Spinal Cord InjuryNCT02991248
Improve Dynamic Lateral Balance of Humans With SCI
A study testing robotic training, spinal cord electrical stimulation and treadmill in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- robotic training, spinal cord electrical stimulation and treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abilitylab
Chicago, Illinois, 60611
Weena Dee, PT, 312-238-7503, wdee@sralab.org
About this study
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.
Read the 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
- Being tested
- robotic training, spinal cord electrical stimulation, treadmill
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic trainingDevice
robotic training by applying pelvis force perturbation
spinal cord electrical stimulationDevice
Applying direct current electrical stimulation on spinal cord
treadmillDevice
conventional treadmill training only
| Study group | Role | What they receive |
|---|---|---|
| robotic training & stimulation | Experimental | Device: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks. Receives: Device: robotic training; Device: spinal cord electrical stimulation; Device: treadmill |
| robotic training & sham | Active comparator | Device: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks. Receives: Device: robotic training; Device: treadmill |
| treadmill only | Placebo comparator | Device: treadmill Conventional treadmill training only, three time a week for 6 weeks. Receives: Device: treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in overground gait speed from baseline
gait speed
Measured: post 6 weeks of training and 8 weeks after the end of training
Secondary outcomes (3)
Changes in balance (BBS score) from baseline
Berg Balance Score
Measured: post 6 weeks of training and 8 weeks after the end of training
Changes in dynamic gait index from baseline
Dynamic Gait Index
Measured: 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
Measured: post 6 weeks of training and 8 weeks after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start1 Nov 2018
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wu, Shirley Ryan AbilityLab
- Investigators
- Ming Wu, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991248
- Sponsor's protocol ID
- R01HD083314
- Status last verified
- May 2025
- First submitted
- 26 May 2016
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve Dynamic Lateral Balance of Humans With SCI
- ClinicalTrials.gov ID
- NCT02991248
- Acronym / sponsor ID
- R01HD083314
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| robotic training & stimulation | Experimental | Device: robotic training, Device: spinal cord electrical stimulation, Device: treadmillDevice: robotic treadmill training paired with active spinal cord electrical stimulation, three times a week for 6 weeks. |
| robotic training & sham | Active comparator | Device: robotic training, Device: treadmillDevice: robotic training paired with sham spinal cord stimulation, three time a week for 6 weeks. |
| treadmill only | Placebo comparator | Device: treadmillDevice: treadmill Conventional treadmill training only, three time a week for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic trainingrobotic training by applying pelvis force perturbation | Device | robotic training & sham, robotic training & stimulation |
| spinal cord electrical stimulationApplying direct current electrical stimulation on spinal cord | Device | robotic training & stimulation |
| treadmillconventional treadmill training only | Device | robotic training & sham, robotic training & stimulation, treadmill only |
Primary outcome
Changes in overground gait speed from baseline
Time frame: post 6 weeks of training and 8 weeks after the end of training
gait speed
3 secondary outcomes
Changes in balance (BBS score) from baseline
Time frame: post 6 weeks of training and 8 weeks after the end of training
Changes in dynamic gait index from baseline
Time frame: post 6 weeks of training and 8 weeks after the end of training
Changes in 6 minutes walking distance from baseline
Time frame: post 6 weeks of training and 8 weeks after the end of training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming Wu, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic training, spinal cord electrical stimulation and treadmill in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weena Dee, PT (312-2384824, wdee@ric.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in overground gait speed from baseline (time frame: post 6 weeks of training and 8 weeks after the end of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.