The purpose of this research study is to assess the effects of receiving transcutaneous spinal stimulation while performing walking exercises compared to completing walking exercises without spinal stimulation for individuals with hemiplegic TBI.
The fundamental hypothesis guiding this proposal is that transcutaneous spinal cord stimulation combined with gait training for individuals with hemiplegic TBI will lead to improved: modulation of corticospinal networks, functional mobility, gait symmetry, standing posture, balance, and motor efficiency compared to gait training with sham stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
A portable transcutaneous spine stimulator (Digitimer ®, USA) will supply biphasic stimulation superficial to the thoracolumbar spine.
A portable transcutaneous spine stimulator (Digitimer ®, USA) will be applied superficially with no electrical current.
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Kessler Foundation
West Orange, New Jersey, United States
10MWT (Aim 1)
10 meter walk test is a timed test to evaluate walking speed after TBI and in response to the intervention.
Time frame: Change from Baseline 10MWT at 6 weeks and 3 months
6MWT (Aim 1)
6 minute walking test to evaluate endurance after TBI and in response to the intervention. Distance is measured for 6 minutes with a greater distance indicating a better outcome.
Time frame: Change from Baseline 6MWT at 6 weeks and 3 months
TUG (Aim 1)
Timed up and go (TUG) is a timed test to measure functional balance and walking ability after TBI and in response to the intervention.
Time frame: Change from Baseline 6MWT at 6 weeks and 3 months
DGI (Aim 1)
Dynamic Gait Index (DGI) evaluates the ability to modify balance while walking in the presence of external demands after TBI and in response to the intervention. The measure is scored out of 24 with a higher score indicating a better outcome.
Time frame: Change from Baseline DGI at 6 weeks and 3 months
Berg Balance Scale (Aim 1)
Measure to assess static and dynamic balance and fall risk after TBI and in response to the intervention. The scale is scored out of 56 with a high score indicating a better outcome.
Time frame: Change from Baseline Berg at 6 weeks and 3 months
Temporospatial Loading (Aim 1)
Step length, timing during gait cycle, limb symmetry will be collected using instrumented gait walkway and are combined to evaluate gait symmetry.
Time frame: Change from Baseline at 6 weeks and 3 months
Joint Range of Motion (kinematics) (Aim 2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes.
Time frame: Change from Baseline at 6 weeks and 3 months
Transcranial magnetic stimulation (TMS) (Aim 2)
Transcranial magnetic stimulation (TMS) will be used to assay changes in cortical neurophysiology for all subjects using Magstim Rapid2TM 70 mm double coil (or similar device).
Time frame: Change from Baseline at 6 weeks and 3 months
Participation Objective Participation Subjective (Aim 3)
The POPS consists of 26 elements of participation representing 5 categories. For each item the participant rates each element objectively and subjectively.
Time frame: Change from Baseline at 6 weeks and 3 months
Community Integration Questionnaire (Aim 3)
The CIQ is a 15-item instrument used to assess the social role limitations and community interaction of people with brain injury with higher scores indicating greater independence and community integration.
Time frame: Change from Baseline at 6 weeks and 3 months
Patient Competency Rating Scale (Aim 3)
The PCRS is a 30 item self report scale using a 5 point Likert to rate the degree of difficulty in a variety of tasks and functions including measure of awareness of deficits following TBI in daily living, behavioral and emotional function, cognitive abilities, and physical function. Higher score indicates greater competency.
Time frame: Change from Baseline at 6 weeks and 3 months
Perceived Control Scale for Brain Injury (Aim 3)
This scale is 9 items scored on a 4 point Likert. It measures perceived control developed for individuals with acquired brain injury with a higher score indicating higher perceived control.
Time frame: Change from Baseline at 6 weeks and 3 months
SF-36 (Aim 3)
The Short Form (SF) Survey is the most widely used and studied measure of health-related quality of life consisting of 36 items, completed by the participant. Higher average scores indicate a more favorable state of health.
Time frame: Change from Baseline at 6 weeks and 3 months