Experience of Rehabilitation Amongst Individuals With Par... | NCT05267223

Studies
Experience of Rehabilitation Amongst Individuals With Paraplegia

NCT05267223

Sponsor

Asir John Samuel

Status

Unknown status

Last Update Posted

Aug 30, 2022Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Spinal Cord Injuries

Interventions

Semi-structured interviews

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2022Actual

Primary Completion Date

Jan 1, 2023Estimated

Completion Date

Oct 1, 2023Estimated

First Submitted Date

Feb 23, 2022

First Submission Date that Met QC Criteria

Feb 23, 2022

First Posted Date

Mar 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2022

Last Update Posted Date

Aug 30, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Asir John Samuel, Professor, Maharishi Markendeswar University (Deemed to be University)Sponsor-Investigator

Lead Sponsor

Asir John SamuelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a qualitative study exploring the facilitators to physical and vocational rehabilitation and also explores the barriers in empowering individuals with paraplegia

Detailed Description

Spinal cord injury is one of the most distressing medical conditions being encountered by today's health care system. In India incidence of Spinal cord injury accounts for 20 per million per years population with 20,000 cases added every year. Rehabilitation services are of utmost importance in empowering these individuals. So there is a need for more qualitative studies through which needs in rehabilitation services can be upgraded. The aim of the study is to explore the experience of physical and vocational rehabilitation amongst the individuals with paraplegia in India

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Individuals with Paraplegia		After screening the participants according to the inclusion/exclusion criteria, informed consent will be obtained from all the selected participants. Their demographic details will be obtained and asked for their comfortable time for the interview. Data will be collected by in-depth face to face, semi- structured interviews. Audio/video recording of the interview will be taken & it will be written in English and will be transcribed verbatim also manual notes will be prepared for their analysis after the interview is conducted	Other: Semi-structured interviews

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semi-structured interviews	Other	Semi-structured interviews with individuals with paraplegia	Individuals with Paraplegia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Semi-structured interview	Semi-structured interview with audio/video recording	30minutes-45 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Traumatic & Non-Traumatic paraplegics Both male & female above 18 yrs of age Time since injury of minimum 6 months Community dwelling paraplegics

Exclusion Criteria:

Communication problems Psychiatric problems or co morbidities like head injury

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Traumatic & non-traumatic paraplegics having atleast 6 months of time since injury and are community dwelling so that their obstacles in community integration can be noted

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AKANKSHA SAXENA, MPT	Contact	7906989678		akankshasaxena623@gmail.com

Overall Officials

Name	Affiliation	Role
AKANKSHA SAXENA, MPT	MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY & REHABILITATION	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maharishi Markandeshwar institute of Medical Sciences and Research	Recruiting	Ambāla	Haryana	133207	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D010264	Paraplegia

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided