Spinal Stimulation and Gait Training to Improve Mobility in TBI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKessler Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have weakness on at least one side of my body.
No injury to my unaffected side in 6 months.
Be cleared by a physician to participate in this study.
Have had a non-penetrating TBI at least 2 years ago. A non-penetrating injury is an injury where my skull remained closed and no object entered it.
Disqualifiers
Have must have not had physical or occupational therapy or treatment for a balance disorder within 30 days prior to study enrollment. I must not participate in physical or occupation therapy throughout the duration of the study to avoid affecting the study results.
Have any medical issues that affect my unaffected side (such arthritis, fracture, etc.).
Have skin issues that would prevent me from being able to use the surface stimulation (such as a open wound or rash).
Have a pre-existing condition that may make it difficult for me to participate in exercise. (uncontrolled hypertension as described by a physician, heart disease, abnormal heart rate or rhythm, or congestive heart failure).
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Spinal Cord Stimulation
Procedure/SurgeryA portable transcutaneous spine stimulator (Digitimer ®, USA) will supply biphasic stimulation superficial to the thoracolumbar spine.
Sham
Other interventionA portable transcutaneous spine stimulator (Digitimer ®, USA) will be applied superficially with no electrical current.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: TBI with StimExperimental treatment 1 intervention
Group B: TBI with ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kessler Foundation
Lead sponsor
Shirley Ryan AbilityLab
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: