NCT06695728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

November 14, 2024

Last Update Submit

February 24, 2025

Conditions

Sport Injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Study Arms (1)

Hybrid Assistive Limb Group

EXPERIMENTAL

exoskeleton

Other: exercise

Interventions

exerciseOTHER

It consists of exercises to be done with the exoskeleton. These are; jumping exercise, squat, sit-stand and forward bending exercises.

Hybrid Assistive Limb Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • People with back pain or who have had surgery on their back
  • Having had surgery within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cybernıcx

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 36560316BACKGROUND

  • 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.

    PMID: 33642694BACKGROUND

  • 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.

    PMID: 29773349BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aziz Azizov

    Uskudar University

    STUDY CHAIR

  • Serhat Aslan

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 19, 2024

Study Start

November 19, 2024

Primary Completion

January 20, 2025

Study Completion

February 23, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)