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

NCT06516380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-07-24

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Ankara Yildirim Beyazıt University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
33 Years
Max Age
33 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2024-06-10
Completion
2024-06-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516380 on ClinicalTrials.gov