MosaicplastyNCT06516380
Cyberdyne HAL, TecnoBody D-Wall, and Walker View 3.0 SCX Combined Treatment
A study testing Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devices in people with Mosaicplasty and Cyberdyne, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 33 to 33 years, men only
- Conditions the study is for
- Mosaicplasty, Cyberdyne, Single Joint
- What is being tested?
- Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 33 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara, Etlik, 06010
About this study
Official 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
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).
Read more
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
- Being tested
- Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devicesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| lower extremity strength | No intervention | A 30 s sit and stand test was performed to evaluate lower extremity strength. |
| walking test | No intervention | The 10-metre walking test (10 MWT) and timed up and walk test (TUG) were performed. |
| ROM | Experimental | Hip ROM, knee ROM, trunk flexion ROM were measured with TecnoBody Walker View 3.0 SCX device. Receives: Device: Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
trunk flexion, hip flexion and knee flexion ROMs were measured at the end of the 20th session
Measured: 4 weeks
Lower limb strength
A 30 s sit and stand test was performed to evaluate lower extremity strength.
Measured: 4 weeks
Balance assessment
Balance assessment was performed on D-Wall device
Measured: 4 weeks
10 metre walking test (10 MWT)
The 10 Meter Walking Test (10 MWT) is used to evaluate walking performance
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start30 May 2024
- Primary completion10 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MosaicplastyStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516380
- Sponsor's protocol ID
- 2024-45
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06516380
- Acronym / sponsor ID
- 2024-45
- Conditions
- Mosaicplasty, Cyberdyne, Single Joint, TecnoBody
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lower extremity strength | No intervention | –A 30 s sit and stand test was performed to evaluate lower extremity strength. |
| walking test | No intervention | –The 10-metre walking test (10 MWT) and timed up and walk test (TUG) were performed. |
| ROM | Experimental | Device: Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devicesHip ROM, knee ROM, trunk flexion ROM were measured with TecnoBody Walker View 3.0 SCX device. |
Who may qualify
- Ages
- 33 to 33 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devicesHAL-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. | Device | ROM |
Primary outcome
Range of Motion
Time frame: 4 weeks
trunk flexion, hip flexion and knee flexion ROMs were measured at the end of the 20th session
Lower limb strength
Time frame: 4 weeks
A 30 s sit and stand test was performed to evaluate lower extremity strength.
Balance assessment
Time frame: 4 weeks
Balance assessment was performed on D-Wall device
10 metre walking test (10 MWT)
Time frame: 4 weeks
The 10 Meter Walking Test (10 MWT) is used to evaluate walking performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined treatment of Cyberdyne HAL single joint with TecnoBody D-Wall and Walker View 3.0 SCX devices in people with Mosaicplasty and Cyberdyne, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.