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临床试验/NCT06516380
NCT06516380已完成不适用

Comprehensive Analysis of Cyberdyne HAL Single Joint, TecnoBody D-Wall, and Walker View 3.0 SCX Combined Therapy on Gait and Balance in a Post-Cartilage Knee Mosaicplasty Patient: A Detailed Case Study

Ankara Yildirim Beyazıt University2 个研究点 分布在 2 个国家目标入组 1 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
2
主要终点
Range of Motion

研究概览

简要总结

Mosaicplasty is a procedure where grafts taken from almost non-load-bearing areas of the joint are used to reconstruct lesioned areas. Hangody and his team developed this method using small cylindrical grafts and named it mosaicplasty (1). With the adoption of this approach, both the morbidity of the donor area has decreased, and a better joint surface has been achieved in the grafted area. Some studies have shown that 80% of this newly formed composite cartilage has a hyaline structure (2).

The Cyberdyne Hybrid Assistive Limb (HAL) - Single Joint (SJ) (HAL-SJ, Cyberdyne Inc., Tsukuba, Japan) is a wearable exoskeleton that facilitates voluntary control of knee joint movement. This exoskeleton processes signals from muscle action potentials detected by electrodes on the skin surface and assists the patient with joint movements. The knee joint power unit includes angular sensors and actuators, and the control system consists of Cybernetic Voluntary Control (CVC) and Cybernetic Autonomous Control (CAC) systems (3). HAL has been found to be effective in the functional improvement of various mobility disorders (4-7).

The TecnoBody Walker View (Bergamo, Italy) is used to analyze asymmetries and changes in joint range of motion. It can also be used to provide gait training, supporting weights ranging from 20% to 80%, and offers a safe walking rehabilitation option. The TecnoBody D-Wall is an assessment and rehabilitation device designed to improve movement quality with auditory and visual feedback. This device evaluates individuals' balance in seconds/mm² with eyes open (EO) and eyes closed (EC) conditions (8).

Although studies to date have reported successful outcomes for acute or chronic mobility disorders, there is limited literature on the use of HAL-SJ for cartilage rehabilitation or related postoperative recovery. Therefore, this study aims to investigate the effects of a combined treatment protocol involving HAL-SJ-based knee extension and flexion exercises with TecnoBody D-Wall and Walker View devices on gait parameters and balance during the acute recovery phase following mosaicplasty cartilage surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
33 Years 至 33 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patient aged 33 years.
  • Body weight of 70 kg and height of 180 cm.
  • Underwent knee mosaicplasty surgery on the right knee in November
  • Presence of postoperative complications, including affected gait, reduced range of motion (ROM) in the knee joint, and edema.
  • Ability to participate in intensive rehabilitation sessions (5 days a week, 2 hours per day) for 3 months.

排除标准

  • Patients with severe cardiovascular, pulmonary, or neurological disorders that could affect participation in the rehabilitation program.
  • Presence of any other musculoskeletal conditions that could interfere with the study outcomes.
  • Patients with uncontrolled metabolic disorders such as diabetes.
  • Inability to follow the prescribed rehabilitation protocol due to personal or logistical reasons.
  • Participation in any other physical therapy or rehabilitation program during the study period.

结局指标

主要结局

Range of Motion

时间窗: 4 weeks

trunk flexion, hip flexion and knee flexion ROMs were measured at the end of the 20th session

Lower limb strength

时间窗: 4 weeks

A 30 s sit and stand test was performed to evaluate lower extremity strength.

10 metre walking test (10 MWT)

时间窗: 4 weeks

The 10 Meter Walking Test (10 MWT) is used to evaluate walking performance

Balance assessment

时间窗: 4 weeks

Balance assessment was performed on D-Wall device

次要结局

未报告次要终点

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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