Clinical trial NCT06695728: Hybrid Assistive Limb Effect on Jump Height: a Clinical Study
Official title: Hybrid Assistive Limb Effect on Jump Height: a Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sport Injury
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: D-Wall (TecnoBody SRL, Italy)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cybernıcx
Study officials:
affiliation: Uskudar University
name: Aziz Azizov
role: STUDY_CHAIR
affiliation: Uskudar University
name: Serhat Aslan
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.