Improve Dynamic Lateral Balance of Humans With SCI

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: robotic training; Device: spinal cord electrical stimulation; Device: treadmill

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weena Dee, PT; Phone Number: 312-2384824; Email: wdee@ric.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Abilitylab
      • Contact: Weena Dee, PT; Phone Number: 312-238-7503; Email: wdee@sralab.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: robotic training & stimulation; Device: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks.	Device: robotic training; robotic training by applying pelvis force perturbation; Device: spinal cord electrical stimulation; Applying direct current electrical stimulation on spinal cord; Device: treadmill; conventional treadmill training only
Active Comparator: robotic training & sham; Device: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks.	Device: robotic training; robotic training by applying pelvis force perturbation; Device: treadmill; conventional treadmill training only
Placebo Comparator: treadmill only; Device: treadmill Conventional treadmill training only, three time a week for 6 weeks.	Device: treadmill; conventional treadmill training only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in overground gait speed from baseline	gait speed	post 6 weeks of training and 8 weeks after the end of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in balance (BBS score) from baseline	Berg Balance Score	post 6 weeks of training and 8 weeks after the end of training
Changes in dynamic gait index from baseline	Dynamic Gait Index	post 6 weeks of training and 8 weeks after the end of training
Changes in 6 minutes walking distance from baseline	Walking distance in 6 minutes	post 6 weeks of training and 8 weeks after the end of training

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Investigators: Principal Investigator: Ming Wu, PhD, Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimated): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: R01HD083314 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No