Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
Primary Purpose
Incomplete Spinal Cord Injury, Spasticity, Muscle
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motor Skill Training (MST)
Transcutaneous Spinal Stimulation (TSS)
Cyclic Aerobic Exercise (CAX)
Sponsored by
About this trial
This is an interventional treatment trial for Incomplete Spinal Cord Injury focused on measuring spinal, cord, incomplete, motor, skill, training, transcutaneous, stimulation, TSS, tSCS, electrophysiology
Eligibility Criteria
Inclusion Criteria:
- Have a spinal cord injury (neurological level T12 or above)
- Sub-acute to Chronic SCI (3 months or greater)
- Neurological impairment classification C or D
- Able to stand for at least 5 minutes (with or without an assistive device)
- Able to move each leg independently for at least 3 steps
- Able to rise from sit to stand with no more than moderate assistance from one person
- Ability and willingness to consent and authorize use of personal health information
Exclusion Criteria:
- Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord
- Injuries below the neurological spinal level of T12
- Pregnancy, or if you have reason to believe you are or may become pregnant due to unknown risks to the fetus associated with TSS
- History of uncontrolled cardiovascular condition
- Altered cognitive status
- Presence of orthopedic conditions that would adversely affect participation in exercise
- History of seizures
- Inability and unwillingness to consent and authorize use of personal health information
Sites / Locations
- Shepherd CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
MST + TSS
MST + ShamTSS
CAX + TSS
Arm Description
Individuals will participate in 6 training sessions of MST combined with TSS.
Individuals will participate in 6 training sessions of MST while receiving shamTSS.
Individuals will participate in 6 training sessions of CAX while receiving TSS
Outcomes
Primary Outcome Measures
Change in 10 Meter Walk Test
Walking speed (as determined by the 10MWT) is the primary outcome measure for assessing walking function. Participants will complete 3 10MWT trials at each testing session, separated by 2 minutes of seated rest. The average walking speed of the 3 walks will be calculated and used in the analyses.
Secondary Outcome Measures
Change of Spatiotemporal Gait Characteristic (Cadence)
Gait quality will be assessed from spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] of the weaker and stronger limbs, and step length symmetry) collected via instrumented walkway as participants completed three, 10MWT trials at each testing session. The average cadence across three walks will be used in the analysis.
Change of Spatiotemporal Gait Characteristic (Stride Length - Both Lower Extremities)
Gait quality will be assessed from spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] of the weaker and stronger limbs, and step length symmetry) collected via instrumented walkway as participants completed three, 10MWT trials at each testing session. The average stride length across three walks will be used in the analysis.
Change of Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)
Gait quality will be assessed from spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] of the weaker and stronger limbs, and step length symmetry) collected via instrumented walkway as participants completed three, 10MWT trials at each testing session. The average step length for each leg across three walks will be used to compute the symmetry index (%).
Change of Berg Balance Scale
Balance will be measured using the BBS. The BBS total score will be calculated for each participant at each testing session. The total range of scores for the BBS equals 0-56, with higher scores from baseline indicating greater balance performance and lower scores from baseline indicating worsened balance performance. A subset of the BBS will be assess before and after each training session.
Change of Falls Efficacy Scale-International Version (FES-I)
The FES-I total score will be calculated for each participant at each testing session to measure fear of falling. The total range of scores for the FES-I equals 16-64, with lower scores indicating decreased fear of falling.
Change of Spinal Cord Assessment Tool for Spastic Reflexes
The SCATS will be used to assess spasticity. The total range of scores possible for the SCATS is 0-18, with a total score of 0 indicating no lower limb spasticity and higher total scores indicating greater spasticity severity.
Change of Modified 5-Times Sit-to-Stand
The modified 5-times sit-to-stand test will be used as a measure of functional lower extremity strength. The average time to complete the test will be calculated at each testing session.
Change of 2 Minute Walk Test
Functional walking capacity will be measured based on the 2MWT distance. Total distance walked in 2-minutes will be recorded for each participant at each testing session.
Change of Maximal Isometric Strength
Knee extensor (quadriceps) and ankle plantar flexors (gastrocnemius and soleus) strength will be measured using an isokinetic dynamometer. Maximum knee extensor force will be analyzed based on the maximum force produced over three attempts.
Change of Torque vs Speed Production
Torque vs speed production will be using an isokinetic dynamometer. Maximum rate of torque production will be calculated based on the highest rate measured over three attempts.
