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This study argues that providing evidence-based occupational therapy patient education is vital in order to optimize rehabilitation outcomes. The planned trial aims to evaluate the SADL-eM intervention for people with SCI compared with standard treatment.
This is a parallel randomized clinical trial with two study arms, intervention and control. Ninety patients treated in three inpatient rehabilitation settings will be randomly allocated to two study groups. Both groups will receive standard care. The intervention group will also receive a copy of the SADL-eM from their treating occupational therapist during an individual session. Assessment on admission (baseline measure) and after six weeks of admission will use the SCIM-SR as the primary outcome measure. Secondary outcomes include the SCIM-III, Private Religiousness Practices Scale, Organizational Religiousness Short-Form, additional domains of ADL covered by the educational manual, and adherence to the intervention. The effect will be determined using repeated-measures ANOVA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SADL-eM & conventional therapy | Experimental | Patients with SCI treated in an inpatient rehabilitation setting who receive a copy of the SADL-eM in addition to conventional therapy. |
|
| Conventional therapy | No Intervention | Patients with SCI treated in an inpatient rehabilitation setting who receive conventional therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SADL-eM | Other | The SADL-eM includes three elements essential to the intervention, namely: knowledge, skills, and advice. The manual includes 92 A5 pages with six detailed sections: an Introduction and five chapters: (1) Rehabilitation team, (2) Activities of Daily Living, (3) Assistive devices, (4) Home environment adaptation, and (5) Knowledge guide. The SADL-eM uses text and illustrative pictures that are carefully selected for contextual relevance. The manual is simple, easy, and suitable for people with a non-medical background. |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment | Spinal Cord Independence Measure-Self Reported is a patient-reported 17-item tool that evaluates the ability of a person with SCI to perform specified activities independently, with assistance, or with assistive devices. Total score ranges between 0-100, higher scores mean better. | within 3 days of admission |
| Spinal Cord Independence Measure-Self Reported (SCIM-SR) change after six weeks | Spinal Cord Independence Measure-Self Reported is a patient-reported 17-item tool that evaluates the ability of a person with SCI to perform specified activities independently, with assistance, or with assistive devices. Total score ranges between 0-100, higher scores mean better. | Six weeks after admission |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Cord Independence Measure-III (SCIM-III) baseline assessment | Spinal Cord Independence Measure-III is a 17-task tool that evaluates the ability of a person with SCI to perform specified activities independently, with assistance, or with assistive devices. It is therapist-reported. Total score ranges between 0-100, higher scores mean better. | within 3 days of admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moussa Abu Mostafa, Master | Contact | 0597401091 | moussaabumostafa@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Moussa Abu Mostafa, Master | Hamad Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Rehabilitation Hospital | Gaza | Gaza Strip | 1051 | Palestinian Territories |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30616508 | Background | Magill N, Knight R, McCrone P, Ismail K, Landau S. A scoping review of the problems and solutions associated with contamination in trials of complex interventions in mental health. BMC Med Res Methodol. 2019 Jan 7;19(1):4. doi: 10.1186/s12874-018-0646-z. | |
| 29403314 | Background | Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018. |
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There is no plan to make IPD available. Data collected will be used only for analysis and results production.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2021 | Jan 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Randomized clinical trial
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The research assistant who will perform data collection will be blinded to the patient group.
|
|
| Spinal Cord Independence Measure-III (SCIM-III) change after six weeks | Spinal Cord Independence Measure-III is a 17-task tool that evaluates the ability of a person with SCI to perform specified activities independently, with assistance, or with assistive devices. It is therapist-reported. Total score ranges between 0-100, higher scores mean better. | Six weeks after admission |
| ElAmal Rehabilitation Hospital | Khan Yunis | Gaza Strip | Palestinian Territories |
|
| ElWafa Rehabilitation Hospital | Zahra City | Gaza Strip | 1051 | Palestinian Territories |
|
| Background | Bodling, A., Heneghan, M., Walsh, J. C., Yoon, D. P., & Johnstone, B. (2013). The brief multidimensional measure of religiousness/spirituality with an irish sample: A factor analysis. International Journal of Therapy and Rehabilitation, 20(2), 72-78. https://doi.org/10.12968/ijtr.2013.20.2.72 |
| 30487829 | Background | De Las Cuevas C, Penate W. Psychometric properties of the eight-item Morisky Medication Adherence Scale (MMAS-8) in a psychiatric outpatient setting. Int J Clin Health Psychol. 2015 May-Aug;15(2):121-129. doi: 10.1016/j.ijchp.2014.11.003. Epub 2014 Dec 25. |
