Improve dynamic lateral balance during walking after spinal cord injury

Improve Dynamic Lateral Balance of Humans With SCI

This trial will test whether adding pelvis perturbation training with transcutaneous spinal direct current stimulation (tsDCS) helps adults with spinal cord injury improve dynamic balance and walking compared with sham stimulation or treadmill-only training.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shirley Ryan AbilityLab (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT02991248 on ClinicalTrials.gov

What this trial studies

Participants with spinal cord injury who can walk on a treadmill with or without partial body-weight support will be randomized to one of three groups: pelvis perturbation training paired with active tsDCS, pelvis perturbation training paired with sham stimulation, or treadmill training only. Pelvis perturbations are delivered during treadmill walking to increase lateral balance muscle activation, while tsDCS is applied noninvasively over the spinal cord to potentially boost spinal circuit excitability. The protocol uses repeated training sessions to promote use-dependent plasticity and measures changes in dynamic balance and locomotor function over time. Safety screening excludes participants with unstable skin, certain implants, severe cardiopulmonary disease, recent Botox, or other conditions that would interfere with participation.

Who should consider this trial

Good fit: Adults 18–65 years old with a cervical to upper thoracic SCI (C4–T10) who are medically stable and can walk on a treadmill for more than 20 minutes with or without partial body-weight support are the best candidates.

Not a fit: People who cannot ambulate on a treadmill, have unhealed wounds or infections, metallic spinal implants at the stimulation site, severe cardiopulmonary disease, recent Botox injections, or other disqualifying comorbidities are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could improve lateral balance during walking, reduce fall risk, and increase walking independence for people with SCI.

How similar studies have performed: Previous pilot and animal studies suggest noninvasive spinal stimulation and perturbation-based balance training can improve locomotor responses, but combining pelvis perturbation with tsDCS in humans with SCI is relatively novel and not yet widely proven.

Eligibility criteria

Inclusion Criteria:

1. age between 18 and 65 years;
2. medically stable with medical clearance to participate;
3. level of the SCI lesion between C4-T10;
4. passive range of motion of the legs within functional limits of ambulation;
5. ability to walk on a treadmill for more than 20 minutes with partial body weight support as needed and short sitting/standing breaks;
6. ability to ambulate without orthotics or with orthotics that do not cross the knee for more than 10 meters

Exclusion Criteria:

1. the presence of unhealed decubiti, existing infection, severe cardiovascular and pulmonary disease, concomitant central or peripheral neurological injury (e.g. traumatic head injury or peripheral nerve damage in lower limbs);
2. history of recurrent fractures and/or known orthopedic injury to the lower extremities;
3. Botox injection within 6 months of starting the study, and current receiving physical therapy treatment;
4. have metallic implantation in the spinal region underneath where electrodes may be placed.

Where this trial is running

Chicago, Illinois

• Abilitylab — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Ming Wu, PhD — Shirley Ryan AbilityLab
• Study coordinator: Weena Dee, PT

Conditions Spinal Cord Injury