Sport InjuryNCT06695728
Hybrid Assistive Limb Effect on Jump Height: a Clinical Study
A study testing exercise in people with Sport Injury, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of exercises performed with The Hybrid Assistive Limb device on the jump height of healthy non-athlete individuals. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sport Injury
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2024to 23 Feb 2025
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 20 and 40 years old.
- Tall individuals over 120 cm (for accurate visual feedback in the assessment of jump height)
- Weighting less than 100 kg
- People who can perceive and follow the given instructions without any problems
- People who have not had any surgery in the last 6 months
- People who are not allergic to electrodes
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- They should not have any skin tissue related disorders.
- People who do not use pacemakers
- People who do not have a history of seizures or a risk of seizures (epilepsy).
- They should not have heart and respiratory problems.
- People who have not experienced back pain in the last 3 months.
- People whose waist circumference is not more than 120 cm and whose thigh circumference is not more than 80 cm.
- No orthopedic or neurological problems that will affect the balance mechanism (e.g. Vertigo, cerebellum damage, ataxia).
- Not having used a Waist Type Hybrid Assistive Limb device before
- Not having worked with visual feedback devices such as Tecnobody D-Wall before
- Not having worked with any of the Cyberdyne Hybrid Assistive Limb devices before
Who cannot join
- People with back pain or who have had surgery on their back
- Having had surgery within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the effect of exercises performed with The Hybrid Assistive Limb device on the jump height of healthy non-athlete individuals.
Read the detailed description
Cyberdyne Waist Type device will be worn by attaching 3 electrodes to the waist area and then attaching the device to the waist and legs with the help of belts. Then, the appropriate modes will be selected for the participant with the adjustments made on the device. It has 3 modes; CVC, the mode that produces torque value, that is, movement, according to muscle activation with only the bioelectric signals received from the person's skin. CAC, the mode that produces movement by presenting automatic values to the participant with data designed according to the specific software and algorithm of the device. CIC, the mode that produces movement completely according to the participant's control. In our study, investigators will produce movement according to the muscle activation created by the participant using the CVC mode. In this way, investigators will provide the brain-muscle relationship and motor learning parameters. The exercises will be applied for 30 minutes, 5 days a week, for a total of 40 sessions.
- Conditions
- Sport Injury
- Being tested
- exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
It consists of exercises to be done with the exoskeleton. These are; jumping exercise, squat, sit-stand and forward bending exercises.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Assistive Limb Group | Experimental | exoskeleton Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-Wall (TecnoBody SRL, Italy)
D-Wall (TecnoBody SRL, Italy) is a digital mirror device consisting of a powerful platform paired with a control computer and a high-resolution 3D Kinect camera equipped with infrared beams that allow for motion capture. The system provides instant feedback on the patient's movements on a large LCD monitor, offering VR-based mirror therapy and game-based exercises.This device measures the jump height and the amount of power consumed. It records the data and presents the result numerically.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start19 Nov 2024
- Primary completion20 Jan 2025
- Study completion23 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sport InjuryStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Aziz Azizov, Study chair, Uskudar UniversitySerhat Aslan, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695728
- Sponsor's protocol ID
- Uskudar16
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moll F, Kessel A, Bonetto A, Stresow J, Herten M, Dudda M, Adermann J. Use of Robot-Assisted Gait Training in Pediatric Patients with Cerebral Palsy in an Inpatient Setting-A Randomized Controlled Trial. Sensors (Basel). 2022 Dec 16;22(24):9946. doi: 10.3390/s22249946.
PubMed 36560316Watanabe H, Tsurushima H, Yanagi H. Effect of hybrid assistive limb treatment on maximal walking speed and six-minute walking distance during stroke rehabilitation: a pilot study. J Phys Ther Sci. 2021 Feb;33(2):168-174. doi: 10.1589/jpts.33.168. Epub 2021 Feb 13.
PubMed 33642694Matsuda M, Iwasaki N, Mataki Y, Mutsuzaki H, Yoshikawa K, Takahashi K, Enomoto K, Sano K, Kubota A, Nakayama T, Nakayama J, Ohguro H, Mizukami M, Tomita K. Robot-assisted training using Hybrid Assistive Limb(R) for cerebral palsy. Brain Dev. 2018 Sep;40(8):642-648. doi: 10.1016/j.braindev.2018.04.004. Epub 2018 Jul 14.
