Punjab,India.
Jalandhar
PUNJAB
144411
India |
| Phone |
8427509407 |
| Fax |
|
| Email |
Geetanjalisaggar11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, block 3 , room no 105 , school of allied medical sciences, lovely professional university, Phagwara -144411, Punjab , India |
|
|
Primary Sponsor
|
| Name |
Dr Geetanjali Saggar |
| Address |
Department of physiotherapy ,block 4 , room no 213-CH12, School of allied medical sciences, Lovely professional university , Phagwara-144411 Punjab,India. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Parneet kaur |
Shrimann Hospital |
Physiotherapy Opd,Ground floor, Pathankot road,jalandhar,punjab,144012,india
Jalandhar
PUNJAB |
8264608043
pkaur789778@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University(IEC-LPU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G460||Middle cerebral artery syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Electrical muscle stimulation with Conventional physiotherapy |
2 month duration, 3 alternative days a week for 30 minutes |
| Intervention |
Repetitive trans-cranial magnetic
stimulation with
Conventional physiotherapy |
2 month duration, 3 alternative days a week for 40 minutes |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 45 or above
2.Patients able to understand commands
3.Both Male and female
4.Individuals with Clinical diagnosis of stroke
5.Individuals with impaired hand function from stroke. |
|
| ExclusionCriteria |
| Details |
1.Hand deformities.
2.Hand impairment due to nerve injury,brachial plexus injury.
3.Epileptic patient, cardiac conditions and psychological disorders.
4.Orthopeadic condition ((fractures of
hand and wrist).
5.Uncooperative patients or unconscious
patient |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Fugl Meyer Assessment for
Upper extremity scale
2. Wolf Motor Function test |
baseline,week4 and study completion week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Modified Ashworth scale(MAS)
2. Hand Dynamometer |
baseline,week4 and study completion week 8 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
13/04/2024 |
| 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 Applicable |
| 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
|
Stroke often leads to significant impairment of upper limb function and is associated with decreased quality of life in all domains. Hand function is most difficult and later to be achieved, very few studies has been done on improvement in hand motor function with electro-therapy. This study will be helpful in knowing the effectiveness of rams in comparison with electrical muscle stimulation. This study may help to rule out the future most effective electrical therapy management of Stroke patients with hand function limitation who are particularly susceptible to problems in performing daily living. Several treatment options are available for patients after stroke, with varying levels of evidence, but with this study we will be able to know which is best and less time consuming modality to regain hand function. Aim of the study To find “effectiveness of repetitive trans-cranial electrical stimulation versus electrical stimulation in improving hand function after stroke†Objectives 1. To identify the effectiveness of rtms in comparison to electrical stimulator in upper limb dysfunction 2. .Measure and compare the extent of functional improvements in the hand function for stroke patients undergoing Rtms and electrical stimulation 3. Evaluate and compare the impact of both interventions on motor recovery in affected hand. A total of 30 subjects will participate in the study. The participants would be enlisted with physician referral having mild to moderate hand impairment after stroke. A proper neurological cardio-respiratory will be taken prior to study with proper safety and precautions to avoid any unwanted injury or damage during the procedure. Group A will be given RTMS coupled with conventional exercises for 3 alternative days a week about 40 minutes total session. In Group B electrical stimulation and exercises for about 40- minutes will be given. Hand function will be assessed with outcome measures like Fugl Meyer upper extremity scale, box and block test and wolf motor function and hand strength with hand dynamometer will be measured. All assessment will be taken before the treatment during 20 days of treatment and at post completion of the treatment |