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Improve Dynamic Lateral Balance of Humans With SCI

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ClinicalTrials.gov Identifier: NCT02991248
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Ming Wu, Shirley Ryan AbilityLab

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: robotic training Device: spinal cord electrical stimulation Device: treadmill Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improve Dynamic Lateral Balance of Humans With SCI
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : September 30, 2023
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in overground gait speed from baseline [ Time Frame: post 6 weeks of training and 8 weeks after the end of training ]
    gait speed


Secondary Outcome Measures :
  1. Changes in balance (BBS score) from baseline [ Time Frame: post 6 weeks of training and 8 weeks after the end of training ]
    Berg Balance Score

  2. Changes in dynamic gait index from baseline [ Time Frame: post 6 weeks of training and 8 weeks after the end of training ]
    Dynamic Gait Index

  3. Changes in 6 minutes walking distance from baseline [ Time Frame: post 6 weeks of training and 8 weeks after the end of training ]
    Walking distance in 6 minutes


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991248


Contacts
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Contact: Weena Dee, PT 312-2384824 wdee@ric.org

Locations
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United States, Illinois
Abilitylab Recruiting
Chicago, Illinois, United States, 60611
Contact: Weena Dee, PT    312-238-7503    wdee@sralab.org   
Sponsors and Collaborators
Shirley Ryan AbilityLab
Investigators
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Principal Investigator: Ming Wu, PhD Shirley Ryan AbilityLab
More Information
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Responsible Party: Ming Wu, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT02991248    
Other Study ID Numbers: R01HD083314 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries