Stroke PatientsNCT06519227
Translation and Validation of Rivermead Mobility Index in Urdu
An observational study of Stroke Patients, run by Riphah International University at 1 site in Pakistan.
Trial summary
Rivermead Mobility Index (RMI) is an internationally used tool to assess mobility for both research and clinical practice in stroke survivors. This tool had previously been translated into many languages. However, the Urdu version of RMI is not available yet. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Stroke Patients
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 1 Nov 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 45 to 70 years
- All sexes
- Adult, Older adult
Study population: Whereas those with cognitive impairment, Broca aphasia Wernicke s aphasia or with other neurological disorder e.g. previous cranial traumatic injuries tumors
Who may be able to join
- patients with chronic stroke; ischemic or hemorrhagic,
- Aged between 40 to 80 years who visited the respective rehabilitation center during the study time
- Those who could read and understand Urdu.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation and Validation of Urdu Version of the Rivermead Mobility Index in Stroke Survivors
Rivermead Mobility Index (RMI) is an internationally used tool to assess mobility for both research and clinical practice in stroke survivors. This tool had previously been translated into many languages. However, the Urdu version of RMI is not available yet.
The purpose of this study was to translate the RMI into Urdu (RMI-U) and to evaluate the validity and reliability of the translated version among Urdu-speaking stroke survivors in Pakistan. A standardized stepwise forward-backward translation procedure following international guidelines, was used to translate RMI into Urdu. The RMI-U pre-final version underwent thorough psychometric testing. Content validity was evaluated by measuring content validity indices (CVIs). The test-retest reliability of final version was then evaluated among 150 stroke survivors after a one-week interval. Furthermore, internal consistency was measured by Cronbach's alpha and construct validity by exploring factor analysis using the principle of component extraction and a Varimax rotation.
Read the detailed description
Stroke is the second most common cause of death and the third most common cause of disability in adults worldwide including in Asia. Stroke survivors experience varying degrees of sensory-motor impairments including lack of mobility, reduced functional activity, and poor coordination and balance either due to muscular weakness or spasticity. Mobility is adversely affected after stroke, as patients may face many problems in moving and getting around (walking, stair climbing, etc) .
In stroke rehabilitation, it is recommended to evaluate mobility deficits using standardized tools. RMI is a valid and reliable tool, used internationally for its appropriate psychometric properties. It is used in stroke patients as a marker of mobility, which assesses balance, mobility, transfer, and gait in stroke survivors. Originally it was developed in 1991 in English language. and translated into different languages for its feasibility and responsiveness such as German, Italian, Turkish, and Brazilian, Dutch, and Danish.
Stroke is a major public health concern in developing countries of South Asia including Pakistan. The estimated incidence rate of stroke in Pakistan is 250/100,000 annually. Currently, English RMI is used for the clinical evaluation of mobility in stroke patients. Whereas Urdu is the public language of Pakistani people and most of the patients suffering from stroke belong to rural areas of Pakistan, where the literacy rate is low, and a small proportion of the population can read and understand English. Due to the language barrier and moderate pace of education, it's difficult to them to understand English language. Therefore, its Urdu translation was needed. As per knowledge of the author no Urdu version of RMI is available yet. So, this study aimed to develop Urdu version RMI-U and to test the validity and reliability of the translated version in stroke patients. So that in future it can be easily implemented throughout the Pakistani healthcare system and its utility in public and private healthcare setup could increase.
- Conditions
- Stroke Patients
- Keywords
- stroke, sub-acute stroke, translation
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Rivermead Mobility Index
mobility assessment
Measured: 2nd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start30 May 2021
- Primary completion23 Aug 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stroke PatientsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, phD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519227
- Sponsor's protocol ID
- REC/RCR&AHS/23/31
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rossier P, Wade DT. Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment. Arch Phys Med Rehabil. 2001 Jan;82(1):9-13. doi: 10.1053/apmr.2001.9396.
PubMed 11239279Franchignoni F, Tesio L, Benevolo E, Ottonello M. Psychometric properties of the Rivermead Mobility Index in Italian stroke rehabilitation inpatients. Clin Rehabil. 2003 May;17(3):273-82. doi: 10.1191/0269215503cr608oa.
PubMed 12735534Pavan K, da Cruz LC, Nunes MF, Menezes LG, Marangoni BE. Cross-cultural adaptation and validation of the Rivermead Mobility Index in stroke patients within the brazilian cultural and language context. Arq Neuropsiquiatr. 2010 Feb;68(1):52-5. doi: 10.1590/s0004-282x2010000100012.
PubMed 20339653Roorda LD, Green J, De Kluis KR, Molenaar IW, Bagley P, Smith J, Geurts AC. Excellent cross-cultural validity, intra-test reliability and construct validity of the Dutch Rivermead Mobility Index in patients after stroke undergoing rehabilitation. J Rehabil Med. 2008 Oct;40(9):727-32. doi: 10.2340/16501977-0249.
PubMed 18843424Steen Krawcyk R, Hagell P, Sjodahl Hammarlund C. Danish translation and psychometric testing of the Rivermead Mobility Index. Acta Neurol Scand. 2013 Oct;128(4):e20-5. doi: 10.1111/ane.12144. Epub 2013 Jun 13.
