| CTRI Number |
CTRI/2025/07/090250 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Development of Scale and Determination of its Psychometric Properties |
| Study Design |
Other |
|
Public Title of Study
|
Developing a valid and reliable novel scale to understand Human Movement using the IST Framework |
|
Scientific Title of Study
|
Development of a Movement Analysis Scale using the Initiation,
Sustenance, and Termination (IST) Framework and Determination
of its Psychometric Properties
|
| 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 Snehal Joshi PT |
| Designation |
Prinicipal and HOD Neurophysiotherapy Department |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune 411004.
Pune
MAHARASHTRA
411004
India |
| Phone |
9225340940 |
| Fax |
|
| Email |
snehal.joshi@despune.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shardul Gadre PT |
| Designation |
Post Graduate Student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune 411004.
Pune
MAHARASHTRA
411004
India |
| Phone |
8975719201 |
| Fax |
|
| Email |
shardul.gadre201@deccansociety.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shardul Gadre PT |
| Designation |
Post Graduate Student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
Neurophysiotherapy Department, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune 411004.
Pune
MAHARASHTRA
411004
India |
| Phone |
8975719201 |
| Fax |
|
| Email |
shardul.gadre201@deccansociety.org |
|
|
Source of Monetary or Material Support
|
| DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar, Pune, Maharashtra, India- 411004. |
|
|
Primary Sponsor
|
| Name |
Dr Shardul Gadre PT |
| Address |
Neurophysiotherapy Departmnet Ground Floor, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune 411004 |
| 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 Shardul Gadre PT |
Community Settings and Geriatric rehab centres |
Neurophysiotherapy Department, Ground floor, DES Brijlal Jindal College of Physiotherapy, Fergusson College Campus, Shivajinagar,Pune 411004.
Pune
MAHARASHTRA |
8975719201
shardul.gadre201@deccansociety.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC DES BJCOP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatrics (age 60 and above) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 60 years & above.
2. Able to perform the sit-to-stand movement with or without
assistance (e.g., physical assistance or use of assistive devices).
3. Able to follow commands. |
|
| ExclusionCriteria |
| Details |
1. Individuals with any recent, acute musculoskeletal
conditions (fracture or joint replacement) or neurological
condition (stroke, parkinson) that significantly affect
movement
2. Severe visual or auditory impairments that cannot be
corrected with glasses or hearing aids.
3. Refusal to provide informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Designing a clinical scale assessing movement quality |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Establishing the Content validity, Inter rater & Intra rater reliability and
Internal consistency |
8 months |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
31/07/2025 |
| 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="1"
Months="0"
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
|
Movement quality analysis plays a critical role in the assessment and treatment of individuals with motor impairments. However, most conventional assessment tools—such as the Fugl-Meyer Assessment (FMA) and the Berg Balance Scale (BBS)—primarily focus on parameters like range of motion, strength, and functional independence, often overlooking the qualitative characteristics and phase-wise structure of movement. While theoretical motor control frameworks exist, their practical clinical application remains limited, likely due to lack of structured, usable tools.
This study proposes the development and validation of a novel, clinically feasible movement analysis scale grounded in the Initiation–Sustain–Termination (IST) framework. The tool aims to help clinicians segment and evaluate movement based on distinct phases—initiation, sustenance, and termination—thus allowing for more precise identification of movement dysfunctions and facilitating targeted rehabilitation planning.
The study will be conducted in multiple phases:
-
Item generation through literature review and expert consultation
-
Face validity and revision of scale
-
Psychometric validation including content validity, internal consistency, and inter-rater reliability |