Improve Dynamic Lateral Balance of Humans With SCI

NCT ID: NCT02991248

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2025-12-30

Brief Summary

This study is to test whether pelvis perturbation training paired with transcutaneous spinal direct current stimulation (tsDCS) will be effective in improving dynamic balance and locomotor function in humans with SCI. One group will receive pelvis perturbation training paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and one group will receive treadmill training only.

Detailed Description

A major goal of patients with spinal cord injury (SCI) is to regain walking ability, as limitations in mobility can affect most activities of daily living. In addition, patients with SCI may experience a higher incidence of falls due to impaired balance and gait. Dynamic balance control plays a crucial role during locomotion in human SCI. Thus, improved dynamic balance may facilitate locomotion in this population. Current balance training paradigms can be effective in improving balance during standing, but are less effective in improving dynamic balance during locomotion in humans with SCI. Thus, there is a need to develop new paradigms for improving dynamic balance and locomotor function in patients with SCI. The goal of this study is to test whether pelvis perturbation training paired with transcutaneous spinal direct current stimulation (tsDCS) will be effective in improving dynamic balance and locomotor function in humans with SCI. We postulate that providing a perturbation force to the pelvis during treadmill training will increase the activation of muscles used for maintaining lateral balance while walking. Further, repeated activation of particular sensorimotor pathways may reinforce circuits and synapses used for lateral balance control through a use-dependent neural plasticity mechanism. However, the excitability of spinal cord neural circuitries may be depressed due to the reduced descending drive signals from the upper level control center after SCI, which may reduce the efficacy of neuralplastic changes achieved following rehabilitation. The excitability of neural pathways is crucial for neural reorganization achieved following rehabilitation. Recently studies indicate that tsDCS may modulate the excitability of neural circuitries of the spinal cord in patients with SCI. Thus, we postulate that controlled pelvis perturbation training paired with tsDCS will be more effective than that paired with a sham in improving dynamic balance and locomotor function in humans with SCI. Results obtained from this study will lead to an innovative clinical therapy aimed at improving balance and walking function in humans with SCI. Improvements in balance and walking function may allow for increased participation in community-based ambulation and activities, and significantly improve quality of life in humans with SCI.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

robotic training & stimulation

Device: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks.

Group Type: EXPERIMENTAL

robotic training

Intervention Type: DEVICE

robotic training by applying pelvis force perturbation

spinal cord electrical stimulation

Intervention Type: DEVICE

Applying direct current electrical stimulation on spinal cord

treadmill

Intervention Type: DEVICE

conventional treadmill training only

robotic training & sham

Device: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks.

Group Type: ACTIVE_COMPARATOR

robotic training

Intervention Type: DEVICE

robotic training by applying pelvis force perturbation

treadmill

Intervention Type: DEVICE

conventional treadmill training only

treadmill only

Device: treadmill Conventional treadmill training only, three time a week for 6 weeks.

Group Type: PLACEBO_COMPARATOR

treadmill

Intervention Type: DEVICE

conventional treadmill training only

Interventions

robotic training

robotic training by applying pelvis force perturbation

Intervention Type: DEVICE

spinal cord electrical stimulation

Applying direct current electrical stimulation on spinal cord

Intervention Type: DEVICE

treadmill

conventional treadmill training only

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Ming Wu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Abilitylab

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Weena Dee, PT

Role: CONTACT

wdee@ric.org

312-2384824

Facility Contacts

Weena Dee, PT

Role: primary

wdee@sralab.org

312-238-7503

Other Identifiers

R01HD083314

Identifier Type: NIH

Identifier Source: org_study_id

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