PubMed 23758575
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of Urdu Version of the Rivermead Mobility Index in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06519227
- Acronym / sponsor ID
- REC/RCR&AHS/23/31
- Conditions
- Stroke Patients
- Keywords
- stroke, sub-acute stroke, translation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 25 Jul 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.
Rivermead Mobility Index (RMI) is an internationally used tool to assess mobility for both research and clinical practice in stroke survivors. This tool had previously been translated into many languages. However, the Urdu version of RMI is not available yet.
The purpose of this study was to translate the RMI into Urdu (RMI-U) and to evaluate the validity and reliability of the translated version among Urdu-speaking stroke survivors in Pakistan. A standardized stepwise forward-backward translation procedure following international guidelines, was used to translate RMI into Urdu. The RMI-U pre-final version underwent thorough psychometric testing. Content validity was evaluated by measuring content validity indices (CVIs). The test-retest reliability of final version was then evaluated among 150 stroke survivors after a one-week interval. Furthermore, internal consistency was measured by Cronbach's alpha and construct validity by exploring factor analysis using the principle of component extraction and a Varimax rotation.
Detailed description
Stroke is the second most common cause of death and the third most common cause of disability in adults worldwide including in Asia. Stroke survivors experience varying degrees of sensory-motor impairments including lack of mobility, reduced functional activity, and poor coordination and balance either due to muscular weakness or spasticity. Mobility is adversely affected after stroke, as patients may face many problems in moving and getting around (walking, stair climbing, etc) .
In stroke rehabilitation, it is recommended to evaluate mobility deficits using standardized tools. RMI is a valid and reliable tool, used internationally for its appropriate psychometric properties. It is used in stroke patients as a marker of mobility, which assesses balance, mobility, transfer, and gait in stroke survivors. Originally it was developed in 1991 in English language. and translated into different languages for its feasibility and responsiveness such as German, Italian, Turkish, and Brazilian, Dutch, and Danish.
Stroke is a major public health concern in developing countries of South Asia including Pakistan. The estimated incidence rate of stroke in Pakistan is 250/100,000 annually. Currently, English RMI is used for the clinical evaluation of mobility in stroke patients. Whereas Urdu is the public language of Pakistani people and most of the patients suffering from stroke belong to rural areas of Pakistan, where the literacy rate is low, and a small proportion of the population can read and understand English. Due to the language barrier and moderate pace of education, it's difficult to them to understand English language. Therefore, its Urdu translation was needed. As per knowledge of the author no Urdu version of RMI is available yet. So, this study aimed to develop Urdu version RMI-U and to test the validity and reliability of the translated version in stroke patients. So that in future it can be easily implemented throughout the Pakistani healthcare system and its utility in public and private healthcare setup could increase.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Whereas those with cognitive impairment, Broca aphasia Wernicke s aphasia or with other neurological disorder e.g. previous cranial traumatic injuries tumors
Key inclusion criteria (3 listed)
- patients with chronic stroke; ischemic or hemorrhagic,
- Aged between 40 to 80 years who visited the respective rehabilitation center during the study time
- Those who could read and understand Urdu.
Key exclusion criteria (0 listed)
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: 2nd day
mobility assessment
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 25 Jul 2024.
- Background: PubMed 11239279Rossier P, Wade DT. Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment. Arch Phys Med Rehabil. 2001 Jan;82(1):9-13. doi: 10.1053/apmr.2001.9396.
- Background: PubMed 12735534Franchignoni F, Tesio L, Benevolo E, Ottonello M. Psychometric properties of the Rivermead Mobility Index in Italian stroke rehabilitation inpatients. Clin Rehabil. 2003 May;17(3):273-82. doi: 10.1191/0269215503cr608oa.
- Background: PubMed 20339653Pavan K, da Cruz LC, Nunes MF, Menezes LG, Marangoni BE. Cross-cultural adaptation and validation of the Rivermead Mobility Index in stroke patients within the brazilian cultural and language context. Arq Neuropsiquiatr. 2010 Feb;68(1):52-5. doi: 10.1590/s0004-282x2010000100012.
- Background: PubMed 18843424Roorda LD, Green J, De Kluis KR, Molenaar IW, Bagley P, Smith J, Geurts AC. Excellent cross-cultural validity, intra-test reliability and construct validity of the Dutch Rivermead Mobility Index in patients after stroke undergoing rehabilitation. J Rehabil Med. 2008 Oct;40(9):727-32. doi: 10.2340/16501977-0249.
- Background: PubMed 23758575Steen Krawcyk R, Hagell P, Sjodahl Hammarlund C. Danish translation and psychometric testing of the Rivermead Mobility Index. Acta Neurol Scand. 2013 Oct;128(4):e20-5. doi: 10.1111/ane.12144. Epub 2013 Jun 13.
- 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.
Binash Afzal, phD* principal investigator
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 Patients, 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 3 inclusion and 0 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 25 Jul 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: 2nd day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519227, which also lists 5 linked publications.
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 25 Jul 2024.