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

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Palestinian Territory, occupied
Study Type
Interventional
Intervention
SADL-eM
Sponsored by
University of Stellenbosch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Occupational therapy, educational intervention, Activities of daily living, Spinal Cord Injury, clinical trials

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hamad Rehabilitation Hospital
  • ElAmal Rehabilitation Hospital
  • ElWafa Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SADL-eM & conventional therapy

Conventional therapy

Arm Description

Patients with SCI treated in an inpatient rehabilitation setting who receive a copy of the SADL-eM in addition to conventional therapy.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Spinal Cord Independence Measure-III (SCIM-III) baseline assessment
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.
Spinal Cord Independence Measure-III (SCIM-III) change after six weeks
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.

Full Information

First Posted
January 22, 2021
Last Updated
January 29, 2021
Sponsor
University of Stellenbosch
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1. Study Identification

Unique Protocol Identification Number
NCT04735887
Brief Title
The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual
Acronym
SADLeM
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Stellenbosch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Occupational therapy, educational intervention, Activities of daily living, Spinal Cord Injury, clinical trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Outcomes Assessor
Masking Description
The research assistant who will perform data collection will be blinded to the patient group.
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SADL-eM & conventional therapy
Arm Type
Experimental
Arm Description
Patients with SCI treated in an inpatient rehabilitation setting who receive a copy of the SADL-eM in addition to conventional therapy.
Arm Title
Conventional therapy
Arm Type
No Intervention
Arm Description
Patients with SCI treated in an inpatient rehabilitation setting who receive conventional therapy.
Intervention Type
Other
Intervention Name(s)
SADL-eM
Other Intervention Name(s)
Spinal Cord Injury Activities of Daily Living Educational Manual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spinal Cord Independence Measure-Self Reported (SCIM-SR) baseline assessment
Description
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.
Time Frame
within 3 days of admission
Title
Spinal Cord Independence Measure-Self Reported (SCIM-SR) change after six weeks
Description
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.
Time Frame
Six weeks after admission
Secondary Outcome Measure Information:
Title
Spinal Cord Independence Measure-III (SCIM-III) baseline assessment
Description
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.
Time Frame
within 3 days of admission
Title
Spinal Cord Independence Measure-III (SCIM-III) change after six weeks
Description
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.
Time Frame
Six weeks after admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moussa Abu Mostafa, Master
Phone
0597401091
Email
moussaabumostafa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moussa Abu Mostafa, Master
Organizational Affiliation
Hamad Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad Rehabilitation Hospital
City
Gaza City
State/Province
Gaza Strip
ZIP/Postal Code
1051
Country
Palestinian Territory, occupied
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafat H Lubad, Board
Phone
00972595425003
Email
rlubbad@hamad.ps
Facility Name
ElAmal Rehabilitation Hospital
City
Khan Yunis
State/Province
Gaza Strip
Country
Palestinian Territory, occupied
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuad Luzon, Master
Phone
0599485898
Email
fuadluzon@yahoo.com
Facility Name
ElWafa Rehabilitation Hospital
City
Zahra City
State/Province
Gaza Strip
ZIP/Postal Code
1051
Country
Palestinian Territory, occupied
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamal Khoswan, PhD
Phone
0598887086
Email
idccenter@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available. Data collected will be used only for analysis and results production.
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The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Educational Manual

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