NCT02074670

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

February 17, 2014

Last Update Submit

February 25, 2014

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Cortical Motor Area

    Cortical Motor area in fMRI during motor task.

    1 month

Secondary Outcomes (1)

  • Functional Index

    1 month

Study Arms (1)

Treadmill gait training

EXPERIMENTAL

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

Interventions

Treadmill gait trainingOTHER

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.

Treadmill gait training

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paulo Roberto Garcia Lucareli

São Paulo, São Paulo, 02020000, Brazil

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2014

First Posted

February 28, 2014

Study Start

February 1, 2007

Primary Completion

February 1, 2008

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

BR(1)