Change of Modified Spinal Cord Injury Spasticity Evaluation Tool (modified SCI-SET)
The modified SCI-SET is a subjective measure used to assess the effects of spasticity on daily life in people with SCI. It requires participants to recall their past 7 days when rating the impact of spasticity. The scale uses a range of -2 (very problematic) to +1 (helpful).
Full Information
NCT ID
NCT05429736
First Posted
May 2, 2022
Last Updated
November 18, 2022
Sponsor
Shepherd Center, Atlanta GA
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
1. Study Identification
Unique Protocol Identification Number
NCT05429736
Brief Title
Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
Official Title
SCIMS Site Specific Project: Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shepherd Center, Atlanta GA
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive spinal stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training (MST) with transcutaneous spinal stimulation (TSS) may further enhance the restoration of function in persons with SCI. Therefore, the purpose of this study is to determine if moderate-intensity, MST can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive TSS will result in greater improvements in function compared to training alone.
Detailed Description
Individuals with SCI will be asked to participate in this study over a four-week period. During the first 2 weeks (wash-in phase), individuals will participate in 6 aerobic and exercise training sessions as part of either an existing outpatient clinical program or by completing a personalized exercise plan. During the intervention phase (last 2 weeks), participants will be randomized to complete 6 training sessions of: 1) motor skill training combined with TSS (MST+TSS group), or 2) motor skill training combined with shamTSS (MST+shamTSS), or 3) cyclic aerobic exercise combined with TSS (CAX+TSS). All participants will complete 3 testing sessions: baseline testing 1 (prior the wash-in phase), testing 2 (after the completion of the wash-in phase and prior the intervention phase), and testing 3 (after the completion of the intervention phase) to assess their walking ability, balance, strength, and spasticity. During the intervention phase and to monitor within-session changes, participants will also complete a short version of walking function and balance assessments prior to and after each training session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incomplete Spinal Cord Injury, Spasticity, Muscle
Keywords
spinal, cord, incomplete, motor, skill, training, transcutaneous, stimulation, TSS, tSCS, electrophysiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MST + TSS
Arm Type
Experimental
Arm Description
Individuals will participate in 6 training sessions of MST combined with TSS.
Arm Title
MST + ShamTSS
Arm Type
Sham Comparator
Arm Description
Individuals will participate in 6 training sessions of MST while receiving shamTSS.
Arm Title
CAX + TSS
Arm Type
Active Comparator
Arm Description
Individuals will participate in 6 training sessions of CAX while receiving TSS
Intervention Type
Behavioral
Intervention Name(s)
Motor Skill Training (MST)
Intervention Description
During MST participants will perform a series of 6 motor skill exercises designed to challenge balance, lower extremity coordination, agility, and speed. Five of these activities will be performed while standing to promote upright control and one activity will be performed while seated (alternating toe-tapping) to provide opportunity for active recovery. Participants will perform each exercise for one minute each, until 4 cycles of the circuit have been completed (approximately 45 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). During MST, participants will wear a chest-worn heart rate monitor to ensure that the optimal HRR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Spinal Stimulation (TSS)
Other Intervention Name(s)
tSCS
Intervention Description
TSS will be delivered using a commercially available neuromuscular electrical stimulator. The active electrode will be positioned directly over the spine at the T11/T12 spinous interspace, and the reference electrode will be positioned over the umbilicus. Stimulation intensity will be gradually increased until paresthesia of the lower legs and feet is achieved or to the highest level each participant can tolerate. Stimulation will be delivered for a total duration of 30 min after paresthesia/ maximum tolerability is reached.
Intervention Type
Behavioral
Intervention Name(s)
Cyclic Aerobic Exercise (CAX)
Intervention Description
Participants will complete 35 minutes of seated elliptical exercise (5min warm up + 30 min of training) and will be asked to maintain a constant step rate for the duration of the intervention. This training may take up to 45 minutes if rest breaks are necessary. During CAX, participants will wear a chest-worn heart rate monitor to ensure that a HRR range of 40-59% is maintained. Resistance level will be adjusted to ensure the optimal target heart rate is achieved.
Primary Outcome Measure Information:
Title
Change in 10 Meter Walk Test
Description
Walking speed (as determined by the 10MWT) is the primary outcome measure for assessing walking function. Participants will complete 3 10MWT trials at each testing session, separated by 2 minutes of seated rest. The average walking speed of the 3 walks will be calculated and used in the analyses.
Time Frame
Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Secondary Outcome Measure Information:
Title
Change of Spatiotemporal Gait Characteristic (Cadence)
Description
Gait quality will be assessed from spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] of the weaker and stronger limbs, and step length symmetry) collected via instrumented walkway as participants completed three, 10MWT trials at each testing session. The average cadence across three walks will be used in the analysis.
