NCT03096197

Brief Summary

The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
40mo left

Started Mar 2017

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

Study Progress73%
Mar 2017Sep 2029

First Submitted

Initial submission to the registry

June 12, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

January 14, 2026

Status Verified

December 1, 2025

Enrollment Period

11.7 years

First QC Date

June 12, 2016

Last Update Submit

January 12, 2026

Conditions

Spinal Cord InjuryAmbulation DifficultyMuscle Spasticity

Keywords

Spinal Cord injury (SCI)Transcutaneous lumbosacral stimulation (TLS)Exoskeleton-Assisted Walking (EAW)

Outcome Measures

Primary Outcomes (2)

  • Percentage change 6-minute walk test (6MWT)

    Participants undergoing EAW+TLS intervention will walk significantly further than those receiving EAW alone.

    Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions.

  • Percentage change 10 meter walk test (10MWT)

    Participants undergoing EAW+TLS intervention will walk significantly faster than those receiving EAW alone training.

    Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions.

Secondary Outcomes (2)

  • Percentage change in scores on Berg Balance scale (BERG)

    Measurements will be performed during the 28 weeks of training intervention after baseline. Training intervention is 28 weeks, 80 sessions total. Measurements will be performed after 20, 40, 60 and 80 sessions.

  • Absolute change in the International Standards Examination

    Baseline and post intervention

Other Outcomes (3)

  • percent change in ariel mineral bone density.

    Baseline and immediately post intervention.

  • percent change in volume metric and bone mineral density.

    Baseline and immediately post intervention.

  • percent change in bone strength and bone stiffness.

    Baseline and immediately post intervention.

Study Arms (2)

EAW + TLS

EXPERIMENTAL

The EAW+TLS training group will receive 60 minutes of exoskeleton-assisted walking overground per session, for a total of 80 sessions (3x/week, 28 wks.) with simultaneous transcutaneous lumbosacral stimulation (TLS) intervention followed by 15 minutes of over ground training without the exoskeleton. component is added to the exoskeleton assisted walking component in this group. TLS will involve placing self-adhesive stimulating electrodes bilaterally over the T11/T12 lumbar region. Correct placement will be confirmed by the elicitation of posterior root muscle reflexes in the lower limb muscles. A constant-voltage stimulator (RT 50 Sage stimulator) will deliver pulses of 2 ms width. TLS will be applied while the participant walks in the Exo-skeleton-assisted walking (EAW).

Device: Exoskeleton-Assisted WalkingDevice: Transcutaneous Lumbosacral Stimulation (TLS)

EAW without TLS

EXPERIMENTAL

EAW, exoskeleton-assisted walking, an activity based therapy is a training which involves using the same exoskeleton device for all the participants. Each participant will undergo, 60 minutes of EAW as above. Each participant will undergo a stand evaluation and be instructed in proper use of the device. During the initial 3 sessions of training, the exoskeleton device will be tethered to an overhead pulley system during training to allow subjects to safely adapt to trunk, balance gait activities while walking in the exoskeleton. EAW overground walking will follow each training session with the 6-minute walk test, 10 meter walk test .

Device: Exoskeleton-Assisted Walking

Interventions

Exoskeleton-Assisted WalkingDEVICE

Exoskeleton-Assisted Walking (EAW) is an activity based therapy. Each group will receive 60 minutes of robotic intervention training per session, for a total of 80 sessions.

EAW + TLSEAW without TLS
Transcutaneous Lumbosacral Stimulation (TLS)DEVICE

EAW+TLS. This group will receive 60 minutes of exoskeleton assisted overground walking with simultaneous Transcutaneous Lumbosacral Stimulation (TLS) followed by 15 minutes of overground training without exoskeleton.

Also known as: RT 50 Sage Stimulator
EAW + TLS

Eligibility Criteria

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

You may qualify if:

  • In order to be eligible to participate in this study a participant must:
  • be a non-walker with an SCI greater than 6 years post injury;
  • have a lower extremity motor score greater or equal to 16 as measured by the International Standards for Neurological Classification of SCI exam;
  • be between the ages of 18-65 years old;
  • have a spinal cord injury at a neurological level of injury as determined by study staff between C5-T-10;
  • be wheelchair reliant 100% of the time;
  • have knee bone mineral density great than .5755gm/cm2 as determined by study staff;

You may not qualify if:

  • have a history of broken or fractured bones.
  • have a history of bone trauma or bone disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

Related Publications (1)

  • Cirnigliaro CM, Kuo W, Forrest GF, Spungen AM, Parrott JS, Cardozo CP, Pal S, Bauman WA. Exoskeletal-assisted walking combined with transcutaneous spinal cord stimulation to improve bone health in persons with spinal cord injury: study protocol for a prospective randomised controlled trial. BMJ Open. 2024 Sep 17;14(9):e086062. doi: 10.1136/bmjopen-2024-086062.

    PMID: 39289024DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesMobility LimitationMuscle Spasticity

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic Manifestations

Study Officials

  • Gail F. Forrest, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail F Forrest, PhD

CONTACT

973-324-3518gforrest@kesslerfoundation.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director of HPER

Study Record Dates

First Submitted

June 12, 2016

First Posted

March 30, 2017

Study Start

March 30, 2017

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

January 14, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)