CTRI

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CTRI Number

CTRI/2024/05/067811 [Registered on: 22/05/2024] Trial Registered Prospectively

Last Modified On:

22/05/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Comparison of joint position sense of hand between people with stroke and without stroke using a robotic device

Scientific Title of Study

Comparison of Hand Proprioception between People with Stroke and Age-Matched Adults using End-Effector Robotic Device

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Modi Bhavya Chetankumar
Designation	PG student
Affiliation	Manipal College of Health Professionals, Manipal Academy of higher education, Manipal
Address	Room number 215, Department of physiotherapy, second floor, Manipal College of Health Professionals, Manipal Academy of higher education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104 Udupi KARNATAKA 576104 India
Phone	6355317475
Fax
Email	modi.mchpmpl2023@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr John Solomon M
Designation	Additional Professor, HOD of department of Physiotherapy, MCHP, MAHE, Manipal
Affiliation	Manipal College of Health Professionals, Manipal Academy of higher education
Address	Room number 215, Department of physiotherapy, second floor, Manipal College of Health Professionals, Manipal Academy of higher education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104 Udupi KARNATAKA 576104 India
Phone	9945670671
Fax
Email	john.solomon@manipal.edu

Details of Contact Person
Public Query

Name	Dr Manikandan Natarajan
Designation	Additional Professor
Affiliation	Manipal College of Health Professionals, Manipal Academy of higher education
Address	Room number 215, Department of physiotherapy, second floor, Manipal College of Health Professionals, Manipal Academy of higher education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104 Udupi KARNATAKA 576104 India
Phone	9886898064
Fax
Email	mani.kandan@manipal.edu

Source of Monetary or Material Support

Department of Physiotherapy, Manipal College of Health Professionals, Manipal Academy of higher education, Manipal, Udupi, Karnataka, India- 576104

Primary Sponsor

Name	Modi Bhavya Chetankumar
Address	Department of Physiotherapy, Manipal College of Health Professionals, Manipal Academy of higher education, Manipal, Udupi, Karnataka- 576104
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 John Solomon M	Kasturba Hospital	102 N1 Physiotherapy OPD, Baliga Block, Kasturba Hospital, Madhav Nagar Manipal, Udupi, Karnataka. Udupi KARNATAKA	9945670671 john.solomon@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2	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
Intervention	NIL	NIL
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	People with Stroke- People with first onset of ischemic or hemorrhagic stroke (weakness of one side) and duration less than 3 months from onset of stroke. Cognitively and medically stable. Healthy Individuals- Age-Matched Healthy Individuals

ExclusionCriteria

Details

People with Stroke-
Presence of other neurological conditions.
Severe spasticity, tightness or deformity in hand.
Pain or any other condition that results in inability to open the hand or difficult to attach robot to hand.
Perceptual deficits like hemineglect, finger agnosia or anosognosia.

Healthy Individuals-
Pain in hand (VAS score more than 3), oedema or any deformity of hand
Recent injury or surgery to hand (duration less than 6 months)
Professionals involved in fine motor activities of hand (E.g. artists playing string instruments, piano)

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Sense of Repositioning	Onetime assessment will be done at the time of recruitment only.

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="20"

Phase of Trial

N/A

Date of First Enrollment (India)

03/06/2024

Date of Study Completion (India)

25/03/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="11"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Completed

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

This study procedure involves comparing joint position sense of hand between people with stroke and age-matched healthy individuals using end-effector robotic device. Participants will be made to sit comfortably on a chair with arm rest in front of and close to the robotic device. Their forearm will be placed on the cushioned arm rest of the device and strapped. Assessment of joint position sense of hand will be done by the device in following 3 positions- 1) lumbrical grip position 2) thumb with index finger 3) thumb with lateral 3 fingers. After the familiar trial, this experiment will be repeated for 3 trials. An average of 3 trials will be considered for analysis. The data obtained will be stored and analyzed.