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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual (SADL-eM): Study Protocol for a Randomized Clinical Trial

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: SADL-eM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SADL-eM & conventional therapy<br>Patients with SCI treated in an inpatient rehabilitation setting who receive a copy of the SADL-eM in addition to conventional therapy. | Other: SADL-eM<br>* 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.<br>* Other names: Spinal Cord Injury Activities of Daily Living Educational Manual;|
| No Intervention: Conventional therapy<br>Patients with SCI treated in an inpatient rehabilitation setting who receive conventional therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occupational therapy, educational intervention, Activities of daily living, Spinal Cord Injury, clinical trials