Spinal Cord InjuriesNCT05267223
Experience of Rehabilitation Amongst Individuals With Paraplegia
An observational study of Spinal Cord Injuries, run by Asir John Samuel at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Semi-structured interviews
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- 2 May 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- Traumatic \& Non-Traumatic paraplegics Both male \& female above 18 yrs of age Time since injury of minimum 6 months Community dwelling paraplegics
Who cannot join
- Communication problems Psychiatric problems or co morbidities like head injury
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Maharishi Markandeshwar institute of Medical Sciences and Research
Ambāla, Haryana, 133207
AKANKSHA SAXENA, MPT, 7906989678, akankshasaxena623@gmail.com
Asir J Samuel, PhD, 8059930222, asirjohnsamuel@mmumullana.org
About this study
Official title: Experience of Physical and Vocational Rehabilitation Amongst Individuals With Paraplegia
This study is a qualitative study exploring the facilitators to physical and vocational rehabilitation and also explores the barriers in empowering individuals with paraplegia
Read the 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
- Conditions
- Spinal Cord Injuries
- Being tested
- Semi-structured interviews
- Keywords
- qualitative research, paraplegia, rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
Semi-structured interviews with individuals with paraplegia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interview
Semi-structured interview with audio/video recording
Measured: 30minutes-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start2 May 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- AKANKSHA SAXENA, MPT, Principal investigator, MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY & REHABILITATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267223
- Sponsor's protocol ID
- MMDU/IEC/2154
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Physical and Vocational Rehabilitation Amongst Individuals With Paraplegia
- ClinicalTrials.gov ID
- NCT05267223
- Acronym / sponsor ID
- MMDU/IEC/2154
- Conditions
- Spinal Cord Injuries
- Keywords
- qualitative research, paraplegia, rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Paraplegia | – | Other: Semi-structured interviewsAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- Traumatic \& Non-Traumatic paraplegics Both male \& female above 18 yrs of age Time since injury of minimum 6 months Community dwelling paraplegics
Key exclusion criteria (1 listed)
- Communication problems Psychiatric problems or co morbidities like head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewsSemi-structured interviews with individuals with paraplegia | Other | Individuals with Paraplegia |
Primary outcome
Semi-structured interview
Time frame: 30minutes-45 minutes
Semi-structured interview with audio/video recording
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AKANKSHA SAXENA, MPT principal investigator
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY & REHABILITATION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AKANKSHA SAXENA, MPT (7906989678, akankshasaxena623@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured interview (time frame: 30minutes-45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.