Recruiting

TLS & EAW

Sponsor:

Kessler Foundation

Code:

NCT03096197

Conditions

Spinal Cord Injury

Ambulation Difficulty

Muscle Spasticity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Exoskeleton-Assisted Walking

Transcutaneous Lumbosacral Stimulation (TLS)

Study Details

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.

Conditions

Spinal Cord Injury

Ambulation Difficulty

Muscle Spasticity

Study ID

NCT03096197

Start date

Mar 30, 2017

Status verified date

Dec, 2025

Completion date

Sep, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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;

Exclusion Criteria:

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: EAW + TLS

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).

experimental: EAW without TLS

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 .

Interventions

Exoskeleton-Assisted Walking

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.

Transcutaneous Lumbosacral Stimulation (TLS)

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.

Primary outcome measure

  • Percentage change 6-minute walk test (6MWT) [ Time Frame: 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) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Gail F Forrest, PhD

973-324-3518gforrest@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Gail F Forrest, Ph.D

973 324 3518gforrest@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Jan 14, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2026-01-14.