CTRI

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CTRI Number

CTRI/2023/10/058949 [Registered on: 20/10/2023] Trial Registered Prospectively

Last Modified On:

13/10/2023

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 study the effect of Graded motor imagery technique versus Task oriented training on hand function in person with post stroke paralysis.

Scientific Title of Study

Effect of Graded motor imagery technique versus Task oriented training on hand function among individual with post stroke â€“ A Comparative study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dhwani Suthar
Designation	MPT Scholar
Affiliation	PARUL INSTITUTE OF PHYSIOTHERAPY
Address	B402 Gunatit residency , opposite gayatri school , gotri , vadodara Vadodara GUJARAT 391101 India
Phone	9173142160
Fax
Email	dhwanisuthar2016@gmail.com

Details of Contact Person
Scientific Query

Name	Dr JOYAL TEJPAL
Designation	ASSISTANT PROFESSOR
Affiliation	PARUL INSTITUTE OF PHYSIOTHERAPY
Address	405 pg room ,PARUL INSTITUTE OF PHYSIOTHERAPY , PARUL UNIVERSITY , WAGHODIA , VADODARA Vadodara GUJARAT 391760 India
Phone	9909981454
Fax
Email	joyal.tejpal25384@paruluniversity.ac.in

Details of Contact Person
Public Query

Name	Dr JOYAL TEJPAL
Designation	ASSISTANT PROFESSOR
Affiliation	PARUL INSTITUTE OF PHYSIOTHERAPY
Address	405 pg room ,PARUL INSTITUTE OF PHYSIOTHERAPY , PARUL UNIVERSITY , WAGHODIA , VADODARA Vadodara GUJARAT 391760 India
Phone	9909981454
Fax
Email	joyal.tejpal25384@paruluniversity.ac.in

Source of Monetary or Material Support

PARUL SEVASHRAM HOSPITAL

Primary Sponsor

Name	DHWANI SUTHAR
Address	Pg room 405, parul institute of physiotherapy , parul university, vadodara
Type of Sponsor	Other [Self]

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
DHWANI SUTHAR	PARUL SEVASHRAM HOSPITAL	PARUL SEVASHRAM HOSPITAL , PARUL UNIVERSITY, WAGHODIA Vadodara GUJARAT	9173142160 dhwanisuthar2016@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
PARUL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G819\|\|Hemiplegia, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Graded motor imagery	1 Laterality recognition Photographs will be displayed in different postures of hand and will be asked to identify .The random presentation of 25 images of hands will be oriented in various positions and degrees of rotation displayed. For each image, the patients will be required to choose side of hand.Practice session, using 20 images in beginning .Then actual IMI task will be start. Accuracy and reaction times of responses will recorded by Orientate application using an smartphone .Patient performs in the test with non affected hand . Each session, the patients will complete IMI task for at least four times within the hour of treatment until the patient achieved accuracy and reaction time (i.e. accuracy â‰¥80%). 2 Explicit Motor Imagery - Patients, will be sitting in a relaxed position, with close their eyes and imagining themselves sitting in a familiar place. They will be asked to execute the movement as if in real in all its aspects, including the timing taken to move. Images from the IMI stage will be asked for imagining movements. Patients will executed 2 series of 20 repetitions for every imagined movement in each session. 3 Mirror therapy-In Mirror therapy section of GMI visual feedbacks will be provided placing a mirror in front of the subject, on midline, so that when the patient looks into the mirror can see unaffected limb reflected. Mirror exercises will began with simply watching the reflection of the unaffected hand in the mirror and then it will be progressed from static to active movements with 3 series.
Intervention	Task oriented training	Therapy included following functional tasks; reaching, grasping or holding, lifting, placing objects. functional tasks will be practiced through task-oriented exercises by performing simple activities of daily living such as eating (using a cup and spoon), dressing (wearing and taking off a shirt), using a belt, pour water to other glass, clean surface with cloth ,close buttons , open zippers , lifting glass to drink water , staking cups. Each of these activities will be performed for 5 repetitions. Tasks will be performed with the participants seating in front of the table placed at a suitable height where objects related to the intervention are arranged. The level of difficulty to the patient will be increased slowly day by day by assigning the tasks above the patientâ€™s capacity and by increasing the distance between the object by which task should be carried out and reducing the size of the object and by decreasing the time to carry out a task. A rest interval of 5mins will be given whenever it is required by the patient in one exercise period. Exercise will be performed for 45 minutes per day for 4 week 5 days a week.

Inclusion Criteria

Age From	30.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Age below 60 years. Patients with subacute stroke. First episode of stroke. Brunnstorm grade 3 onwards. MMSE > 24 (mini mental state examination)

ExclusionCriteria

Details

Patients with shoulder subluxation or Upper limb contracture.
Patients with musculoskeletal problems.
Peripheral neuropathy.
Severe spasticity with modified Ashworth scale .
Visual and auditory impairment.

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Alternation

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Box and Block test	Before and after 4 weeks of treatment

Secondary Outcome

Outcome	TimePoints
Jebson Taylor hand function test	Before and After 4 weeks of treatment

Target Sample Size

Total Sample Size="82"
Sample Size from India="82"
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

N/A

Date of First Enrollment (India)

30/10/2023

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="6"
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

Effect of Graded motor imagery technique versus Task oriented training on hand function among individual with post stroke â€“ A Comparative study.

NEED OF STUDY

Impaired hand function is most common frequently persisting consequences of stroke. Therefore it is important to improve hand function in order to make patient independent in his functional activity. Many studies have been proved Task oriented training is effective as specific motor task is given to perform movement .It is simple movement to improve functional activities which are used in Activities of daily living (ADL).It can even be performed by patient at home as no equipment is needed. Graded motor imagery is a set of treatment improve the ability of hand function . It consists of three specific elements which activates the cortical networks. Both have beneficial effect on stroke. Hence the purpose, of this study is to compare the effect of task oriented training and graded motor imagery.