CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Experimental: Implementation of an intensive therapeutic group exercise program in the neurorehabilitation processother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT06624566
NCT06624566N/ACompleted

EINTER PROGRAM: Intensive Therapeutic Exercise in Patients With Spinal Cord Injury.

Instituto de Investigación Sanitaria Aragón·interventional·Posted Oct 3, 2024·Updated Feb 6, 2025

In Brief

A clinical study evaluating Experimental: Implementation of an intensive therapeutic group exercise program in the neurorehabilitation process for Spinal Cord Injury. Completed, enrolled 63 participants across 1 site.

Detailed Summary

This study consists of the implementation of a therapeutic physical exercise program in a group setting in patients with spinal cord injury admitted to the Miguel Servet University Hospital in Zaragoza. This program consists of performing strength and endurance exercises from Monday to Friday with a duration of approximately 45 minutes each session. The groups are created in such a way that the subjects in each group are homogeneous. This homogeneity is classified according to whether or not trunk control in seated or standing position is maintained in an autonomous manner as measured by the Berg scale. Each group consists of a maximum of 4 subjects and there are a maximum of 2 groups, and 1 physiotherapist per group. Group A is for those subjects who do not maintain independent standing, but maintain trunk control while seated, and group B is for those patients who do maintain independent standing. Prior to the start of the program, subjects are informed of the study and evaluated with a series of health indicators (scales) to measure the impact of the program at the beginning of the program and at hospital discharge. These scales are as follows: To measure muscular strength the investigators use the Medical Research Council, and to measure aerobic endurance the investigators use the 6 Minute Walking Test for patients who can ambulate autonomously and the 6 Minutes Pushing Test for those patients who do not ambulate and move around in a wheelchair. In addition, the investigators pass a satisfaction

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedOct 3, 2024
Enrollment StartJan 1, 2024
Primary CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 1.7 years ago

Interventions

Experimental: Implementation of an intensive therapeutic group exercise program in the neurorehabilitation processother

Description: The variables will be measured prior to group assignment The age and sex variables and the satisfaction survey will be measured at the beginning of the program, the other variables at 20 sessions, at 40 sessions, at 60 sessions and/or at hospital discharge. Before the patient starts the program, he/she is classified in group A - patients who have seated trunk control for at least 2 minutes (with supervision) and no standing control (Berg scale item 3.3) - or in group B - patients who have standing trunk control for 2 minutes (with supervision) (Berg scale item 2.3). There is a maximum of 4 patients per group with 1 physiotherapist per group.. There is a maximum of 4 patients per group with 1 physiotherapist per group.. The difference with respect to the usual treatment of the neurorehabilitation service of the HMS is that in the EINTER program, strength and endurance exercises will be implemented in addition to the usual care plan