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

Not Applicable

• Conditions: Spinal Cord Injuries
• Interventions: Other: SADL-eM

• Registration Number: NCT04735887
• Lead Sponsor: University of Stellenbosch

Brief 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.

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 Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-29
• Last Update Submitted: 2021-01-29
• Study Start: 2021-02-01
• Study First Posted: 2021-02-03
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SADL-eM & conventional therapy	SADL-eM	Patients with SCI treated in an inpatient rehabilitation setting who receive a copy of the SADL-eM in addition to conventional therapy.

Primary Outcome Measures

Name	Time	Method
Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment	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	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.

Secondary Outcome Measures

Name	Time	Method
Spinal Cord Independence Measure-III (SCIM-III) baseline assessment	within 3 days of admission	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.
Spinal Cord Independence Measure-III (SCIM-III) change after six weeks	Six weeks after admission	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.

Trial Locations

Locations (3)

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, Palestinian Territory, occupied