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Assessment of Neurorehabilitation in Spinal Cord Injury Using Neuroimage Tools.

Primary Purpose

Injuries, Spinal Cord

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rehabilitation treatment
Sponsored by
Universidade do Vale do Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injuries, Spinal Cord focused on measuring Spinal Cord Injury, Motor rehabilitation, Sensorimotor reorganization, Robotic, Functional magnetic resonance imaging

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with uncontrollable spasticity-induced body movements.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Body Weight Supported Treadmill Training

    Arm Description

    The 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2019
    Last Updated
    April 11, 2019
    Sponsor
    Universidade do Vale do Paraíba
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03914456
    Brief Title
    Assessment of Neurorehabilitation in Spinal Cord Injury Using Neuroimage Tools.
    Official Title
    Assessment of Functional Neurorehabilitation in Spinal Cord Injury Using Fmri and Other Neuroimage Tools.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2, 2007 (Actual)
    Primary Completion Date
    September 2, 2007 (Actual)
    Study Completion Date
    November 15, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidade do Vale do Paraíba

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Motor Rehabilitation The 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. Table 1 shows the initial and final training parameters for each patient. To assess functional ability, each patient was assigned a Walking Index for Spinal Cord Injury (WISCI II) (Ditunno and Ditunno 2001) (Table 1), Manual Muscle Testing and Functional Independence Measure (FIM) before and after the treatment period (Table 2). fMRI Protocol The patients were scanned using a 3T Siemens TIM TRIO system before and after the rehabilitation treatment protocol. The fMRI protocol consisted of a two motor-task fMRI series with the following technical parameters: TE=29 ms; TR=2000 ms, number of slices=36, matrix=128x128, FOV=240 mm, slice thickness= 3 mm; and FA=90º. The patients were given instructions for the motor task they were to perform prior to each scan. The patients were positioned with comfortable pads below the knee to allow the active movement of the ankle. During the functional imaging, each motor activation period was signalled with a short instruction to the subject through the headphones. The motor task for the fMRI exploration of the foot was the 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. The movement performance was controlled visually by two examiners to monitor any movement or apparent change during the rest periods of the non-moving limbs. The patients were oriented to perform the motor task through a voluntary movement. Approximately 15 repetitions were made in each period. Finally, a T1-weighted structural image of the whole brain was acquired to a perfect localization of activation areas. Acquisition parameters of the structural image were TE= 2.98 ms; TR= 2300 ms; T1= 900 ms; matrix= 256x256; FA= 9º; and T voxel=1x1x1 m3.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Injuries, Spinal Cord
    Keywords
    Spinal Cord Injury, Motor rehabilitation, Sensorimotor reorganization, Robotic, Functional magnetic resonance imaging

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Body Weight Supported Treadmill Training
    Arm Type
    Experimental
    Arm Description
    The 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.
    Intervention Type
    Other
    Intervention Name(s)
    rehabilitation treatment
    Primary Outcome Measure Information:
    Title
    Changes in blood oxygen level (BOLD) signal after motor rehabilitation, evaluated by functional magnetic resonance imaging study (fMRI)
    Description
    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.
    Time Frame
    2 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Patients with uncontrollable spasticity-induced body movements.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21537338
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16263963
    Citation
    Winchester 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.
    Results Reference
    background

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    Assessment of Neurorehabilitation in Spinal Cord Injury Using Neuroimage Tools.

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