The Effect of Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation on Bone Strength.

NCT07325149 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 1914010-2IK2 RD000484-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Immobilization following spinal cord injury (SCI) results in muscle and bone loss below the level of injury, which ultimately predisposes to fracture at several sites throughout the legs and can lead to several medical complications that can devastate quality of life. There is a scarcity of research that has successfully implemented rehabilitation and/or exercise training interventions to preserve the musculoskeletal system during the acute phase SCI, or possibly reverse the muscle and bone loss that has already occurred in chronic SCI. This study will compare the effect of exoskeleton-assisted walking (EAW) training combined with transcutaneous spinal cord stimulation (tSCS) (EAW + active tSCS), to that of EAW + sham tSCS, on measures of muscle and bone health in a cohort of chronically injured motor incomplete SCI. A successful outcome would expand treatment options to improve musculoskeletal health over the lifetime.

Conditions

Secondary Osteoporosis; Sarcopenia

Keywords

Spinal Cord Injury; Transcutaneous Spinal Cord Stimulation; Bone Mineral Density; Exoskeleton-Assisted Walking; Muscle Cross Sectional Area

Outcome Measures

Primary Outcomes (1)

• Muscle cross sectional area of the mid-thigh

  EAW + active tSCS will increase muscle cross sectional area of the mid-thigh more than EAW + sham tSCS.

  Obtained prior to starting the study at enrollment (baseline) and again after 9 months of participating in the study interventions.

Other Outcomes (3)

• Bone Strength at the Distal Femur and Proximal Tibia

  Obtained prior to starting the study at enrollment (baseline), after ~54 training sessions (4.5 months), with a final measurement completed after 9 months of the training interventions.

• Muscle and Bone Serum and Plasma Biomarker Time-Course Response

  Obtained prior to starting the study at enrollment (baseline), after ~54 training sessions (4.5 months), with a final measurement completed after 9 months of the training interventions.

• Seated and Supine Electromyography (EMG) assessments of Muscle Activation

  Obtained prior to starting the study at enrollment (baseline), after ~54 training sessions (4.5 months), with a final measurement completed after 9 months of the training interventions.

Study Arms (2)

Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS)

EXPERIMENTAL

The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.

Device: Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS)

Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS)

SHAM COMPARATOR

The EAW + sham tSCS group will receive simultaneous lumbosacral sham tSCS while simultaneously performing EAW. Participants in both groups will receive 60 minutes of EAW + sham tSCS overground training per session for a total of 108 sessions (3 X week for 36 weeks).

Device: Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS)

Interventions

Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS) DEVICE

The full electrical signal is delivered during lumbosacaral tSCS treatment while simultaneously performing EAW. Participants in both groups will receive 60 minutes of EAW + active tSCS overground training per session for a total of 108 sessions (3 X week for 36 weeks).

Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS)

Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS) DEVICE

The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.

Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Medical history and exam to ensure medical health, anthropometric compatibility for EAW, and to identify fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs.
• Between the ages of 21-60 years old
• Non-walkers with an SCI greater than 3 years post injury.
• As measured by a member of the study staff, participants who have a lower extremity motor score greater or equal to 16 on the INSCSCI exam with an impairment grade of C or D.
• Neurologic level of injury as determined by study staff between C5-T10 (completed at participant's screening).
• Capable of gripping Lofstrand crutches and/or a walker without assistance.
• Wheelchair reliant 100% of the time.
• Height is between 62 inches and 74 inches.
• Weight less than 220lbs.
• Anthropometric compatibility with the EAW device:
• Thigh length between 14 and 19 in (36 and 48 cm).
• Shank length between 17 and 22 in (43 and 55 cm).
• As determined by the study physician from the screening health exam, a history of fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs.
• Current bone disease diagnosis (e.g., osteomyelitis, hyperparathyroidism)
• As determined by the study physician from the screening DXA study, a T-score at the total hip \< -3.5 or aBMD of the knee (proximal tibia and/or distal femur) \< 0.60 g/cm2 from the DXA screen

Sponsors & Collaborators

• Bronx VA Medical Center: lead
• Kessler Foundation: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Publications (6)

• Totosy de Zepetnek JO, Craven BC, Giangregorio LM. An evaluation of the muscle-bone unit theory among individuals with chronic spinal cord injury. Spinal Cord. 2012 Feb;50(2):147-52. doi: 10.1038/sc.2011.99. Epub 2011 Sep 6.

  PMID: 21894164 RESULT

• Samejima S, Caskey CD, Inanici F, Shrivastav SR, Brighton LN, Pradarelli J, Martinez V, Steele KM, Saigal R, Moritz CT. Multisite Transcutaneous Spinal Stimulation for Walking and Autonomic Recovery in Motor-Incomplete Tetraplegia: A Single-Subject Design. Phys Ther. 2022 Jan 1;102(1):pzab228. doi: 10.1093/ptj/pzab228.

  PMID: 35076067 RESULT

• Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.

  PMID: 26205686 RESULT

• Gerasimenko YP, Lu DC, Modaber M, Zdunowski S, Gad P, Sayenko DG, Morikawa E, Haakana P, Ferguson AR, Roy RR, Edgerton VR. Noninvasive Reactivation of Motor Descending Control after Paralysis. J Neurotrauma. 2015 Dec 15;32(24):1968-80. doi: 10.1089/neu.2015.4008. Epub 2015 Aug 20.

  PMID: 26077679 RESULT

• Karelis AD, Carvalho LP, Castillo MJ, Gagnon DH, Aubertin-Leheudre M. Effect on body composition and bone mineral density of walking with a robotic exoskeleton in adults with chronic spinal cord injury. J Rehabil Med. 2017 Jan 19;49(1):84-87. doi: 10.2340/16501977-2173.

  PMID: 27973679 RESULT

• Shackleton C, Evans R, West S, Derman W, Albertus Y. Robotic Walking to Mitigate Bone Mineral Density Decline and Adverse Body Composition in Individuals With Incomplete Spinal Cord Injury: A Pilot Randomized Clinical Trial. Am J Phys Med Rehabil. 2022 Oct 1;101(10):931-936. doi: 10.1097/PHM.0000000000001937. Epub 2021 Dec 6.

  PMID: 34864766 RESULT

MeSH Terms

Conditions

Sarcopenia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Christopher P Cardozo, M.D.

  James J. Peters VA Medical Center

  STUDY DIRECTOR

Central Study Contacts

Christopher M Cirnigliaro, Ph.D.

CONTACT

570-242-5117; christopher.cirnigliaro@va.gov

Gail F Forrest, Ph.D.

CONTACT

609-558-2929; gforrest@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, Research Health Science Specialist

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 1, 2033
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)