Clinical trial NCT04735887: The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Occupational therapy
educational intervention
Activities of daily living
Spinal Cord Injury
clinical trials
Lead sponsor: University of Stellenbosch
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment
timeFrame: within 3 days of admission
measure: Spinal Cord Independence Measure-Self Reported (SCIM-SR) change after six weeks
timeFrame: Six weeks after admission
Secondary outcomes:
measure: Spinal Cord Independence Measure-III (SCIM-III) baseline assessment
timeFrame: within 3 days of admission
measure: Spinal Cord Independence Measure-III (SCIM-III) change after six weeks
timeFrame: Six weeks after admission
Other outcomes:
Locations:
city: Gaza City
country: Palestinian Territory, occupied
facility: Hamad Rehabilitation Hospital
state: Gaza Strip
city: Khan Yunis
country: Palestinian Territory, occupied
facility: ElAmal Rehabilitation Hospital
state: Gaza Strip
city: Zahra City
country: Palestinian Territory, occupied
facility: ElWafa Rehabilitation Hospital
state: Gaza Strip
Study officials:
affiliation: Hamad Rehabilitation Hospital
name: Moussa Abu Mostafa, Master
role: PRINCIPAL_INVESTIGATOR
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