Stroke, Middle Cerebral Artery With Infarction, Rehabilitation, Upper Limb Recovery, Economic BurdonNCT05894330
Perception About Upper Limb Functional Recovery, Barriers & Use of Training Devices Among Indian Stroke Survivors.
An observational study of Stroke, Middle Cerebral Artery With Infarction, Rehabilitation, Upper Limb Recovery, Economic Burdon, run by Mahatma Gandhi Institute of Medical Sciences at 1 site in India.
Trial summary
The goal of this observational study is to evaluate perceptions regarding affected arm and hand function and their willingness to use devices to enhance upper limb functions among stroke survivors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Middle Cerebral Artery With Infarction, Rehabilitation, Upper Limb Recovery, Economic Burdon
- How many people
- 196 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2021to 1 Feb 2022
- How long will I take part?
- 6 Months
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke Survivors
Who may be able to join
- First-ever stroke
- All stages of stroke
- Onset of a stroke at least 1 year ago
- Age group: 30 to 75
- Both genders included
- Patients diagnosed with MCA (Middle Cerebral Artery) stroke
Who cannot join
- Aphasia
- Patients who are unable to follow commands
- Patients with other neurological disorders such as Multiple sclerosis and Parkinson's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perception About Upper Limb Functional Recovery, Barriers & Use of Training Devices Among Stroke Survivors- A Cross-Sectional Survey
The goal of this observational study is to evaluate perceptions regarding affected arm and hand function and their willingness to use devices to enhance upper limb functions among stroke survivors. The main question[s] it aims to answer are:
- what will the stroke survivor's perception of interventions and device development in his/her arm recovery?
- Wheather he is willing to use it for his arm recovery?
Read the detailed description
Individuals with stroke will be recruited from MGM Hospital and other hospitals from Aurangabad. Participants will be adults (age >30) with stroke and with the capacity to provide written or verbal informed consent, and the ability to communicate verbally/online/phone. Participants will be contacted via phone or email by a member of the research team. If needed personal interviews of the patients will be taken. The research team will consist of the author and one helper Physical Therapy student and the guide. All team members participating in the training will ensure consistency in communications with participants. All the participants will be provided with information about the study objectives and procedures and will be asked if they are willing to participate. If they consent, they will be given one of three options:
- Complete the survey via phone immediately
- Complete the survey online. In this case, they will be sent a link to their email to complete an online survey.
- Complete the survey via personal interview
- Conditions
- Stroke, Middle Cerebral Artery With Infarction, Rehabilitation, Upper Limb Recovery, Economic Burdon
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Structured Marathi language translated Version Questionnaire
It's a 69 item questionnaire to obtain the responses from the stroke survivors about their Upper limb recovery and use of devices for the same. The Obtained responses will be used for the analyze the willingness of stroke clients for use of devices for his/her upper limb arm recovery
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Aug 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Middle Cerebral Artery With Infarction, Rehabilitation, Upper Limb Recovery, Economic BurdonStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 196 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mahatma Gandhi Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nawaj Pathan, Mahatma Gandhi Mission Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894330
- Sponsor's protocol ID
- MGM-ECRHS/2021/39
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If requested by genuine researchers or by the university officials through official email communications only.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception About Upper Limb Functional Recovery, Barriers & Use of Training Devices Among Stroke Survivors- A Cross-Sectional Survey
- ClinicalTrials.gov ID
- NCT05894330
- Acronym / sponsor ID
- MGM-ECRHS/2021/39
- Conditions
- Stroke, Middle Cerebral Artery With Infarction, Rehabilitation, Upper Limb Recovery, Economic Burdon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Mahatma Gandhi Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 8 Jun 2023 (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.
The goal of this observational study is to evaluate perceptions regarding affected arm and hand function and their willingness to use devices to enhance upper limb functions among stroke survivors. The main question[s] it aims to answer are:
- what will the stroke survivor's perception of interventions and device development in his/her arm recovery?
- Wheather he is willing to use it for his arm recovery?
Detailed description
Individuals with stroke will be recruited from MGM Hospital and other hospitals from Aurangabad. Participants will be adults (age >30) with stroke and with the capacity to provide written or verbal informed consent, and the ability to communicate verbally/online/phone. Participants will be contacted via phone or email by a member of the research team. If needed personal interviews of the patients will be taken. The research team will consist of the author and one helper Physical Therapy student and the guide. All team members participating in the training will ensure consistency in communications with participants. All the participants will be provided with information about the study objectives and procedures and will be asked if they are willing to participate. If they consent, they will be given one of three options:
- Complete the survey via phone immediately
- Complete the survey online. In this case, they will be sent a link to their email to complete an online survey.
- Complete the survey via personal interview
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke Survivors
Key inclusion criteria (6 listed)
- First-ever stroke
- All stages of stroke
- Onset of a stroke at least 1 year ago
- Age group: 30 to 75
- Both genders included
Key exclusion criteria (3 listed)
- Aphasia
- Patients who are unable to follow commands
- Patients with other neurological disorders such as Multiple sclerosis and Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self Structured Marathi language translated Version Questionnaire
Time frame: One Month
It's a 69 item questionnaire to obtain the responses from the stroke survivors about their Upper limb recovery and use of devices for the same. The Obtained responses will be used for the analyze the willingness of stroke clients for use of devices for his/her upper limb arm recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: Undecided. If requested by genuine researchers or by the university officials through official email communications only.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke, Middle Cerebral Artery With Infarction, Rehabilitation, Upper Limb Recovery, Economic Burdon, run by Mahatma Gandhi Institute of Medical Sciences 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Structured Marathi language translated Version Questionnaire (time frame: One Month). 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 8 Jun 2023.