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Enhanced Medical Rehabilitation for Spinal Cord Injury (EMRSCI Trial)
N/A
Waitlist Available
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Inpatient therapists specializing in SCI for less than six months
Not willing or able to follow study protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the effects of the Enhanced Medical Rehabilitation program on engagement, intensity, and functional and psychosocial outcomes in patients with spinal cord injuries.
Who is the study for?
This trial is for inpatient therapists with at least six months of experience specializing in spinal cord injury (SCI) patients. They must be willing to undergo EMR training, participate in supervision sessions, collect study measures, and consent to being videotaped during therapy sessions.
What is being tested?
The trial tests Enhanced Medical Rehabilitation (EMR), a program designed to boost patient engagement and the intensity of therapy for better functional and psychosocial recovery from SCI. It compares EMR's effectiveness against standard care by randomly assigning patients to either approach.
What are the potential side effects?
Since this intervention involves training methods rather than medications or medical procedures, traditional side effects are not applicable. However, there may be risks associated with increased treatment intensity that will be monitored.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been a therapist for SCI patients for less than 6 months.
Select...
I am unable or unwilling to follow the study's requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Function: Change in Continuity Assessment Record and Evaluation
Secondary study objectives
Depression: Change in Patient Health Questionnaire-9
Life Satisfaction: Change in Satisfaction with Life Scale
Other study objectives
Adherence/Fidelity: Change in Patient Satisfaction & Treatment Fidelity Survey
Adherence/Fidelity: Change in Therapist Adherence Rating Form
Baseline Comorbidity: Charlson Comorbidity Index
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Medical Rehabilitation (EMR)Experimental Treatment1 Intervention
Patients in the EMR group will also receive the recommended rehabilitation therapy, but they will receive therapy only from four therapists who are trained and supervised in EMR. The therapy sessions will follow EMR protocol. EMR is a set of behavioral skills that therapists can incorporate into their daily therapy sessions to increase patient engagement and achieve a high intensity of therapy, thereby improving functional and psychosocial outcomes of patients in medical rehabilitation.
Group II: Standard of Care (SOC)Active Control1 Intervention
The control group for this study will receive rehabilitation therapy that is recommended and provided by the current healthcare structure. The SOC group will receive therapy only from four therapists who are not trained and supervised in EMR. These therapists will be monitored (videotaped or observed) but will not be not asked to do anything differently with their patients. The investigators recognize that spillover of therapist EMR training to untrained therapists is a concern. Thus, the investigators will ask therapists in the EMR group to agree not to share any of the training with non-trained therapists over the course of the study, and the investigators will provide free EMR training to the non-trained therapists once the treatment phase of the study is complete.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enhanced Medical Rehabilitation (EMR)
2022
N/A
~50
Find a Location
Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
208 Previous Clinical Trials
17,945 Total Patients Enrolled
Washington University School of MedicineOTHER
1,991 Previous Clinical Trials
2,295,804 Total Patients Enrolled
Piper Hansen, OTDStudy DirectorShirley Ryan Ability Lab
1 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have worked with inpatient therapists for SCI patients for at least 6 months.I am willing and able to learn and follow electronic medical record training.I have been a therapist for SCI patients for less than 6 months.I am willing and able to learn and follow electronic medical record training.I am unable or unwilling to follow the study's requirements.I have worked with inpatient SCI patients for at least 6 months.I am willing to be videotaped during therapy sessions.Working in one of two SCI units at the SRAL.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (SOC)
- Group 2: Enhanced Medical Rehabilitation (EMR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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