Time Frame
Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Title
Change of Spatiotemporal Gait Characteristic (Stride Length - Both Lower Extremities)
Description
Gait quality will be assessed from spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] of the weaker and stronger limbs, and step length symmetry) collected via instrumented walkway as participants completed three, 10MWT trials at each testing session. The average stride length across three walks will be used in the analysis.
Time Frame
Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Title
Change of Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)
Description
Gait quality will be assessed from spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] of the weaker and stronger limbs, and step length symmetry) collected via instrumented walkway as participants completed three, 10MWT trials at each testing session. The average step length for each leg across three walks will be used to compute the symmetry index (%).
Time Frame
Testing 1(Day 1), Testing 2 (Day 12), Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Title
Change of Berg Balance Scale
Description
Balance will be measured using the BBS. The BBS total score will be calculated for each participant at each testing session. The total range of scores for the BBS equals 0-56, with higher scores from baseline indicating greater balance performance and lower scores from baseline indicating worsened balance performance. A subset of the BBS will be assess before and after each training session.
Time Frame
Testing 1 (Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Title
Change of Falls Efficacy Scale-International Version (FES-I)
Description
The FES-I total score will be calculated for each participant at each testing session to measure fear of falling. The total range of scores for the FES-I equals 16-64, with lower scores indicating decreased fear of falling.
Time Frame
Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Title
Change of Spinal Cord Assessment Tool for Spastic Reflexes
Description
The SCATS will be used to assess spasticity. The total range of scores possible for the SCATS is 0-18, with a total score of 0 indicating no lower limb spasticity and higher total scores indicating greater spasticity severity.
Time Frame
Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Title
Change of Modified 5-Times Sit-to-Stand
Description
The modified 5-times sit-to-stand test will be used as a measure of functional lower extremity strength. The average time to complete the test will be calculated at each testing session.
Time Frame
Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Title
Change of 2 Minute Walk Test
Description
Functional walking capacity will be measured based on the 2MWT distance. Total distance walked in 2-minutes will be recorded for each participant at each testing session.
Time Frame
Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Title
Change of Maximal Isometric Strength
Description
Knee extensor (quadriceps) and ankle plantar flexors (gastrocnemius and soleus) strength will be measured using an isokinetic dynamometer. Maximum knee extensor force will be analyzed based on the maximum force produced over three attempts.
Time Frame
Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Title
Change of Torque vs Speed Production
Description
Torque vs speed production will be using an isokinetic dynamometer. Maximum rate of torque production will be calculated based on the highest rate measured over three attempts.
Time Frame
Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Title
Change of Modified Spinal Cord Injury Spasticity Evaluation Tool (modified SCI-SET)
Description
The modified SCI-SET is a subjective measure used to assess the effects of spasticity on daily life in people with SCI. It requires participants to recall their past 7 days when rating the impact of spasticity. The scale uses a range of -2 (very problematic) to +1 (helpful).
Time Frame
Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be 18-70 years of age
Have a spinal cord injury (neurological level C3-T12) that occurred ≥3 months (sub-acute to chronic) prior to enrollment
Have ISNCSCI severity classification C or D
Able to stand for at least 5 minutes (with or without the aid of an assistive device)
Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device)
Able to rise from sit to stand with moderate assistance from one person
Use of prescription medication(s) for control of spasticity if the dosage has not changed in the last 2 weeks and you notify the study staff if your medication(s) change during study participation
Ability and willingness to consent and authorize use of personal health information
Ability to follow multiple instructions and communicate pain or discomfort
Exclusion Criteria:
Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord
Injuries below the neurological spinal level of T12
Pregnant, or if you have reason to believe you are or may become pregnant due to unknown risks to the fetus associated with TSS
History of cardiovascular irregularities
Presence of orthopedic conditions that would adversely affect participation in exercise
Implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g., baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator, diaphragmatic pacemaker)
Any cuts or sensitivity of the skin near the level of stimulation
Active cancer or history of cancer
Inability and unwillingness to consent and authorize use of personal health information
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles J Creech, DPT
Phone
678-877-9572
Email
jacob.creech@shepherd.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Evans, MHS
Email
Nicholas.Evans@shepherd.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edelle C Field-Fote, PT, PhD
Organizational Affiliation
Shepherd Center, Atlanta GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edelle C Field-Fote, PT, PhD
Phone
404-274-6040
Email
edelle.field-fote@shepherd.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
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