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Completed

NCT Number: NCT06516380

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

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.

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Key information

Conditions

Mosaicplasty Cyberdyne Single Joint TecnoBody

Age range

33 year–33 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Ankara, Etlik, 06010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Range of Motion

    Time frame: 4 weeks

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

  2. Lower limb strength

    Time frame: 4 weeks

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

  3. Balance assessment

    Time frame: 4 weeks

    Balance assessment was performed on D-Wall device

  4. 10 metre walking test (10 MWT)

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.