Spinal Cord InjuriesSADLeMNCT04735887
The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual
A study testing SADL-eM in people with Spinal Cord Injuries, run by University of Stellenbosch at 3 sites in Palestinian Territories.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- SADL-eM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesPalestinian Territories
- Study dates
- 1 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed SCI diagnosis by computed tomography or magnetic resonance report.
- ASIA: A, B, and C
- Age between 18 and 65 years old.
- Stable medical condition.
- Time elapsed after SCI is not more than 6 months.
- Minimum time of stay in the inpatient rehabilitation unit is six weeks.
- Active involvement in the rehabilitation program.
- Sufficient comprehension (read/write) of the Arabic language.
Who cannot join
- Unconfirmed diagnosis.
- Patients who have communication and/or cognitive disorders such as global aphasia and memory deficit.
- Patients with a disturbed level of awareness such as coma or lethargy.
- Time elapsed since SCI is more than 6 months.
- ASIA: D and E
- Unstable medical condition.
Show all 15Show fewer
- Patients who have other cause(s) of disability in addition to SCI such as stroke or amputation.
- Age less than 18 or more than 65 years old.
- Time of stay in the inpatient rehabilitation unit is less than six weeks.
- Inactive involvement in the rehabilitation program.
- Patients with progressive disease or a psychiatric condition that would interfere with active participation in the rehabilitation programs.
- Patients with cardiovascular contraindications.
- Persons who become walking ambulatory during the inpatient period.
- Persons with complete tetraplegia C4 or above.
- Persons on a mechanical ventilator.
Trial locations and contacts
3 sites in 1 country.
Palestinian Territories3 sites
Hamad Rehabilitation Hospital
Gaza, Gaza Strip, 1051
Rafat H Lubad, Board, 00972595425003, rlubbad@hamad.ps
ElAmal Rehabilitation Hospital
Khan Yunis, Gaza Strip
Fuad Luzon, Master, 0599485898, fuadluzon@yahoo.com
ElWafa Rehabilitation Hospital
Zahra City, Gaza Strip, 1051
Jamal Khoswan, PhD, 0598887086, idccenter@hotmail.com
About this study
Official title: The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual (SADL-eM): Study Protocol for a Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- SADL-eM
- Keywords
- Occupational therapy, educational intervention, Activities of daily living, Spinal Cord Injury, clinical trials
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SADL-eMOther
Also called Spinal Cord Injury Activities of Daily Living Educational Manual
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: SADL-eM |
| Conventional therapy | No intervention | Patients with SCI treated in an inpatient rehabilitation setting who receive conventional therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Six weeks after admission
Secondary outcomes (2)
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.
Measured: within 3 days of admission
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.
Measured: Six weeks after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moussa Abu Mostafa, University of Stellenbosch
- Investigators
- Moussa Abu Mostafa, Master, Principal investigator, Hamad Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735887
- Sponsor's protocol ID
- 972225221
- Acronym
- SADLeM
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available. Data collected will be used only for analysis and results production.
Publications
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.
PubMed 30616508Bell 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.
PubMed 29403314Bodling, 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
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.
PubMed 30487829DiSilvio B, Virani A, Patel S, Finoli L, Singh A, DuMont T, Cheema T. Institutional COVID-19 Protocols: Focused on Preparation, Safety, and Care Consolidation. Crit Care Nurs Q. 2020 Oct/Dec;43(4):413-427. doi: 10.1097/CNQ.0000000000000327.
PubMed 32833778Faul 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.
PubMed 17695343Fekete 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.
PubMed 22890418Krueger 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.
PubMed 15388912Fetzer 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.
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.
PubMed 19774305Itzkovich 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.
PubMed 28895576Moher 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.
PubMed 20332511Mostafa, 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
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
Polit, D. F., Beck, C. T. and Hungler, B. P. (2001). Essentials of Nursing Research: Methods, Appraisals, and Utilization. Fifth edition.: Lippincott, USA.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual (SADL-eM): Study Protocol for a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04735887
- Acronym / sponsor ID
- SADLeM / 972225221
- Conditions
- Spinal Cord Injuries
- Keywords
- Occupational therapy, educational intervention, Activities of daily living, Spinal Cord Injury, clinical trials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Feb 2021 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| SADL-eM & conventional therapy | Experimental | Other: SADL-eMPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed SCI diagnosis by computed tomography or magnetic resonance report.
- ASIA: A, B, and C
- Age between 18 and 65 years old.
- Stable medical condition.
- Time elapsed after SCI is not more than 6 months.
Key exclusion criteria (15 listed)
- Unconfirmed diagnosis.
- Patients who have communication and/or cognitive disorders such as global aphasia and memory deficit.
- Patients with a disturbed level of awareness such as coma or lethargy.
- Time elapsed since SCI is more than 6 months.
- ASIA: D and E
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SADL-eMAlso: Spinal Cord Injury Activities of Daily Living Educational ManualThe 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. | Other | SADL-eM & conventional therapy |
Primary outcome
Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment
Time frame: within 3 days of admission
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.
Spinal Cord Independence Measure-Self Reported (SCIM-SR) change after six weeks
Time frame: Six weeks after admission
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.
2 secondary outcomes
Spinal Cord Independence Measure-III (SCIM-III) baseline assessment
Time frame: within 3 days of admission
Spinal Cord Independence Measure-III (SCIM-III) change after six weeks
Time frame: Six weeks after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 30616508Magill 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.
- Background: PubMed 29403314Bell 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.
- BackgroundBodling, 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
- Background: PubMed 30487829De 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.
- Background: PubMed 32833778DiSilvio B, Virani A, Patel S, Finoli L, Singh A, DuMont T, Cheema T. Institutional COVID-19 Protocols: Focused on Preparation, Safety, and Care Consolidation. Crit Care Nurs Q. 2020 Oct/Dec;43(4):413-427. doi: 10.1097/CNQ.0000000000000327.
- Background: PubMed 17695343Faul 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.
- Background: PubMed 22890418Fekete 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.
- Background: PubMed 15388912Krueger 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.
- BackgroundFetzer 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.
- Background: PubMed 19774305Glass 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.
- Background: PubMed 28895576Itzkovich 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.
- Background: PubMed 20332511Moher 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.
- Individual participant dataSharing planned: No. There is no plan to make IPD available. Data collected will be used only for analysis and results production.
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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.
Moussa Abu Mostafa, Master principal investigator
Hamad Rehabilitation Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SADL-eM in people with Spinal Cord Injuries, run by University of Stellenbosch at 3 sites in Palestinian Territories.
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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Palestinian Territories. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moussa Abu Mostafa, Master (0597401091, moussaabumostafa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment (time frame: within 3 days of admission). 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?
On the ClinicalTrials.gov record for NCT04735887, which also lists 26 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 3 Feb 2021.