fMRI In Spinal Cord Injury Patient After Rehabilitation

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Other: Treadmill gait training

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 02020000
    • Paulo Roberto Garcia Lucareli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical Motor Area	Cortical Motor area in fMRI during motor task.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Index	Walking Index for Spinal Cord Injury	1 month

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: Universidade do Vale do Paraíba; University of Barcelona

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: February 17, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (Estimate): February 28, 2014

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: February 25, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: PL003