Cyberdyne HAL, TecnoBody D-Wall, and Walker View 3.0 SCX Combined Treatment
NCT Number: NCT06516380
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mosaicplasty|Cyberdyne|Single Joint|TecnoBody
Interventions: DEVICE: Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devices
Sponsor: Ankara Yildirim Beyazıt University
Sex: MALE
Age: ADULT
Enrollment: 1
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-30
Completion Date: 2024-06-30
Locations: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Etlik, 06010, Turkey

Summary:
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.

Primary Outcome Measures: Range of Motion, trunk flexion, hip flexion and knee flexion ROMs were measured at the end of the 20th session, 4 weeks|Lower limb strength, A 30 s sit and stand test was performed to evaluate lower extremity strength., 4 weeks|Balance assessment, Balance assessment was performed on D-Wall device, 4 weeks|10 metre walking test (10 MWT), The 10 Meter Walking Test (10 MWT) is used to evaluate walking performance, 4 weeks