| CTRI Number |
CTRI/2024/10/074803 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Designing and Developing a Multipurpose Assistive device for walking |
|
Scientific Title of Study
|
Designing and Developing a Multipurpose Mobility Aid A Multiphasic Exploratory Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dabhi Mehul Naranbhai |
| Designation |
Post Graduate student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
9737111866 |
| Fax |
|
| Email |
mdabhi692@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sojitra |
| Designation |
Assistant Professor, School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK University. |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
7984098112 |
| Fax |
|
| Email |
namrata.sojitra@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dabhi Mehul Naranbhai |
| Designation |
Post Graduate student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
9737111866 |
| Fax |
|
| Email |
mdabhi692@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Dabhi Mehul Naranbhai, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar highway, Rajkot, Gujarat, India 360020 |
|
|
Primary Sponsor
|
| Name |
Dabhi Mehul Naranbhai |
| Address |
School of Physiotherapy , RK University, Kasturbadham ,
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India |
| 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 Mehul Dabhi |
RK Physiotherapy Rehabilitation and Research center |
Physiotherapy
Department, Room no.
1, opp Meghani rang
bhuvan,Bhaktinagar
circle Rajkot, Gujarat,
India
Rajkot
GUJARAT |
9737111866
mdabhi692@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multipurpose mobility aid |
This device is used as an assistance device for walking. Training will be given for 1 day and feedback will be taken |
| Comparator Agent |
Traditional walker, cane |
This device is currently used as assistance device for walking. Training will be given for 1 day and feedback will be taken. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals requiring mobility aid assistance
Both male and female
|
|
| ExclusionCriteria |
| Details |
Non consent individual
Cognitive impairment |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quest 2 |
Post outcome after intervention of 1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time up and go test |
Post outcome after intervention of 1 day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="3"
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
|
Title: Designing and developing a multipurpose mobility aid: A multiphasic exploratory study.
Investigator: Mehul Dabhi; PT, Dr. Namrata Sojitra; MPT, PhD Scholar, School of Physiotherapy, RK University.
Background: WHO projects global elderly population (60+) to double by 2050, reaching 2.1 billion. India’s elderly population expected to rise from 104 million in 2011 to 340 million by 2050 (MoSPI, 2016). Which leads to increase in prevalence of mobility-limiting conditions like osteoarthritis, stroke, and fractures. Also Surge in total knee (TKR) and hip replacements (THR) to manage these conditions effectively. TKR surgeries increased from 1,019 in 2006 to 27,000 in 2019, predominantly for osteoarthritis. Approximately 4,700 hip implant surgeries conducted with DePuy’s ASR system by May 2019. 2.3% of India’s population require mobility aids due to disabilities. Walkers, canes are crucial in physiotherapy for orthopaedic and neurological conditions, enhancing mobility and independence. The current landscape of mobility aids presents significant challenges for patients with mobility impairments, who often need multiple devices, leading to increased costs and complexity. This issue is particularly critical in India, where the elderly population is growing and facing higher incidences of conditions like osteoarthritis and lower limb fractures. Traditional mobility aids often fail to provide the necessary convenience and flexibility, which can result in reduced patient satisfaction and slower rehabilitation progress. Therefore, there is an urgent need for cost-effective, multipurpose mobility aid that can enhance usability, reduce expenses, and improve rehabilitation outcomes, ultimately improving the quality of life for elderly patients and those recovering from lower limb impairments.
Method: Following ethical approval, 60 subjects will be selected as per inclusion and exclusion criteria. Group 1 will receive walking training with traditional walker and Group 2 will receive walking training with multipurpose mobility aid. The outcome measures will be assessed after the intervention.
This study is divided into 3 phase: Phase 1- Designing multipurpose mobility aid. Phase 2- Development of multipurpose mobility aid. Phase 3- Testing effectiveness of multipurpose mobility aid.
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