PubMed 29773349
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Assistive Limb Effect on Jump Height: a Clinical Study
- ClinicalTrials.gov ID
- NCT06695728
- Acronym / sponsor ID
- Uskudar16
- Conditions
- Sport Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 23 Feb 2025 (actual)
- First posted
- 19 Nov 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.
The aim of this study is to investigate the effect of exercises performed with The Hybrid Assistive Limb device on the jump height of healthy non-athlete individuals.
Detailed description
Cyberdyne Waist Type device will be worn by attaching 3 electrodes to the waist area and then attaching the device to the waist and legs with the help of belts. Then, the appropriate modes will be selected for the participant with the adjustments made on the device. It has 3 modes; CVC, the mode that produces torque value, that is, movement, according to muscle activation with only the bioelectric signals received from the person's skin. CAC, the mode that produces movement by presenting automatic values to the participant with data designed according to the specific software and algorithm of the device. CIC, the mode that produces movement completely according to the participant's control. In our study, investigators will produce movement according to the muscle activation created by the participant using the CVC mode. In this way, investigators will provide the brain-muscle relationship and motor learning parameters. The exercises will be applied for 30 minutes, 5 days a week, for a total of 40 sessions.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid Assistive Limb Group | Experimental | Other: exerciseexoskeleton |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Being between 20 and 40 years old.
- Tall individuals over 120 cm (for accurate visual feedback in the assessment of jump height)
- Weighting less than 100 kg
- People who can perceive and follow the given instructions without any problems
- People who have not had any surgery in the last 6 months
Key exclusion criteria (2 listed)
- People with back pain or who have had surgery on their back
- Having had surgery within the last 6 months.
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 |
|---|---|---|
| exerciseIt consists of exercises to be done with the exoskeleton. These are; jumping exercise, squat, sit-stand and forward bending exercises. | Other | Hybrid Assistive Limb Group |
Primary outcome
D-Wall (TecnoBody SRL, Italy)
Time frame: 8 weeks
D-Wall (TecnoBody SRL, Italy) is a digital mirror device consisting of a powerful platform paired with a control computer and a high-resolution 3D Kinect camera equipped with infrared beams that allow for motion capture. The system provides instant feedback on the patient's movements on a large LCD monitor, offering VR-based mirror therapy and game-based exercises.This device measures the jump height and the amount of power consumed. It records the data and presents the result numerically.
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 25 Feb 2025.
- Background: PubMed 36560316Moll F, Kessel A, Bonetto A, Stresow J, Herten M, Dudda M, Adermann J. Use of Robot-Assisted Gait Training in Pediatric Patients with Cerebral Palsy in an Inpatient Setting-A Randomized Controlled Trial. Sensors (Basel). 2022 Dec 16;22(24):9946. doi: 10.3390/s22249946.
- Background: PubMed 33642694Watanabe H, Tsurushima H, Yanagi H. Effect of hybrid assistive limb treatment on maximal walking speed and six-minute walking distance during stroke rehabilitation: a pilot study. J Phys Ther Sci. 2021 Feb;33(2):168-174. doi: 10.1589/jpts.33.168. Epub 2021 Feb 13.
- Background: PubMed 29773349Matsuda M, Iwasaki N, Mataki Y, Mutsuzaki H, Yoshikawa K, Takahashi K, Enomoto K, Sano K, Kubota A, Nakayama T, Nakayama J, Ohguro H, Mizukami M, Tomita K. Robot-assisted training using Hybrid Assistive Limb(R) for cerebral palsy. Brain Dev. 2018 Sep;40(8):642-648. doi: 10.1016/j.braindev.2018.04.004. Epub 2018 Jul 14.
- Individual participant dataSharing planned: No
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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.
Aziz Azizov study chair
Uskudar University
Serhat Aslan study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Sport Injury, run by Uskudar 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 16 inclusion and 2 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 25 Feb 2025. 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?
D-Wall (TecnoBody SRL, Italy) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06695728, which also lists 3 linked publications.
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 25 Feb 2025.