Recruitment

Recruitment Status
Terminated
Estimated Enrollment
28

Inclusion Criterias

Ability to Dorsiflex (Move foot up) at least 5 degrees from sitting.
Motor incomplete Spinal cord injured subjects.
Ability to walk 10 m with or without walking aides.
Ability to Dorsiflex (Move foot up) at least 5 degrees from sitting.
Motor incomplete Spinal cord injured subjects.
Ability to walk 10 m with or without walking aides.

Exclusion Criterias

Seizures
Brain surgery or intracranial metal implants.
Cognitive function impairment
Seizures
Brain surgery or intracranial metal implants.
Cognitive function impairment

Summary

Conditions
Spinal Cord Injury
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

An estimated 265,000 individuals live with the consequences of SCI in the United States alone. Individuals with motor incomplete spinal cord injury (MISCI) commonly experience loss or impairment of lower extremity function. There are a limited number of options for restoration of walking function in...

An estimated 265,000 individuals live with the consequences of SCI in the United States alone. Individuals with motor incomplete spinal cord injury (MISCI) commonly experience loss or impairment of lower extremity function. There are a limited number of options for restoration of walking function in individuals with motor-incomplete spinal cord injury (MISCI) who exhibit some ability to stand and walk but may be impeded by impaired voluntary control of the lower limb particularly, the ankle. In persons with spinal cord injury, walking function is often limited by poor ability to lift and advance the legs. Lower extremity orthotic devices may be employed to stabilize the ankle joint and provide toe clearance during walking. However, these devices are cumbersome, and may be aesthetically unappealing. Newer evidence indicates that non-invasive approaches to brain stimulation may provide a way to improve voluntary control of the legs and ankles in persons with neurologic disorders. Purpose of this research study: The overall goal of this study is to develop functional rehabilitation strategies that facilitate optimal restoration of leg and ankle motor control in individuals with MISCI. Individuals with MISCI exhibit some motor function below the level of lesion and include American Spinal Injury Association Impairment Scale (AIS) classifications AIS C and AIS D. We propose to test non-invasive cortical stimulation in combination with lower-extremity functional motor training for its ability to assist in improving fine motor control of the lower limbs in individuals with MISCI. Studies have shown that non-invasive transcranial direct current stimulation (tDCS) can increase activity in specific cortical areas associated with motor learning, and therefore improve on the cortical and functional effects associated with motor practice training in individuals with SCI. If brain stimulation in combination with motor training is found to enhance improvements in control more effectively than motor training alone, this would provide a basis for further examining stimulation combined with lower limb joint therapy in individuals with spinal cord injury. Objectives: To Assess improvements in lower extremity motor control that are associated with bilateral tDCS and functional motor training or sham tDCS and functional motor training in individuals with motor incomplete spinal cord injury.

Inclusion Criterias

Ability to Dorsiflex (Move foot up) at least 5 degrees from sitting.
Motor incomplete Spinal cord injured subjects.
Ability to walk 10 m with or without walking aides.
Ability to Dorsiflex (Move foot up) at least 5 degrees from sitting.
Motor incomplete Spinal cord injured subjects.
Ability to walk 10 m with or without walking aides.

Exclusion Criterias

Seizures
Brain surgery or intracranial metal implants.
Cognitive function impairment
Seizures
Brain surgery or intracranial metal implants.
Cognitive function impairment

Locations

Miami, Florida, 33136
Miami, Florida, 33136

Tracking Information

NCT #
NCT01962675
Collaborators
Not Provided
Investigators
  • Principal Investigator: Edelle C Field Fote, PhD University of Miami
  • Edelle C Field Fote, PhD University of Miami