Cyberdyne HAL, TecnoBody D-Wall, and Walker View 3.0 SCX Combined Treatment

NCT ID: NCT06516380

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2024-06-30

Brief 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.

Conditions

Mosaicplasty; Cyberdyne; Single Joint; TecnoBody

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lower extremity strength

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

walking test

The 10-metre walking test (10 MWT) and timed up and walk test (TUG) were performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ROM

Hip ROM, knee ROM, trunk flexion ROM were measured with TecnoBody Walker View 3.0 SCX device.

Group Type: EXPERIMENTAL

Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devices

Intervention Type: DEVICE

HAL-SJ sessions were conducted 5 days a week for 3 months and 2 hours a day for a total of 60 sessions. HAL-SJ application was performed in cybernic voluntary control (CVC) mode for 90 minutes. In addition to each HAL-SJ session, balance exercises were performed with TecnoBody D-Wall for 30 minutes net.

Interventions

Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devices

HAL-SJ sessions were conducted 5 days a week for 3 months and 2 hours a day for a total of 60 sessions. HAL-SJ application was performed in cybernic voluntary control (CVC) mode for 90 minutes. In addition to each HAL-SJ session, balance exercises were performed with TecnoBody D-Wall for 30 minutes net.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 2023.
• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 33 Years
• Maximum Eligible Age: 33 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Etlik, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024-45

Identifier Type: -

Identifier Source: org_study_id