fMRI In Spinal Cord Injury Patient After Rehabilitation

Spinal Cord Injury Clinical Trial

Official title:

FUNCTIONAL MAGNETIC RESONANCE IMAGING (fMRI) OF THE SENSORIMOTOR CORTEX IN SPINAL CORD INJURY PATIENT AFTER INTENSIVE REHABILITATION INCLUDING ROBOTIC DEVICES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074670
• Other study ID #: PL003
• Status: Completed
• Phase: N/A
• First received: February 17, 2014
• Last updated: February 25, 2014
• Start date: February 2007

Study information

• Verified date: February 2014
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the potential reorganization in the sensorimotor cortex in spinal cord injury (SCI) patients after Body Weight Supported Treadmill Training (BWSTT) associated with conventional motor rehabilitation. The investigators hypothesized that training with weight bearing associated with conventional motor rehabilitation will be able to reorganize the brain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with ASIA C or D and the ability to cooperate with instructions of the motor task required. The motor task was to perform ankle plantar flexion and toe flexion and fingers and thumbs movement of the both sides; they also had to be able to fulfill the general conditions necessary for an MRI exploration.

Exclusion Criteria:

• Patients with uncontrollable spasticity-induced body movements were excluded from the study.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Treadmill gait training
Five days a week, 40 sessions of Kinesiotherapy (passive and active mobilizations, muscle lengthening), Body Weight Supported Treadmill Training, bicycle, manual therapy (with and without assistance of a mechanical device) and daily life activities training.

Locations

Country	Name	City	State
Brazil	Paulo Roberto Garcia Lucareli	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Nove de Julho	Universidade do Vale do Paraíba, University of Barcelona

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical Motor Area	Cortical Motor area in fMRI during motor task.	1 month	Yes
Secondary	Functional Index	Walking Index for Spinal Cord Injury	1 month	Yes