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| 17695343 | Background | Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. |
| 22890418 | Background | Fekete C, Eriks-Hoogland I, Baumberger M, Catz A, Itzkovich M, Luthi H, Post MW, von Elm E, Wyss A, Brinkhof MW. Development and validation of a self-report version of the Spinal Cord Independence Measure (SCIM III). Spinal Cord. 2013 Jan;51(1):40-7. doi: 10.1038/sc.2012.87. Epub 2012 Aug 14. |
| 15388912 | Background | Krueger C, Tian L. A comparison of the general linear mixed model and repeated measures ANOVA using a dataset with multiple missing data points. Biol Res Nurs. 2004 Oct;6(2):151-7. doi: 10.1177/1099800404267682. |
| Background | Fetzer Institute, N. I. on A. W. G. (2003). Multidimensional Measurement of Religiousness/ Spirituality for Use in Health Research: A Report of the Fetzer Institute/ National Institute on Aging Working Group. |
| 19774305 | Background | Glass CA, Tesio L, Itzkovich M, Soni BM, Silva P, Mecci M, Chadwick R, el Masry W, Osman A, Savic G, Gardner B, Bergstrom E, Catz A. Spinal Cord Independence Measure, version III: applicability to the UK spinal cord injured population. J Rehabil Med. 2009 Sep;41(9):723-8. doi: 10.2340/16501977-0398. |
| 28895576 | Background | Itzkovich M, Shefler H, Front L, Gur-Pollack R, Elkayam K, Bluvshtein V, Gelernter I, Catz A. SCIM III (Spinal Cord Independence Measure version III): reliability of assessment by interview and comparison with assessment by observation. Spinal Cord. 2018 Jan;56(1):46-51. doi: 10.1038/sc.2017.97. Epub 2017 Sep 12. |
| 20332511 | Background | Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available. |
| Background | Mostafa, M. A., Plastow, A. N., and Savin-Baden, M. (2019). The effectiveness of spinal cord injury ADL inpatient education on rehabilitation outcomes: A systematic review and meta-analysis. British Journal of Occupational Therapy, 83,(1), 15-28. DOI: 10.1177/0308022619879019 |
| Background | Mostafa, M. A., Plastow, A. N., and Savin-Baden, M. (2020). Developing of an Evidence-Informed Activities of Daily Living Educational Manual. Manuscript submitted for publication |
| Background | Polit, D. F., Beck, C. T. and Hungler, B. P. (2001). Essentials of Nursing Research: Methods, Appraisals, and Utilization. Fifth edition.: Lippincott, USA. |
| Background | Quittner, A. L., Espelage, D. L., Ievers-Landis, C., & Drotar, D. (2000). Measuring adherence to medical treatments in childhood chronic illness: Considering multiple methods and sources of information. Journal of Clinical Psychology in Medical Settings, 7(1), 41-54. https://doi.org/10.1023/A:1009545319673 |
| 32858735 | Background | Wasson JH. Practice Standards for Effective Telemedicine in Chronic Care Management After COVID-19. J Ambul Care Manage. 2020 Oct/Dec;43(4):323-325. doi: 10.1097/JAC.0000000000000355. No abstract available. |
| 18581660 | Result | Anderson K, Aito S, Atkins M, Biering-Sorensen F, Charlifue S, Curt A, Ditunno J, Glass C, Marino R, Marshall R, Mulcahey MJ, Post M, Savic G, Scivoletto G, Catz A; Functional Recovery Outcome Measures Work Group. Functional recovery measures for spinal cord injury: an evidence-based review for clinical practice and research. J Spinal Cord Med. 2008;31(2):133-44. doi: 10.1080/10790268.2008.11760704. |
| 21191081 | Result | Chou HK, Lin IC, Woung LC, Tsai MT. An empirical study on outpatients' health education needs and the effectiveness of e-learning. Health Promot Pract. 2012 Jan;13(1):133-9. doi: 10.1177/1524839910385896. Epub 2010 Dec 29. |
| 21574732 | Result | Letts L, Martin Ginis KA, Faulkner G, Colquhoun H, Levac D, Gorczynski P. Preferred methods and messengers for delivering physical activity information to people with spinal cord injury: a focus group study. Rehabil Psychol. 2011 May;56(2):128-37. doi: 10.1037/a0023624. |
| 16507503 | Result | May L, Day R, Warren S. Evaluation of patient education in spinal cord injury rehabilitation: knowledge, problem-solving and perceived importance. Disabil Rehabil. 2006 Apr 15;28(7):405-13. doi: 10.1080/09638280500192439. |
| 23343359 | Result | Scivoletto G, Tamburella F, Laurenza L, Molinari M. The spinal cord independence measure: how much change is clinically significant for spinal cord injury subjects. Disabil Rehabil. 2013 Oct;35(21):1808-13. doi: 10.3109/09638288.2012.756942. Epub 2013 Jan 24. |
| 23031169 | Result | Shepherd JD, Badger-Brown KM, Legassic MS, Walia S, Wolfe DL. SCI-U: e-learning for patient education in spinal cord injury rehabilitation. J Spinal Cord Med. 2012 Sep;35(5):319-29. doi: 10.1179/2045772312Y.0000000044. |
| 18496904 | Result | Wirth B, van Hedel HJ, Kometer B, Dietz V, Curt A. Changes in activity after a complete spinal cord injury as measured by the Spinal Cord Independence Measure II (SCIM II). Neurorehabil Neural Repair. 2008 May-Jun;22(3):279-87. |
| 42165224 | Derived | Abumostafa MK, Plastow NA, Savin-Baden M. Participation Education Intervention for People With SCI From LMIC: A Pilot Randomized Clinical Trial. Occup Ther Int. 2026;2026(1):e8774897. doi: 10.1155/oti/8774897. |
| 35867399 | Derived | Abu Mostafa M, Plastow NA, Savin-Baden M, Ayele B. The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Education Manual (SADL-eM): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jul 22;11(7):e30611. doi: 10.2196/30611. |
| D014947 | Wounds and Injuries |