NCT03952416: EMRSCI

Enhanced Medical Rehabilitation for Spinal Cord Injury

Completed NA Last updated 5 August 2024

What this trial tests

NA trial testing Enhanced Medical Rehabilitation (EMR) in Spinal Cord Injuries in 48 participants. Completed in 30 July 2024.

Timeline

15 November 2022

Primary endpoint
15 June 2024

30 July 2024

Quick facts

Lead sponsor	Shirley Ryan AbilityLab
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	48
Start date	15 November 2022
Primary completion	15 June 2024
Estimated completion	30 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Enhanced Medical Rehabilitation (EMR)

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

Shirley Ryan AbilityLab — full company profile →

Who can join

18 and older, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Patient engagement is a cornerstone of patient-centered care. Studies show that an increased level of patient engagement in medical rehabilitation is associated with greater functional recovery. To achieve higher levels of patient engagement, it is important to improve therapists' techniques for goal setting and clinician-therapist communication. Thus, we have developed a manualized intervention for post-acute rehabilitation, Enhanced Medical Rehabilitation (EMR), which is an evidence-based program to increase patient engagement and achieve a greater intensity of therapy, thereby optimizing the patient's functional and psychosocial recovery. EMR is an integrated set of skills for occupational and physical therapists that transform rehabilitation through (1) a patient-directed, interactive approach; (2) increased treatment intensity; and (3) frequent feedback to patients on effort and progress. We have developed training and supervision methods to enable therapists to carry out these skills with high fidelity. In our previous EMR study of older adults in skilled nursing facilities, patients treated by EMR-trained therapists had greater engagement in therapy, higher-intensity therapy sessions, and better functional outcomes. Due to the complexity of the inpatient spinal cord injury (SCI) rehabilitation environment, it is unknown whether the EMR program will be clinically relevant to inpatient rehabilitation settings and acceptable to SCI populations. Therefore, it is necessary to conduct a systematic adaptation approach to address all hospital- and provider-level barriers, and test this adapted program to a new setting (inpatient rehabilitation) and a new population (patients with SCI), without compromising the core elements of the original EMR.

Objective: We propose to adopt the EMR program for use in inpatient SCI rehabilitation settings using an implementation science-driven approach. We also propose a randomized trial of 80 patients with SCI to test the effects of EMR on improving engagement and treatment intensity, as well as functional and psychosocial outcomes over standard of care (SOC) rehabilitation.

Methods: We will randomize patients into EMR or SOC groups. For the EMR group, four therapists will be trained and supervised in EMR and will incorporate EMR techniques into therapy sessions. In the SOC group, four therapists will carry out therapy sessions as usual.

Expected Outcomes: With respect to EMR intervention adaptions, we hypothesize that the EMR program, including a treatment manual and other materials, will be customized with input from our Spinal Cord Injury-Community Advisory Board (SCI-CAB). Patients randomized to EMR will have greater engagement and intensity and greater functional and psychosocial recovery compared to those randomized to SOC rehabilitation.

Significance: The impact is high. EMR is patient-centered rehabilitation, and it is designed for real-world clinical practice. Success in this line of research will improve therapists' skills working with patients and optimizing patient outcomes, ensuring that inpatient SCI rehabilitation is more patient-centered, to the benefit of individuals with SCI.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.