Assessment of Neurorehabilitation in Spinal Cord Injury Using Neuroimage Tools.
Assessment of Functional Neurorehabilitation in Spinal Cord Injury Using Fmri and Other Neuroimage Tools.
1 other identifier
interventional
7
0 countries
N/A
Brief Summary
The sensorimotor cortex may play a role in the functional recovery after Spinal Cord Injury (SCI) through efference generated in the absence of the afference. OBJECTIVE: The purpose of this study was to evaluate the potential reorganization in the sensorimotor cortex in SCI patients after Body Weight Supported Treadmill Training (BWSTT) associated with conventional motor rehabilitation. METHOD: Seven SCI patients with ASIA C and D participated in this study. They were submitted to a motor-task functional magnetic resonance imaging study (fMRI) before and after the rehabilitation treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2007
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2007
CompletedFirst Submitted
Initial submission to the registry
March 29, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedApril 16, 2019
February 1, 2007
7 months
March 29, 2019
April 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in blood oxygen level (BOLD) signal after motor rehabilitation, evaluated by functional magnetic resonance imaging study (fMRI)
The blood oxygen level (BOLD) signal in the sensorimotor area, before and after motor rehabilitation, was evaluated by functional magnetic resonance imaging study (fMRI). The signals were obtained through the motor task of the foot: ankle plantar flexion and toe flexion. The block design began with a 20 second rest period, followed by 30 second periods of movement of the right foot, 30 seconds of the left foot movement and 10 seconds of rest. This cycle was repeated three times.
2 hour
Study Arms (1)
Body Weight Supported Treadmill Training
EXPERIMENTALThe rehabilitation program consisted of five hours per day of the treatment, five times a week for two months (40 sessions). The treatment protocol included kinesiotherapy (passive and active mobilizations, muscle lengthening), BWSTT, bicycle, manual therapy (with and without assistance of a mechanical device) and daily life activities training. The duration of each event was approximately one hour. The initial time of the treatment on the BWSTT was 20 minutes, and the modification of the time depended on the endurance and capability of each patient. Training charge began at 40% body weight supported and at treadmill speeds of at least 1.5 km per hour. The treadmill speed was increased progressively to 2.5 km per hour, and the level of weight supported was adjusted within sessions to achieve knee extension.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with ASIA C or D (Table 1) and the ability to cooperate with instructions of the motor task required. The motor task was to perform ankle plantar flexion, toe flexion and fingers and thumbs movement of both sides; they also had to be able to fulfill the general conditions necessary for an MRI exploration.
You may not qualify if:
- Patients with uncontrollable spasticity-induced body movements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Lucareli PR, Lima MO, Lima FP, de Almeida JG, Brech GC, D'Andrea Greve JM. Gait analysis following treadmill training with body weight support versus conventional physical therapy: a prospective randomized controlled single blind study. Spinal Cord. 2011 Sep;49(9):1001-7. doi: 10.1038/sc.2011.37. Epub 2011 May 3.
PMID: 21537338BACKGROUNDWinchester P, McColl R, Querry R, Foreman N, Mosby J, Tansey K, Williamson J. Changes in supraspinal activation patterns following robotic locomotor therapy in motor-incomplete spinal cord injury. Neurorehabil Neural Repair. 2005 Dec;19(4):313-24. doi: 10.1177/1545968305281515.
PMID: 16263963BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2019
First Posted
April 16, 2019
Study Start
February 2, 2007
Primary Completion
September 2, 2007
Study Completion
November 15, 2007
Last Updated
April 16, 2019
Record last verified: 2007-02
Data Sharing
- IPD Sharing
- Will not share