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Improve Dynamic Lateral Balance of Humans With SCI

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
robotic training
spinal cord electrical stimulation
treadmill
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AbilitylabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

robotic training & stimulation

robotic training & sham

treadmill only

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Changes in overground gait speed from baseline
gait speed

Secondary Outcome Measures

Changes in balance (BBS score) from baseline
Berg Balance Score
Changes in dynamic gait index from baseline
Dynamic Gait Index
Changes in 6 minutes walking distance from baseline
Walking distance in 6 minutes

Full Information

First Posted
May 26, 2016
Last Updated
March 10, 2023
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT02991248
Brief Title
Improve Dynamic Lateral Balance of Humans With SCI
Official Title
Improve Dynamic Lateral Balance of Humans With SCI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
robotic training & stimulation
Arm Type
Experimental
Arm Description
Device: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks.
Arm Title
robotic training & sham
Arm Type
Active Comparator
Arm Description
Device: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks.
Arm Title
treadmill only
Arm Type
Placebo Comparator
Arm Description
Device: treadmill Conventional treadmill training only, three time a week for 6 weeks.
Intervention Type
Device
Intervention Name(s)
robotic training
Intervention Description
robotic training by applying pelvis force perturbation
Intervention Type
Device
Intervention Name(s)
spinal cord electrical stimulation
Intervention Description
Applying direct current electrical stimulation on spinal cord
Intervention Type
Device
Intervention Name(s)
treadmill
Intervention Description
conventional treadmill training only
Primary Outcome Measure Information:
Title
Changes in overground gait speed from baseline
Description
gait speed
Time Frame
post 6 weeks of training and 8 weeks after the end of training
Secondary Outcome Measure Information:
Title
Changes in balance (BBS score) from baseline
Description
Berg Balance Score
Time Frame
post 6 weeks of training and 8 weeks after the end of training
Title
Changes in dynamic gait index from baseline
Description
Dynamic Gait Index
Time Frame
post 6 weeks of training and 8 weeks after the end of training
Title
Changes in 6 minutes walking distance from baseline
Description
Walking distance in 6 minutes
Time Frame
post 6 weeks of training and 8 weeks after the end of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 18 and 65 years; medically stable with medical clearance to participate; level of the SCI lesion between C4-T10; passive range of motion of the legs within functional limits of ambulation; ability to walk on a treadmill for more than 20 minutes with partial body weight support as needed and short sitting/standing breaks; ability to ambulate without orthotics or with orthotics that do not cross the knee for more than 10 meters Exclusion Criteria: 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); history of recurrent fractures and/or known orthopedic injury to the lower extremities; Botox injection within 6 months of starting the study, and current receiving physical therapy treatment; have metallic implantation in the spinal region underneath where electrodes may be placed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weena Dee, PT
Phone
312-2384824
Email
wdee@ric.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Wu, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abilitylab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weena Dee, PT
Phone
312-238-7503
Email
wdee@sralab.org

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Improve Dynamic Lateral Balance of Humans With SCI

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