Back to resultsfMRI In Spinal Cord Injury Patient After Rehabilitation
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Treadmill gait training
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
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.
Sites / Locations
- Paulo Roberto Garcia Lucareli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treadmill gait training
Arm Description
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.
Outcomes
Primary Outcome Measures
Cortical Motor Area
Cortical Motor area in fMRI during motor task.
Secondary Outcome Measures
Functional Index
Walking Index for Spinal Cord Injury
Full Information
NCT ID
NCT02074670
First Posted
February 17, 2014
Last Updated
February 25, 2014
Sponsor
University of Nove de Julho
Collaborators
Universidade do Vale do Paraíba, University of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT02074670
Brief Title
fMRI In Spinal Cord Injury Patient After Rehabilitation
Official Title
FUNCTIONAL MAGNETIC RESONANCE IMAGING (fMRI) OF THE SENSORIMOTOR CORTEX IN SPINAL CORD INJURY PATIENT AFTER INTENSIVE REHABILITATION INCLUDING ROBOTIC DEVICES
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Universidade do Vale do Paraíba, University of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treadmill gait training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treadmill gait training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cortical Motor Area
Description
Cortical Motor area in fMRI during motor task.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Functional Index
Description
Walking Index for Spinal Cord Injury
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Paulo Roberto Garcia Lucareli
City
São Paulo
ZIP/Postal Code
02020000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
fMRI In Spinal Cord Injury Patient After Rehabilitation
We'll reach out to this number within 24 hrs