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

NCT04735887 | Unknown

• 1 other identifier: 972225221
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

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.

Conditions

Spinal Cord Injuries

Keywords

Occupational therapy; educational intervention; Activities of daily living; Spinal Cord Injury; clinical trials

Outcome Measures

Primary Outcomes (2)

• Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment

  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

  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 Outcomes (2)

• 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

Study Arms (2)

SADL-eM & conventional therapy

EXPERIMENTAL

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

Conventional therapy

NO INTERVENTION

Patients with SCI treated in an inpatient rehabilitation setting who receive conventional therapy.

Interventions

SADL-eM OTHER

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.

Also known as: Spinal Cord Injury Activities of Daily Living Educational Manual

SADL-eM & conventional therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Stellenbosch: lead

Study Sites (3)

Hamad Rehabilitation Hospital

Gaza, Gaza Strip, 1051, Palestinian Territories

Location

ElAmal Rehabilitation Hospital

Khan Yunis, Gaza Strip, Palestinian Territories

Location

ElWafa Rehabilitation Hospital

Zahra City, Gaza Strip, 1051, Palestinian Territories

Location

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Moussa Abu Mostafa, Master

  Hamad Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moussa Abu Mostafa, Master

CONTACT

0597401091; moussaabumostafa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant who will perform data collection will be blinded to the patient group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 3, 2021
• Study Start: February 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (3)