- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06695728
Hybrid Assistive Limb Effect on Jump Height: a Clinical Study
February 24, 2025 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Cybernıcx
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- People with back pain or who have had surgery on their back
- Having had surgery within the last 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hybrid Assistive Limb Group
exoskeleton
|
It consists of exercises to be done with the exoskeleton.
These are; jumping exercise, squat, sit-stand and forward bending exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Aziz Azizov, Uskudar University
- Study Chair: Serhat Aslan, Uskudar University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Watanabe 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.
- Matsuda 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2024
Primary Completion (Actual)
January 20, 2025
Study Completion (Actual)
February 23, 2025
Study Registration Dates
First Submitted
November 14, 2024
First Submitted That Met QC Criteria
November 15, 2024
First Posted (Actual)
November 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 24, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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