Abdominal SurgeriesNCT06796218
Validity and Reliability of the Arabic Version of De Morton Mobility Index After Abdominal Surgeries
An observational study of Abdominal Surgeries and Mobility Limitation, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: To determine validity and reliability of translated Arabic version of the De Morton Mobility index for mobility assessment in patients after abdominal surgeries. BACKGROUND: Major abdominal surgery has a high morbidity and Mortality rate, and the risk of surgical complications is higher than for equivalent… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Surgeries, Mobility Limitation, Mobility Difficulty
- How many people
- 103 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Jan 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will include 106 Egyptian participants of both sexes after abdominal surgeries. Their ages range between (40 and 60) years .They will be selected randomly from: • Mansoura International Hospital .
Who may be able to join
- Patients after abdominal surgeries.
- Patients aged between 40 and 60 years.
- All patients are able to read and write in Arabic language.
- All patients can understand items of the scale.
- All patients will follow the given instructions during the assessment
Who cannot join
- Patients with mental disabilities .
- Patients with communication, vision and hearing disorders
- Patients who are not co-operative .
- patients who are contraindicated to mobilize due to medical reasons.
- patients who are isolated due to infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
El-Mansoura international hospital
Al Mansurah
Basant A Younes, 01005093576, basantyounes1996@gmail.com
Karim I saafan, professor, 01110127251, dr.Karim.saafan@gmail.com
About this study
PURPOSE: To determine validity and reliability of translated Arabic version of the De Morton Mobility index for mobility assessment in patients after abdominal surgeries.
BACKGROUND:
Read more
Major abdominal surgery has a high morbidity and Mortality rate, and the risk of surgical complications is higher than for equivalent elective operations. those receiving emergency laparotomy are in a condition of physiological derangement driven by inflammation that has already occurred prior to surgery, in contrast to those undergoing elective abdominal operations. early mobility and exercise play an important role in postoperative treatment following abdominal surgery and are related with reduced postoperative fitness loss and fewer postoperative complications in individuals undergoing elective surgery. reduced mobility is a primary factor of lower quality of life and decreased social participation. reduced mobility is particularly common in older hospitalized patients, and it leads to an increased risk of falls, longer hospitalizations, more severe impairment and morbidity, and higher mortality rates. To manage elderly patients' mobility function, a reliable and valid mobility assessment tool is required. Performance-based examinations are commonly used to measure the mobility of elderly individuals. The De Morton Mobility Index (DEMMI) was established and validated exclusively for older patients hospitalized in the ward. The DEMMI provides clinicians and researchers with a valid interval-level method for accurately measuring and monitoring mobility levels of acute medical patients. It has been validated also in sub acute hospital and community settings. A DEMMI score of <40 indicates an independent risk of serious postoperative complications. A low DEMMI score suggested impaired mobilization, and prior research of patients following abdominal surgery discovered that delayed mobilization was related with postoperative pulmonary complications.
HYPOTHESES: It will be hypothesized that: Arabic version of the De Morton Mobility Index may be valid and reliable in patients after abdominal surgeries.
RESEARCH QUESTION: Is The Arabic version of the De Morton Mobility index valid and reliable for mobility assessment in patients after abdominal surgeries?
Read the detailed description
This study will be designed to assess the validity and reliability of the Arabic version of De Morton mobility index in patients after abdominal surgeries.
Study Design: This study is designed as a cross-sectional study. Subjects: The study will include 106 Egyptian participants of both sexes after abdominal surgeries. Their ages range between (40 and 60) years .They will be selected randomly from: Mansoura International Hospital .
Material: Data will be collected mainly from Mansoura Hospitals through the use of The Arabic version of De Morton Mobility Index.
study scale and its scoring: The De Morton Mobility Index (DEMMI) is a 15-item clinician-rated performance-based measure of mobility in older adults. The DEMMI has minimal equipment requirements and the scale protocol and scoring system fit onto one page. Only a bed or plinth, armchair (seat height 45 cm) and pen are required to conduct the test.
The 15 tasks will be given in order of difficulty, beginning with bed (3 items), then chair (3 items), static balance (4 items), walking (2 items), and dynamic balance (3 items). The overall score runs from 0 to 100, with 0 representing severely limited physical mobility and 100 indicating independent mobility. Any competent healthcare provider can administer the DEMMI with minimum equipment.
Methods: This study will follow the guidelines of Sousa in translation. Step 1: Forward translation (Initial translation) Step 2: Synthesis of translation Step 3: Backward translation Step 4: Expert review Step 5: Test of pre-final testing Step 6: Authentication Psychometric properties: The final Arabic version of DE Morton Mobility Index will be assessed with regard to the validity and reliability using psychometric tests.
