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

Stellenbosch University (SU)

Status

Unknown

Conditions

Spinal Cord Injuries

Treatments

Other: SADL-eM

Study type

Interventional

Funder types

Other

Identifiers

NCT04735887

972225221

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.