| CTRI Number |
CTRI/2024/05/067628 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring physical risks experienced by People with Mobility Disabilities while driving a modified scooter. |
|
Scientific Title of Study
|
Investigation of biomechanical risks encountered by persons with mobility disabilities driving a modified commercial scooter. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishbha Tiku |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy
MCHP
MAHE
Madhav Nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9663982342 |
| Fax |
|
| Email |
rishbha.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sidhiprada Mohapatra |
| Designation |
Assistant Professor Selection Grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy
MCHP
MAHE
Madhav Nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7008179030 |
| Fax |
|
| Email |
sidhi.mohapatra@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Navada GV |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy
MCHP
MAHE
Madhav Nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886430431 |
| Fax |
|
| Email |
rajesh.gv@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy
Manipal College of Health Professions
Madhav Nagar
Manipal
Karnataka 576104
|
|
|
Primary Sponsor
|
| Name |
Rishbha Tiku |
| Address |
Department of Physiotherapy
Madhav Nagar
Manipal
Karnataka 576104 |
| Type of Sponsor |
Other [Self-sponsored] |
|
|
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 |
| Rishbha Tiku |
Manipal College of Health Professions, Manipal Academy of Higher Educations |
Room No. 215, 2nd floor, Tower II, Department of Physiotherapy, Manipal 576104
Udupi
KARNATAKA |
9663982342
rishbha.mchpmpl2023@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| 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 |
| Healthy Human Volunteers |
Healthy volunteers without these conditions will be screened as controls for evaluation of biomechanical risks. |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Persons with mobility disabilities who are self ambulatory with or without assistive device.
A person with benchmark disability (holding UDID card)
Persons holding valid driving license for use of mobility scooter
Persons above 18 years of age.
Any sex
Experience of mobility scooter ≥ 6 months for community ambulation. |
|
| ExclusionCriteria |
| Details |
Intellectual disabilities
Mental Illness
Multiple disabilities, including Visual and Hearing impairments |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the musculoskeletal complaints encountered by persons with mobility disability using a modified commercial scooter. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To investigate biomechanical risks encountered by persons with mobility disability riding a modified commercial scooter using a 2D Kinematic analysis through videography. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
20/06/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Biomechanical risks have been identified among riders and users of wheeled devices like wheelchair and mobility scooter. Studies have shown that individuals without disabilities, driving scooters experience biomechanical risks contributing to musculoskeletal complaints. However, there appears to be no research conducted on commercial scooters and the biomechanical risks experienced by drivers with mobility impairments. The study will include administering a questionnaire pertaining to the risk factors that can be encountered while riding a modified commercial scooter for persons with mobility disability . The study will be conducted in 2 phases. Phase 1 will include administering the prepared questionnaire to the inclusion population and Phase 2 will include conducting a pilot study on persons with and without mobility disability.The participants for the healthy control group will be age and gender matched. Video recording of the participants will be done for posture analysis.
This study is an observational study where the participants will be using their own scooters that they use for their daily mobility. This is their Standard Mode of transportation. The investigators will not intervene or compare between different scooters. |