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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
Willing and able to participate in EMR training and supervision sessions
Inpatient therapists specializing in SCI patients for at least six months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
EMRSCI Trial Summary
This trial will test whether a manualized intervention called Enhanced Medical Rehabilitation (EMR) can improve patient engagement and outcomes in inpatient rehabilitation for people 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 collect study data, be videotaped during therapy sessions, and participate in training and supervision for Enhanced Medical Rehabilitation (EMR). Therapists new to SCI specialization or unable to follow the study protocol are excluded.Check my eligibility
What is being tested?
The trial tests EMR, a program designed to increase patient engagement and intensity of therapy for better functional and psychosocial recovery in SCI patients. It compares EMR's effectiveness against standard care by randomizing patients into two groups: one receiving EMR from trained therapists, the other receiving usual care.See study design
What are the potential side effects?
Since this intervention involves training methods rather than medications or invasive procedures, traditional side effects are not applicable. However, there may be risks associated with increased therapy intensity such as muscle soreness or fatigue.
EMRSCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to learn and follow electronic medical record training.
Select...
I have worked with inpatient SCI patients for at least 6 months.
EMRSCI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Function: Functional Independence Measure
Secondary outcome measures
Depression: Patient Health Questionnaire-9
Life Satisfaction: Satisfaction with Life Scale
EMRSCI 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.
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Who is running the clinical trial?
Washington University School of MedicineOTHER
1,926 Previous Clinical Trials
2,296,802 Total Patients Enrolled
Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,805 Total Patients Enrolled
Piper Hansen, OTDStudy DirectorShirley Ryan Ability Lab
1 Previous Clinical Trials
80 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to learn and follow electronic medical record training.Working at one of two spinal cord injury units at the SRAL.I am unable or unwilling to follow the study's requirements.I have worked with inpatient SCI patients for at least 6 months.I have been a therapist for SCI patients for less than 6 months.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available in this clinical research opportunity?
"Per the information shared on clinicaltrials.gov, this medical trial is not currently open for recruitment. It had first been listed on November 15th 2022 and was last updated October 24th 2022. Although closed off to enrollees, there are a plethora of other trials still recruiting at this time, with 909 openings available in total."
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