NCT02991248

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1.9 years until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

6.7 years

First QC Date

May 26, 2016

Last Update Submit

May 28, 2025

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Changes in overground gait speed from baseline

    gait speed

    post 6 weeks of training and 8 weeks after the end of training

Secondary Outcomes (3)

  • Changes in balance (BBS score) from baseline

    post 6 weeks of training and 8 weeks after the end of training

  • Changes in dynamic gait index from baseline

    post 6 weeks of training and 8 weeks after the end of training

  • Changes in 6 minutes walking distance from baseline

    post 6 weeks of training and 8 weeks after the end of training

Study Arms (3)

robotic training & stimulation

EXPERIMENTAL

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

Device: robotic trainingDevice: spinal cord electrical stimulationDevice: treadmill

robotic training & sham

ACTIVE COMPARATOR

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

Device: robotic trainingDevice: treadmill

treadmill only

PLACEBO COMPARATOR

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

Device: treadmill

Interventions

robotic trainingDEVICE

robotic training by applying pelvis force perturbation

robotic training & shamrobotic training & stimulation
spinal cord electrical stimulationDEVICE

Applying direct current electrical stimulation on spinal cord

robotic training & stimulation
treadmillDEVICE

conventional treadmill training only

robotic training & shamrobotic training & stimulationtreadmill only

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abilitylab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Ming Wu, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weena Dee, PT

CONTACT

312-2384824wdee@ric.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2016

First Posted

December 13, 2016

Study Start

November 1, 2018

Primary Completion

July 30, 2025

Study Completion

December 30, 2025

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Locations

US(1)