The scores will be administered twice to ensure test/retest reliability. The first score was obtained immediately following the procedure, and the second one week later.
- Keywords
- mobility limitation, mobility difficulty, abdominal surgeries, abdominal surgical approaches
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The study will include106 Egyptian participants of both sexes after abdominal surgeries | The study will include 103 Egyptian participants of both sexes after abdominal surgeries. Their ages range between (60 and 90) years. Inclusion criteria: 1. Patients after abdominal surgeries. 2. Patients aged between 40 and 60 years. 3. All patients are able to read and write in Arabic language. 4. All patients can understand items of the scale. 5. All patients will follow the given instructions during the assessment. Exclusion criteria: 1. Patients with mental disabilities . 2. Patients with communication, vision and hearing disorders 3. Patients who are not co-operative . 4. patients who are contraindicated to mobilize due to medical reasons. 5. patients who are isolated due to infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity of de morton mobility index
De morton mobility index is a scale for mobility assessment. it's score ranges from 0 (the minimum) to 19 the maximum(which is the best ). Clarity index and expert proportion of the clearance were used to test( face validity).
Index of content validity (CVI), scale content validity indices (S-CVI) and expert proportion of relevance were used to test the (content validity).
Measured: 3 months from September,2024 to December, 2024
reliability of De morton mobility index
Cronbach's alpha will be used to measure the internal consistency reliability. Test-retest reliability will be measured using intraclass correlation coefficient (ICC). The level of significance for all statistical tests will be set at p < 0.05. the study includes 103 participants the lowest score (minimum )for this scale is 0 (worse outcome) the highest score (maximum) for this scale is 19 (interpreted as better outcome) the conversion table's scores ranged from (0 to 100) DEMMI is the abbreviation of De Morton Mobility Index.
Measured: 3 months from September, 2024 to December, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Sep 2024
- Primary completion30 Dec 2024
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeriesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basant Ashraf Younes Mohamed, Cairo University
- Investigators
- Eman M Othman, professor, Study chair, faculty of physical therapy, department of surgery, cairo university.Karim I Saafan, Professor, Study chair, faculty of physical therapy, department of surgery, cairo university.Amr A Abouzid, professor, Study chair, Faculty of Medicine, Mansoura UniversityBasant A younes, B.Sc.of PT, Principal investigator, B.Sc., Faculty of Physical Therapy, Department of PT for Surgery, Delta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796218
- Sponsor's protocol ID
- DE Morton index after surgries
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Arabic Version of De Morton Mobility Index After Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06796218
- Acronym / sponsor ID
- DE Morton index after surgries
- Keywords
- mobility limitation, mobility difficulty, abdominal surgeries, abdominal surgical approaches
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
PURPOSE: To determine validity and reliability of translated Arabic version of the De Morton Mobility index for mobility assessment in patients after abdominal surgeries.
BACKGROUND:
Major abdominal surgery has a high morbidity and Mortality rate, and the risk of surgical complications is higher than for equivalent elective operations. those receiving emergency laparotomy are in a condition of physiological derangement driven by inflammation that has already occurred prior to surgery, in contrast to those undergoing elective abdominal operations. early mobility and exercise play an important role in postoperative treatment following abdominal surgery and are related with reduced postoperative fitness loss and fewer postoperative complications in individuals undergoing elective surgery. reduced mobility is a primary factor of lower quality of life and decreased social participation. reduced mobility is particularly common in older hospitalized patients, and it leads to an increased risk of falls, longer hospitalizations, more severe impairment and morbidity, and higher mortality rates. To manage elderly patients' mobility function, a reliable and valid mobility assessment tool is required. Performance-based examinations are commonly used to measure the mobility of elderly individuals. The De Morton Mobility Index (DEMMI) was established and validated exclusively for older patients hospitalized in the ward. The DEMMI provides clinicians and researchers with a valid interval-level method for accurately measuring and monitoring mobility levels of acute medical patients. It has been validated also in sub acute hospital and community settings. A DEMMI score of <40 indicates an independent risk of serious postoperative complications. A low DEMMI score suggested impaired mobilization, and prior research of patients following abdominal surgery discovered that delayed mobilization was related with postoperative pulmonary complications.
HYPOTHESES: It will be hypothesized that: Arabic version of the De Morton Mobility Index may be valid and reliable in patients after abdominal surgeries.
RESEARCH QUESTION: Is The Arabic version of the De Morton Mobility index valid and reliable for mobility assessment in patients after abdominal surgeries?
