CTRI

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CTRI Number

CTRI/2025/07/090116 [Registered on: 03/07/2025] Trial Registered Prospectively

Last Modified On:

03/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Other (Specify) [Occupational Therapy]

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Using Everyday Activities to Improve Arm Movement and Daily Life in People Recovering from Stroke with One-Sided Paralysis.

Scientific Title of Study

Effectiveness of Occupation based activity training on Functional Task Performance of Upper Extremity and Quality of Life among individuals with Hemiplegic Stroke.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Shreyasi Sarkar
Designation	PG Student
Affiliation	Chettinad School of Occupational Therapy
Address	A block, ward no 24,OT in neurology department, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam Chennai TAMIL NADU 603103 India
Phone	9910410156
Fax
Email	shreyasi.sarkar9771@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vignesh
Designation	Asst Professor
Affiliation	Chettinad School of Occupational Therapy
Address	A block, ward no 24,OT in neurology department, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam A block, ward no 24,OT in neurology department, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam Chennai TAMIL NADU 603103 India
Phone	9910410156
Fax
Email	n.vignesh789@gmail.com

Details of Contact Person
Public Query

Name	Shreyasi Sarkar
Designation	PG Student
Affiliation	Chettinad School of Occupational Therapy
Address	A block, ward no 24,OT in neurology department Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam A block, ward no 24,OT in neurology department Chettinad Academy of Research and Education, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam Chennai TAMIL NADU 603103 India
Phone	8777596720
Fax
Email	shreyasi.sarkar9771@gmail.com

Source of Monetary or Material Support

OT Neurology Division, Ward No. 24 , Department of Occupational therapy, Chettinad General Hospital, Chettinad Health City, Rajiv Gandhi Salai, OMR, Kelambakkam, Tamilnadu- 603103

Room No. 24, General Occupational therapy Department,National Institute for Empowerment of Persons with Multiple Disabilities (Divyangjan),East Coast Road, Muttukadu, Kovalam Post Chennai , Tamil Nadu, India - 603112.

Primary Sponsor

Name	Shreyasi Sarkar
Address	Chettinad Academy of Research and Education, Chettinad Health City, Rjiv Gandhi Salai, OMR, Kelambakkam, TamiilNadu-603103
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
Dr Vignesh N	Chettinad General Hospital	Ot Neurology Division, Ward. No. 24, Department of Occuptional Therapy,Chettinad Genereal Hospital, Chettinad Health City, Rajiv Gandhi Salai (OMR), Kelambakkam, Chennai, Tamil Nadu-603103 Chennai TAMIL NADU	9750122121 n.vignesh789@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Human Ethics Committee for Student Research (CARE IHEC - I)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I639\|\|Cerebral infarction, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Chedoke Arm and Hand Inventory (CAHAI) Stroke-Specific Quality of Life (SS-QOL) Scale	The effect of the Intervention will be assessed by comparing the result of Pre Test collected in the begining and the Post Test after completing the 2 months intervention period.
Intervention	Occupation based activity training	The Subjects will Participate in Occupation Based Activity Training for 2 months. Intervention will focuse on improvingFunctional Task Performance of Upper Extremity and Quality of Life. Each Session will lasts 45 minutes and will be 6 times a week .There will be a total of 48 sessions.

Inclusion Criteria

Age From	40.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Hemiplegic patients with 40-65 years of age. Both male and female genders. Diagnosed with hemiplegic stroke (post-stroke duration more than 3 months) a stage of over 3 in Brunnstrom recovery staging for the affected upper limb Fugl Meyer assessment upper extremity score between of 19 – 40. Modified Ashworth scale score less than 2 in all upper limb muscles.

ExclusionCriteria

Details

Perceptual disorder,
Recurrent stroke,
Symptomatic cardiac failure,
Shoulder dislocation,
Uncorrectable vision problems,
Patients with other neurological disorder/musculoskeletal problems

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Chedoke Arm and Hand Inventory (CAHAI) Stroke-Specific Quality of Life (SS-QOL) Scale	6 days/week for 4 weeks, 45 minutes/session

Secondary Outcome

Outcome	TimePoints
nil	nil

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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)

01/09/2025

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="2"
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

The study will begin with the recruitment of participants from NIEPMD and Chettinad Hospital and Research Institute. After providing a detailed explanation of the study, informed consent will be obtained from the participants. All individuals undergo an initial screening process using the Fugl-Meyer Assessment (FMA) Scale. Only participants with moderate to mild upper limb impairment post-stroke (as per FMA scores) are included in the study (n=x). From this, 60 eligible participants will be selected through convenient sampling. These participants will be randomly allocated into two groups: Group A and Group B. Group A will receive a Occupational based activity training intervention. Before the intervention, a baseline assessment using the Chedoke Arm and Hand Inventory (CAHAI) and Stroke Specific- Quality of Life (SS-QOL) will be conducted. Following this, participants in Group A will undergo a 4-week Occupational based activity intervention. After the intervention period, a post-intervention CAHAI and SS-QOL assessment will be performed. Group B will serve as the control group and continue with their usual routine. Similar to Group A, a baseline CAHAI and SS-QOL assessment will be carried out before the intervention period. Participants will then continue their regular routine for the duration of the study, after which a post-intervention CAHAI and SS-QOL assessment will be conducted. Finally, data from both groups will be analyzed using SPSS statistical software to evaluate the outcome of the intervention.