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

January 29, 2021 updated by: Moussa Abu Mostafa, University of Stellenbosch

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Palestinian Territory, occupied
    • Gaza Strip
      • Gaza City, Gaza Strip, Palestinian Territory, occupied, 1051
        • Hamad Rehabilitation Hospital
      • Khan Yunis, Gaza Strip, Palestinian Territory, occupied
        • ElAmal Rehabilitation Hospital
      • Zahra City, Gaza Strip, Palestinian Territory, occupied, 1051
        • ElWafa Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SADL-eM & conventional therapy
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
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.
Other Names:
  • Spinal Cord Injury Activities of Daily Living Educational Manual
No Intervention: Conventional therapy
Patients with SCI treated in an inpatient rehabilitation setting who receive conventional therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment
Time Frame: 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.
within 3 days of admission
Spinal Cord Independence Measure-Self Reported (SCIM-SR) change after six weeks
Time Frame: 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.
Six weeks after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal Cord Independence Measure-III (SCIM-III) baseline assessment
Time Frame: 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.
within 3 days of admission
Spinal Cord Independence Measure-III (SCIM-III) change after six weeks
Time Frame: 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.
Six weeks after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Stellenbosch

Investigators

  • Principal Investigator: Moussa Abu Mostafa, Master, Hamad Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 972225221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to make IPD available. Data collected will be used only for analysis and results production.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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