| CTRI Number |
CTRI/2024/04/066022 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To know how accurate 2D video measures the arm reach-to-grasp-to-mouth task. And, to see if 2D is as precise and dependable as 3D. |
|
Scientific Title of Study
|
Validity and Reliability of 2D video-based kinematic assessment of upper extremity reach-to-grasp-to-mouth task in persons with stroke. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Misalankar |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions,Manipal Academy of higher education, Manipal |
| Address |
Room 215, Department of Physiotherapy, second floor, Manipal College of Health Professions,Manipal Academy of higher education,Madhav nagar, Manipal, Udupi-Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7022124205 |
| Fax |
|
| Email |
nidhi2.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil Kumaran D |
| Designation |
Additional Professor of Physiotherapy |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of higher education, Manipal |
| Address |
Room 215, Department of Physiotherapy, second floor, Manipal College of Health Professions,Manipal Academy of higher education,Madhav nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9986910303 |
| Fax |
|
| Email |
senthil.kumaran@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr John Solomon M |
| Designation |
Professor, Head of the Department of Physiotherapy |
| Affiliation |
Manipal College of Health Professions,Manipal Academy of higher education, Manipal |
| Address |
Room 215, Department of Physiotherapy, second floor, Manipal College of Health Professions,Manipal Academy of higher education,Madhav nagar, Manipal, Udupi-Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9945670671 |
| Fax |
|
| Email |
john.solomon@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal,Udupi,Karnataka |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions,Manipal Academy of Higher Education,Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nidhi Misalankar |
Kasturba Hospital |
Neuromotor Control room, 3rd floor, Kasturba Hospital, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
7022124205
nidhi2.mchpmpl2023@learner.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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with unilateral stroke,
Individuals with functional vision,
Individuals who are able to understand and comply with basic instruction (Montreal Cognitive Assessment Score less than 26),
Individuals with Brunnstrom stage 3 or above |
|
| ExclusionCriteria |
| Details |
individuals who have undergone craniotomy or craniectomy,
those with previous impairments of upper limb and secondary complications like CRPS, shoulder subluxation grade3 or more ,
those who have resting pain with VAS more than 3, Individuals with any conditions precluding kinematic analysis such as metal implants or device implants. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Range of motion of Shoulder, elbow (angles) and trunk displacement angle from 3D analysis
Range of motion of shoulder, elbow(angles) and trunk displacement angle from 2D analysis. |
On the same day as recruitment, the assessment will be conducted once. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
Final Enrollment numbers achieved (Total)= "7"
Final Enrollment numbers achieved (India)="7" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2024 |
| Date of Study Completion (India) |
03/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study’s goal is to ascertain the concurrent validity of a 3D motion analysis with 2D video-based kinematic assessment of the upper extremities during the reach-to-grasp-to-mouth task in stroke patients utilizing measurements from G4 Polhemus electromagnetic sensors.to ascertain the inter- and intra-rater reliability of the 2D video-based kinematic assessment of stroke patients’ upper extremity reach-to-grasp-to-mouth task. Three-dimensional (3D) motion capture systems, the "gold standard" in kinematic assessment, have been employed in studies. These systems are laboratory-based. However, in order to solve some of the current drawbacks of 3D motion capture systems, including standardization, mobility, and cost and time effectiveness, researchers have also looked into alternatives. Because of the high cost and calibration challenges involved, high-end motion-capture devices—which are regarded the gold standard for kinematic assessment—are generally unattainable for researchers and clinics. In contrast, video-based systems, particularly 2D assessments, are more affordable, portable, and accessible. However, there is a limited number of studies on video-based assessments of upper limb function in stroke survivors, highlighting the need for more exploration in this area. |