The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual

Spinal Cord Injuries Clinical Trial

— SADLeM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04735887
• Other study ID #: 972225221
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: University of Stellenbosch
• Contact: Moussa Abu Mostafa, Master
• Phone: 0597401091
• Email: moussaabumostafa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• SADL-eM
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.

Locations

Country	Name	City	State
Palestinian Territory, occupied	Hamad Rehabilitation Hospital	Gaza City	Gaza Strip
Palestinian Territory, occupied	ElAmal Rehabilitation Hospital	Khan Yunis	Gaza Strip
Palestinian Territory, occupied	ElWafa Rehabilitation Hospital	Zahra City	Gaza Strip

Sponsors (1)

Lead Sponsor	Collaborator
University of Stellenbosch

Country where clinical trial is conducted

Palestinian Territory, occupied, 

References & Publications (24)

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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

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

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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