| CTRI Number |
CTRI/2025/11/097663 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How walking aids help improve quality of life for people with lower limb disability |
|
Scientific Title of Study
|
Evaluation of the psychosocial impact of assistive devices among persons with lower limb locomotor disability: -A
Descriptive cross-sectional 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 |
Dr Mohammed Faiz O |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
4th floor ,B wing All India Institute of Physical Medicine and Rehabilitation ,Haji Ali,K Khadye Marg,Mahalaxmi,Mumbai
Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
6282561083 |
| Fax |
|
| Email |
Otakathfaiz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Goyal |
| Designation |
Professor |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Physical Medicine and Rehabilitation ,Haji Ali, K Khadye Marg, Mahalaxmi, Mumbai
Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
7045773329 |
| Fax |
|
| Email |
vinaygoyal80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay Goyal |
| Designation |
Professor |
| Affiliation |
All India Institute of Physical Medicine and Rehabilitation |
| Address |
Department of Physical Medicine and Rehabilitation, All India Institute of Physical Medicine and Rehabilitation ,Haji Ali, K Khadye Marg, Mahalaxmi, Mumbai
Mumbai
Mumbai
MAHARASHTRA
400034
India |
| Phone |
7045773329 |
| Fax |
|
| Email |
vinaygoyal80@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Physical Medicine and Rehabilitation
KK Marg,Haji Ali ,Mahalaxmi ,Mumbai 400034 |
|
|
Primary Sponsor
|
| Name |
Dr Mohammed Faiz O |
| Address |
4th floor ,B wing All India Institute of Physical Medicine and Rehabilitation ,Haji Ali,K Khadye Marg, Mahalaxmi, Mumbai
, Maharashtra ,India -400034 |
| 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 Mohammed Faiz O |
All India Institute of Physical Medicine and Rehabilitation |
Department of Physical Medicine and Rehabilitation Haji Ali ,K Khadye Marg ,Mahalaxmi, Mumbai
Maharashtra ,India,-400034
Mumbai
MAHARASHTRA |
6282561083
Otakathfaiz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G80-G83||Cerebral palsy and other paralytic syndromes, (2) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Age 18–70 years
• Person with LMN or UMN lesion with lower limb involvement
• Individuals with lower limb locomotor disability using an assistive device (lower limb orthosis and or ambulatory aid) for 6 months
• Willingness to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
•Individuals with cognitive impairments unable to respond to questionnaires |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Psychosocial Impact of Assistive Devices Scale (PIADS) |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study aims to assess the psychosocial impact of assistive devices on eligible patients (aged 18-70) with lower limb locomotor disability, a topic underexplored, particularly in the Indian context. Patients using a device for at least six months will be recruited, and data will be collected on their demographics, clinical details, and device type. The Psychosocial Impact of Assistive Devices Scale (PIADS) will be administered, rating the impact from –3 (maximum negative) to +3 (maximum positive) across 26 items, which will be used to calculate subscale scores for Competence, Adaptability, and Self-esteem, as well as a total mean PIADS score. While assistive devices are known for their physical benefits, this research recognizes that psychosocial factors—such as issues with self-esteem, confidence, stigmatization, or device malfunction—significantly influence adoption and continued use; therefore, understanding these effects is essential to optimize device use, guide prescription, and ultimately improve the users’ quality of life and inform healthcare professionals and policy-makers.
|