StrokeNCT06406036
A Validity and Reliability Study for Urdu Version of Rivermead Mobility Index in Stroke Patients
An observational study of Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the study is to translate and cross-culturally adapt the Rivermead mobility index questionnaire into traditional Urdu language to investigate its psychometric properties (reliability \& validity) for those patients who are confronting stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 20 Jul 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: Target population for this study will be diagnosed cases of stroke.
Who may be able to join
- Male and female both genders
- Adults between the ages of 18 and above
- Stroke patients ( chronic)
- Ability to provide informed consent
Who cannot join
- Any musculoskeletal pathologies
- Suffering from any cardiovascular pathologies
- Any history of fracture
- Any histories of infections
- Any history of neurological disorders
- Having any spinal deformity
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Reliability and Validity of Rivermead Mobility Index in Urdu Language Among Pakistani Stroke Population
The aim of the study is to translate and cross-culturally adapt the Rivermead mobility index questionnaire into traditional Urdu language to investigate its psychometric properties (reliability \& validity) for those patients who are confronting stroke.
Read the detailed description
As per preceding commendation, Rivermead Mobility Index will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among Stroke population, Rivermead Mobility Index will be conducted in 50 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Rivermead Mobility Index, Barthel Index and Functional Independence Measure will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 has been used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Rivermead Mobility Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.
- Conditions
- Stroke
- Keywords
- Rivermead Mobility Index, Urdu Version, Reliability, Validity, Stroke, Mobility
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Rivermead Mobility Index
The Rivermead Mobility index is a standardized assessment tool to investigate patients work and activity specific physical disability related to work. Rivermead Mobility Index scale have 15 items.
Measured: 1st day
Barthel Index
The Barthel Index is an ordinal scale that is used to assess performance in daily activities. A higher number reflects better capacity to operate independently upon hospital release.
Measured: 1st day
Functional Independence Measure
Functional Independence Measure instrument was designed for assessing responsive changes throughout the course of a complete inpatient medical rehabilitation programme. The instrument is used to determine a patient's level of impairment as well as any changes in their condition as a result of rehabilitation or medical treatment. Is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start30 May 2021
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406036
- Sponsor's protocol ID
- REC/FSD/0293
- Status last verified
- May 2024
- First submitted
- 27 Jun 2022
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Rivermead Mobility Index in Urdu Language Among Pakistani Stroke Population
- ClinicalTrials.gov ID
- NCT06406036
- Acronym / sponsor ID
- REC/FSD/0293
- Conditions
- Stroke
- Keywords
- Rivermead Mobility Index, Urdu Version, Reliability, Validity, Stroke, Mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 9 May 2024 (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 aim of the study is to translate and cross-culturally adapt the Rivermead mobility index questionnaire into traditional Urdu language to investigate its psychometric properties (reliability \& validity) for those patients who are confronting stroke.
Detailed description
As per preceding commendation, Rivermead Mobility Index will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among Stroke population, Rivermead Mobility Index will be conducted in 50 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Rivermead Mobility Index, Barthel Index and Functional Independence Measure will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 has been used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Rivermead Mobility Index will be evaluated for content validity, construct validity, criterion validity and responsiveness.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target population for this study will be diagnosed cases of stroke.
Key inclusion criteria (4 listed)
- Male and female both genders
- Adults between the ages of 18 and above
- Stroke patients ( chronic)
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Any musculoskeletal pathologies
- Suffering from any cardiovascular pathologies
- Any history of fracture
- Any histories of infections
- Any history of neurological disorders
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
Rivermead Mobility Index
Time frame: 1st day
The Rivermead Mobility index is a standardized assessment tool to investigate patients work and activity specific physical disability related to work. Rivermead Mobility Index scale have 15 items.
Barthel Index
Time frame: 1st day
The Barthel Index is an ordinal scale that is used to assess performance in daily activities. A higher number reflects better capacity to operate independently upon hospital release.
Functional Independence Measure
Time frame: 1st day
Functional Independence Measure instrument was designed for assessing responsive changes throughout the course of a complete inpatient medical rehabilitation programme. The instrument is used to determine a patient's level of impairment as well as any changes in their condition as a result of rehabilitation or medical treatment. Is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.
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 9 May 2024.
- 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.
Muhammad Kashif study chair
Riphah International University
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, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 6 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 9 May 2024. 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 Pakistan. 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?
Rivermead Mobility Index (time frame: 1st day). The study lists 3 primary outcomes in all. 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 9 May 2024; AzTrials last refreshed its copy on 2 Nov 2026.