Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shirley Ryan AbilityLab | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBI with Stim | Experimental | Participants with TBI will be asked to come in 3 days a week for 6 weeks for walking training provided by a trained, licensed physical therapist. Electrodes will be placed on the surface of the skin along the spinal cord to provide stimulation during walking. |
|
| TBI with Sham | Sham Comparator | Participants with TBI will be asked to come in 3 days a week for 6 weeks for walking training provided by a trained, licensed physical therapist. Electrodes will be placed on the surface of the skin along the spinal cord but will not provide stimulation during walking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Spinal Cord Stimulation | Procedure | A portable transcutaneous spine stimulator (Digitimer ®, USA) will supply biphasic stimulation superficial to the thoracolumbar spine. |
| Measure | Description | Time Frame |
|---|---|---|
| 10MWT (Aim 1) | 10 meter walk test is a timed test to evaluate walking speed after TBI and in response to the intervention. | 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. | 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. | 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. | 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. | 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. | Change from Baseline at 6 weeks and 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Franco | Contact | 973-324-3521 | sfranco@kesslerfoundation.org | |
| Kathleen Goworek | Contact | 973-324-3560 | kgoworek@kesslerfoundation.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D006429 | Hemiplegia |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham | Other | A portable transcutaneous spine stimulator (Digitimer ®, USA) will be applied superficially with no electrical current. |
|
| Joint Range of Motion (kinematics) (Aim 2) | Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes. | 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). | 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. | 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. | 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. | 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. | 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. | Change from Baseline at 6 weeks and 3 months |
| Kessler Foundation | West Orange | New Jersey | 07052 | United States |
|
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |