NCT07325149Toborzás még nem indult
The Effect of Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation on Bone Strength.
Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 8.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 24 (tervezett)
- Első benyújtás
- 2025. dec. 18.
- Kezdés
- 2026. júl. 1.
- Elsődleges befejezés
- 2031. jún. 30.
- Fő szponzor
- Bronx VA Medical Center
- Betegségek
- Csontritkulás
- NCT-szám
- NCT07325149
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 24
- 2026. júl. 1. és az elsődleges befejezés (2031. jún. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- Body metal, including any of the following:
- metal fragments or pieces in eyes or any other part of body
- pacemakers or other implanted electrical devices
- aneurysm clips (metal clips on wall of a large artery)
- metallic prostheses (metal pins and heart valves)
- internal hearing aids (cochlear implants)
- permanent eyeliner
- shrapnel fragments
- piercing that cannot be removed
Egyéb
- Medically unsafe to receive an MRI scan.
- Claustrophobia
- Baclofen pump
A regiszterben nem jelölt feltételek
- Participant Screening:
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological assessment examination to determine the level and completeness of SCI when participants screen for entry into the study. The ISNCSCI exam will be performed by the study physician using a tool that assesses sensory function (light touch and pinprick) in each dermatome (A dermatome is an area of skin that sends touch, pain, temperature, and other sensory signals back to the brain) and motor function (motor function is a general term to describe the way muscles create movement) in ten key muscles. This test will determine the level of SCI, defined as the lowest spinal level with normal function, and assigns a classification of severity according to the ISNCSCI scale. In this study, both ISNCSCI grade C and grade D would make a participant eligible for this study.
- DXA study to assess bone mineral density (BMD) at the total hip (TH), distal femur (DF), and proximal tibia (PT) that will be compared to the cutoff values described in the exclusion criteria section.
- 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.
- Inclusion Criteria:
- 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).
- Exclusion Criteria:
- 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
- Positive pregnancy test at any of the study intervention or assessment visits, or if female participants plan to become pregnant over the course of the study, they will be excluded or withdrawn (if already enrolled) from participation.
- Currently in a gym/rehabilitation program performing ambulatory interventions such as EAW, as determined by the study staff.
- Currently prescribed any medications that can affect muscle and/or bone metabolism, as determined by the study staff.
Életkor a regiszterben: 21 év – 60 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Kessler Foundation | West Orange | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.