Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-08-31

Brief Summary

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PROMPT-SCI (Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older who have sustained a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L1 and undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. The feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. Patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.

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Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early in-bed leg cycling

Group Type EXPERIMENTAL

Leg ergometer

Intervention Type DEVICE

Leg cycling in bed using motorized ergometer

Interventions

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Leg ergometer

Leg cycling in bed using motorized ergometer

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Blunt traumatic spinal cord injury
* Neurological level of injury from C0 to L2
* American Spinal Injury Association impairment scale grade A, B or C
* Spine surgery performed within 48 hours of injury

Exclusion Criteria

* Condition limiting patient's ability to engage into cycling
* Medical condition that might interfere with patient's safety if cycling
* Moderate or severe brain injury
* Inability to walk independently prior to injury
* Pre-existing neurological disorder
* Complete spinal cord transection
* Unwilling or unable to comply with scheduled follow-up

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No