Detailed description
This study will be designed to assess the validity and reliability of the Arabic version of De Morton mobility index in patients after abdominal surgeries.
Study Design: This study is designed as a cross-sectional study. Subjects: The study will include 106 Egyptian participants of both sexes after abdominal surgeries. Their ages range between (40 and 60) years .They will be selected randomly from: Mansoura International Hospital .
Material: Data will be collected mainly from Mansoura Hospitals through the use of The Arabic version of De Morton Mobility Index.
study scale and its scoring: The De Morton Mobility Index (DEMMI) is a 15-item clinician-rated performance-based measure of mobility in older adults. The DEMMI has minimal equipment requirements and the scale protocol and scoring system fit onto one page. Only a bed or plinth, armchair (seat height 45 cm) and pen are required to conduct the test.
The 15 tasks will be given in order of difficulty, beginning with bed (3 items), then chair (3 items), static balance (4 items), walking (2 items), and dynamic balance (3 items). The overall score runs from 0 to 100, with 0 representing severely limited physical mobility and 100 indicating independent mobility. Any competent healthcare provider can administer the DEMMI with minimum equipment.
Methods: This study will follow the guidelines of Sousa in translation. Step 1: Forward translation (Initial translation) Step 2: Synthesis of translation Step 3: Backward translation Step 4: Expert review Step 5: Test of pre-final testing Step 6: Authentication Psychometric properties: The final Arabic version of DE Morton Mobility Index will be assessed with regard to the validity and reliability using psychometric tests.
The scores will be administered twice to ensure test/retest reliability. The first score was obtained immediately following the procedure, and the second one week later.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study will include106 Egyptian participants of both sexes after abdominal surgeries | – | –The study will include 103 Egyptian participants of both sexes after abdominal surgeries. Their ages range between (60 and 90) years. Inclusion criteria: 1. Patients after abdominal surgeries. 2. Patients aged between 40 and 60 years. 3. All patients are able to read and write in Arabic language. 4. All patients can understand items of the scale. 5. All patients will follow the given instructions during the assessment. Exclusion criteria: 1. Patients with mental disabilities . 2. Patients with communication, vision and hearing disorders 3. Patients who are not co-operative . 4. patients who are contraindicated to mobilize due to medical reasons. 5. patients who are isolated due to infection. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include 106 Egyptian participants of both sexes after abdominal surgeries. Their ages range between (40 and 60) years .They will be selected randomly from: • Mansoura International Hospital .
Key inclusion criteria (5 listed)
- Patients after abdominal surgeries.
- Patients aged between 40 and 60 years.
- All patients are able to read and write in Arabic language.
- All patients can understand items of the scale.
- All patients will follow the given instructions during the assessment
Key exclusion criteria (5 listed)
- Patients with mental disabilities .
- Patients with communication, vision and hearing disorders
- Patients who are not co-operative .
- patients who are contraindicated to mobilize due to medical reasons.
- patients who are isolated due to infection.
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
validity of de morton mobility index
Time frame: 3 months from September,2024 to December, 2024
De morton mobility index is a scale for mobility assessment. it's score ranges from 0 (the minimum) to 19 the maximum(which is the best ). Clarity index and expert proportion of the clearance were used to test( face validity). Index of content validity (CVI), scale content validity indices (S-CVI) and expert proportion of relevance were used to test the (content validity).
reliability of De morton mobility index
Time frame: 3 months from September, 2024 to December, 2024
Cronbach's alpha will be used to measure the internal consistency reliability. Test-retest reliability will be measured using intraclass correlation coefficient (ICC). The level of significance for all statistical tests will be set at p < 0.05. the study includes 103 participants the lowest score (minimum )for this scale is 0 (worse outcome) the highest score (maximum) for this scale is 19 (interpreted as better outcome) the conversion table's scores ranged from (0 to 100) DEMMI is the abbreviation of De Morton Mobility Index.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- De Morton, N. A., Davidson, M., \& Keating, J. L. (2008). The de Morton Mobility Index (DEMMI): An essential health index for an ageing world. Health and Quality of Life Outcomes, 6Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Eman M Othman, professor study chair
faculty of physical therapy, department of surgery, cairo university.
Karim I Saafan, Professor study chair
faculty of physical therapy, department of surgery, cairo university.
Amr A Abouzid, professor study chair
Faculty of Medicine, Mansoura 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 Abdominal Surgeries and Mobility Limitation, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Basant A younes (01005093576, basantyounes1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity of de morton mobility index (time frame: 3 months from September,2024 to December, 2024). The study lists 2 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 28 Jan 2025.