NCT05337982

Brief Summary

The investigators are studying a new rehabilitation treatment for individuals trying to recover walking after spinal cord injury (SCI). The investigators will test conditions in the blood and spinal fluid to determine the best time to start this new training program. This will include checking for certain features called biomarkers by testing participants' spinal fluid and blood and compare these features to individuals without SCI. These features will help investigators determine when to start the new training program, either right away or waiting for 3 months. The new training program uses walking downhill on a slight slope on a treadmill while muscles that are not working normally are stimulated to contract using low levels of electricity. Adding this stimulation will allow people to practice walking and other skills even though full muscle control has not recovered. This new program will be in addition to any other rehabilitation therapy and will not replace standard rehabilitation. The hope is to see if downhill training with muscle stimulation, when delivered at the most ideal time, will improve trunk and leg movement, walking, and overall function. This recovery of movement and function will be compared to people with SCI receiving standard rehabilitation alone. Certain regions of the brain and spinal cord will also be studied using MRI scans to determine if these are affected by the training and compare to individuals without SCI. The total length of the study for SCI participants will be up to 16 weeks if in the standard of care group and up to 33 weeks if in the trained group. Healthy control participants will be involved for 1-2 visits.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

Study Progress86%
May 2022Dec 2026

First Submitted

Initial submission to the registry

January 5, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

4.6 years

First QC Date

January 5, 2022

Last Update Submit

December 16, 2025

Conditions

HealthySpinal Cord Injuries

Keywords

Spinal Cord InjurySCIBiomarkersMRILocomotor TrainingDownhillNeuromodulationElectrical StimulationCSFRehabilitationPhysical TherapyEccentricTreadmillblood draw

Outcome Measures

Primary Outcomes (9)

  • Change from baseline in electromyography of eccentric acting muscles

    Muscle activation during weight acceptance while walking on a treadmill

    12 weeks

  • Change from baseline in kinetics during weight acceptance

    Peak magnitude of loading response as measured by the peak magnitude of power absorption during the weight acceptance phase of walking on a treadmill

    12 weeks

  • Change from baseline in kinematics during weight acceptance: hip range of motion

    Range of motion of the hip joint during walking on a treadmill

    12 weeks

  • Change from baseline in kinematics during weight acceptance: knee range of motion

    Range of motion of the knee joint during walking on a treadmill

    12 weeks

  • Change from baseline in kinematics during weight acceptance: ankle range of motion

    Range of motion of the ankle joint during walking on a treadmill

    12 weeks

  • Change from baseline in kinematics during weight acceptance: hip acceleration

    Acceleration of the hip joint during walking on a treadmill

    12 weeks

  • Change from baseline in kinematics during weight acceptance: knee acceleration

    Acceleration of the knee joint during walking on a treadmill

    12 weeks

  • Change from baseline in kinematics during weight acceptance: ankle acceleration

    Acceleration of the ankle joint during walking on a treadmill

    12 weeks

  • Change from baseline in myelination in brain and spinal cord measured by Magnetic Resonance Imaging (MRI)

    Myelin spared pre and post intervention in the motor areas of the brain and cervical spinal cord compared to healthy controls

    12 weeks

Secondary Outcomes (32)

  • Change from baseline in ASIA Impairment Scale (AIS)

    12 weeks

  • Change from 12 weeks to 16 weeks in American Spinal Injury Association (ASIA) Impairment Scale (AIS)

    16 weeks

  • Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores

    12 weeks

  • Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores

    16 weeks

  • Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): sensory scores

    12 weeks

  • +27 more secondary outcomes

Study Arms (4)

SCI Go

EXPERIMENTAL

Participants with SCI randomized to the experimental group that have biomarkers that indicate low levels of inflammation will start immediately.

Other: Downhill Eccentric Treadmill Training with Electrical Stimulation

SCI No Go

EXPERIMENTAL

Participants with SCI randomized to the experimental group that have biomarkers that indicate high levels of inflammation will have a delayed start of 3 months.

Other: Downhill Eccentric Treadmill Training with Electrical Stimulation

SCI SOC

NO INTERVENTION

Participants with SCI randomized to the standard of care (SOC) group will continue with regular therapy.

Healthy Control

NO INTERVENTION

Healthy controls will provide biomarker and/or myelin (MRI) data

Interventions

Downhill Eccentric Treadmill Training with Electrical StimulationOTHER

Participants will walk on a treadmill with a downward incline with support from a harness and assistance from trainers as needed. Participants will also simultaneously receive stimulation to their muscles including their trunk and legs. Each session will include 20 minutes of walking divided into 5 minute bouts with 5 minute rest breaks in between for 3 sessions per week for 12 weeks.

SCI GoSCI No Go

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SCI participants WITHIN 1-5 MONTHS OF THEIR INJURY:
  • Discharged from inpatient rehabilitation;
  • AIS A-D at neurologic level C1-T10;
  • years old.
  • Healthy controls:
  • Adults 18-85 years old;
  • no recent major musculoskeletal injury;
  • no recent surgery.

You may not qualify if:

  • SCI participants:
  • Use of botox in the past 3 months that reduces skeletal muscle function;
  • other neurologic conditions (i.e. brain injury, stroke, HIV);
  • current cancer diagnosis;
  • active deep vein thrombosis and anti-coagulation therapy;
  • skin wounds in regions that interfere with harness, stimulation pads or hand placement needed for training.
  • pregnancy;
  • ventilator-dependence;
  • cognitive conditions that preclude providing informed consent.
  • Implanted medical devices that are contraindicated for electrical stimulation or MRI \*(If SCI participants have conditions contraindicated for MRI they may still participate in the remainder of study activities without myelin status as an outcome measure. SCI is a rare condition therefore this is necessary in order to achieve the required sample size.)
  • Healthy controls:
  • Implanted medical devices that are contraindicated for MRI (MRI participants only);
  • neurologic conditions (i.e. brain injury, stroke, HIV);
  • current cancer diagnosis;
  • clotting disorders requiring anti-coagulation therapy;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of British Columbia

Vancouver, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • D. Michele Basso, EdD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Basso, EdD, PT

CONTACT

614-814-1404michele.basso@osumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants' primary physical therapist who will also be the outcomes assessor for clinical outcomes will be masked. Two collaborators will be masked when assessing outcomes including myelin plasticity and biomechanical outcomes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2022

First Posted

April 20, 2022

Study Start

May 17, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

CA(1)US(1)