Spinal Cord Damage Research Center, James J. Peters VA Medical Center, Bronx, NY, USA
Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, New Brunswick, NJ, USA.
BMJ Open. 2024 Sep 17;14(9):e086062. doi: 10.1136/bmjopen-2024-086062.
Persons with non-ambulatory spinal cord injury (SCI) undergo immediate unloading of the skeleton and, as a result, have marked loss of bone mineral density below the level of lesion that is directly associated with increased risk of long-bone fractures. There is a paucity of research that has successfully implemented rehabilitation and/or exercise training interventions to mitigate bone loss after acute SCI or reverse bone loss that has already occurred in chronic SCI. This paper describes a research protocol to compare the effect of exoskeletal-assisted walking (EAW) alone versus EAW plus transcutaneous spinal cord stimulation (EAW+tSCS) on bone density, geometry and strength in a cohort of chronic SCI participants.
After meeting eligibility criteria and completing baseline testing, sixteen participants will be block randomised into the EAW alone group or the EAW+tSCS combined group (n=8 each group). Each group will receive a total of 108 overground training sessions (60 min sessions, 3 times a week, for 36 weeks) for the 9-month training period. Imaging for bone density and geometry by dual-energy X-ray absorptiometry and peripheral quantitative CT will be performed prior to starting the intervention (baseline), after 72 training sessions, and again after 108 sessions in each of the intervention arms. CT imaging of both lower extremities will be performed at baseline and at the 9-month time point in each of the intervention arms. Finite element models of bone loading will be generated based on three-dimensional (3D) reconstruction of bone architecture from CT imaging prior to and 9 months after the intervention.
This study is currently approved by the Kessler Foundation and James J. Peters VA Medical Center Institutional Review Board. A member of the research team will review and explain the study consent form and will have all eligible participants sign prior to participation in the study. Results from this study will be disseminated to clinicians and researchers in the SCI community at national and international conferences.
NCT03096197.
非卧床脊髓损伤（SCI）患者的骨骼会立即承受负荷，因此，在损伤水平以下会出现明显的骨矿物质密度丢失，这与长骨骨折的风险增加直接相关。目前，成功实施康复和/或运动训练干预以减轻急性 SCI 后骨丢失或逆转慢性 SCI 中已经发生的骨丢失的研究很少。本文描述了一项研究方案，以比较外骨骼辅助行走（EAW）单独使用与 EAW 加经皮脊髓电刺激（EAW+tSCS）联合使用对慢性 SCI 参与者骨密度、骨几何形状和骨强度的影响。
符合入选标准并完成基线测试后，16 名参与者将被随机分为 EAW 单独组或 EAW+tSCS 联合组（每组 8 名）。每个组将在 9 个月的训练期间接受总共 108 次地面训练（60 分钟/次，每周 3 次，共 36 周）。在开始干预（基线）前、72 次训练后和干预组的 108 次训练后，将进行双能 X 射线吸收法和外周定量 CT 骨密度和骨几何形状成像。在每个干预臂的基线和 9 个月时，将对双侧下肢进行 CT 成像。在干预前后，将根据 CT 成像的骨骼结构三维（3D）重建生成骨骼加载的有限元模型。
这项研究目前已经获得了凯斯勒基金会和詹姆斯 J. 彼得斯退伍军人医疗中心机构审查委员会的批准。研究团队的一名成员将审查并解释研究同意书，并在所有符合条件的参与者签署后参与研究。这项研究的结果将在全国和国际会议上向 SCI 社区的临床医生和研究人员传播。
NCT03096197。
