Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity

• ClinicalTrials.gov Identifier: NCT05429736
• Recruitment Status: Recruiting
• First Posted: June 23, 2022
• Last Update Posted: November 23, 2022
• Sponsor: Shepherd Center, Atlanta GA
• Collaborator: National Institute on Disability, Independent Living, and Rehabilitation Research
• Information provided by (Responsible Party): Edelle Field-Fote, PT, PhD, Shepherd Center, Atlanta GA

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.

Condition or disease	Intervention/treatment	Phase
Incomplete Spinal Cord Injury; Spasticity, Muscle	Behavioral: Motor Skill Training (MST); Device: Transcutaneous Spinal Stimulation (TSS); Behavioral: Cyclic Aerobic Exercise (CAX)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: SCIMS Site Specific Project: Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
• Actual Study Start Date: March 1, 2022
• Estimated Primary Completion Date: March 2026
• Estimated Study Completion Date: March 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: MST + TSS; Individuals will participate in 6 training sessions of MST combined with TSS.	Behavioral: Motor Skill Training (MST); 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.; Device: Transcutaneous Spinal Stimulation (TSS); 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.; Other Name: tSCS
Sham Comparator: MST + ShamTSS; Individuals will participate in 6 training sessions of MST while receiving shamTSS.	Behavioral: Motor Skill Training (MST); 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.
Active Comparator: CAX + TSS; Individuals will participate in 6 training sessions of CAX while receiving TSS	Device: Transcutaneous Spinal Stimulation (TSS); 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.; Other Name: tSCS; Behavioral: Cyclic Aerobic Exercise (CAX); 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.

Outcome Measures

Primary Outcome Measures :

1. Change in 10 Meter Walk Test [ 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) ]
   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 :

1. Change of Spatiotemporal Gait Characteristic (Cadence) [ 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) ]
   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.
2. Change of Spatiotemporal Gait Characteristic (Stride Length - Both Lower Extremities) [ 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) ]
   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.
3. Change of Spatiotemporal Gait Characteristic (Step Length Symmetry - 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) ]
   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 (%).
4. Change of Berg Balance Scale [ 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) ]
   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.
5. Change of Falls Efficacy Scale-International Version (FES-I) [ Time Frame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27) ]
   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.
6. Change of Spinal Cord Assessment Tool for Spastic Reflexes [ Time Frame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27) ]
   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.
7. Change of Modified 5-Times Sit-to-Stand [ Time Frame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27) ]
   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.
8. Change of 2 Minute Walk Test [ Time Frame: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27) ]
   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.
9. Change of Maximal Isometric Strength [ Time Frame: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27) ]
   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.
10. Change of Torque vs Speed Production [ Time Frame: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27) ]
    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.
11. Change of Modified Spinal Cord Injury Spasticity Evaluation Tool (modified SCI-SET) [ Time Frame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27) ]
    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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Charles J Creech, DPT; 678-877-9572; jacob.creech@shepherd.org

Contact: Nicholas Evans, MHS; Nicholas.Evans@shepherd.org

Locations

United States, Georgia

Shepherd Center; Recruiting

Atlanta, Georgia, United States, 30309

Contact: Edelle C Field-Fote, PT, PhD 404-274-6040 edelle.field-fote@shepherd.org

Sponsors and Collaborators

Shepherd Center, Atlanta GA

National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

• Principal Investigator: Edelle C Field-Fote, PT, PhD; Shepherd Center, Atlanta GA

More Information

• Responsible Party: Edelle Field-Fote, PT, PhD, Principal Investigator, Shepherd Center, Atlanta GA
• ClinicalTrials.gov Identifier: NCT05429736
• Other Study ID Numbers: 1842303
• First Posted: June 23, 2022
• Last Update Posted: November 23, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Edelle Field-Fote, PT, PhD, Shepherd Center, Atlanta GA:

spinal; cord; incomplete; motor; skill; training; transcutaneous; stimulation; TSS; tSCS; electrophysiology

Additional relevant MeSH terms:

Muscle Spasticity; Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations