The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual (SADL-eM): Study Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 5
- 主要终点
- Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research assistant who will perform data collection will be blinded to the patient group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment
时间窗: 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
时间窗: 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.
次要结局
- Spinal Cord Independence Measure-III (SCIM-III) baseline assessment(within 3 days of admission)
- Spinal Cord Independence Measure-III (SCIM-III) change after six weeks(Six weeks after admission)
研究者
Moussa Abu Mostafa
Principal investigator
University of Stellenbosch