Biomechanical Characteristics of Lower Extremity During Pinnacle Trainer With Different Pedal Angles

January 15, 2023 updated by: Fong Chin Su, National Cheng-Kung University Hospital

攀爬機踏板在不同角度下對於下肢生物力學影響 Biomechanical Characteristics of Lower Extremity During Pinnacle Trainer With Different Pedal Angles.

To investigate the effects of pedal degree on the biomechanical characteristics of the healthy adults' lower limbs during stepping on the pinnacle trainer.The purpose of this study are compare the biomechanical characteristics of low limbs at different angle of pedal during stepping on Pinnacle trainer. The investigators hope to provide this outcome to therapists can make the rehabilitation training more effective and delay the disease progression of KOA patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The pedal angle influences the force distribution in the lower extremities. Although we have seen the angle of the pedal selected of the bicycle and a lot of insole paper, the previous paper did not see adjusting the pedal angle of the pinnacle trainer. However, the joint loading and force distribution during stepping on a pinnacle trainer with various pedal angle are unknown. The investigation of biomechanics of the lower extremity is important to provide information about the joint loadings and prevent potential injuries during exercise.According to the World Health Organization, by 2050, people over 60 years old will account for nearly 22% of the world's population. Of that 22%, a conservative estimate of 15% will have symptomatic OA. It is estimated that by 2050, nearly 130 million people worldwide will suffer from OA, and 40 million people will gradually affect their lives and be severely disabled due to osteoarthritis by 2050. Knee Osteoarthritis accounts for more than 80% of the global OA disease burden. And previous studies suggested that the use of the Pinnacle Trainer for individual with knee OA is effective on the improvement of pain intensity, physical functions and the muscular strength of the low extremity. And the internal knee abduction moment demonstrated a tendency toward to reduce after the Pinnacle Trainer intervention. Hence, the reduction of excessive internal knee abduction moment is beneficial for some users. On the other hand, the internal knee abduction moment is related to the severity of the knee OA.

The majority of research has focused specifically on the effect of lateral wedge insoles at the knee, and numerous of studies have concentrated on pedals on stationary cycling. Those studies suggested that the foot everted position reduced the KAM. However, few studies investigated the angle of pedal during the CKC exercise equipment. However, the biomechanical characteristics during stepping on Pinnacle Trainer with different pedal angles are unknown. The investigators wanted to explore the biomechanical characteristics of lower extremity during pinnacle trainer with different pedal angles and further explore whether KAM can be effectively reduced by changing the angle of the wedge to assist the training of KOA patients.

The purpose of this study are compare the biomechanical characteristics of low limbs at different angle of pedal during stepping on Pinnacle trainer. The investigators hope to provide this outcome to therapists can make the rehabilitation training more effective and delay the disease progression of KOA patients.

Study Type

Interventional

Enrollment (Actual)

18

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

  • Taiwan
      • Tainan, Taiwan
        • National Cheng Kung University

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

30 healthy individuals above 20 years and will be recruited in this study. 30 participants will be recruited with considering the inclusion criteria as follows:

  1. 20 years old above
  2. Able to perform regular exercise
  3. Able to understand Chinese or Taiwanese language
  4. Healthy adult (no skeletal muscle, neurological disease, normal BMI (18.5≦BMI<25.0), and no disease that will affect training.

Exclusion Criteria:

  1. Having illness or diseases that cannot perform physical exercise
  2. Having any kinds of chronic disease that might be more activated by performing Pinnacle training such as cardiovascular diseases, chronic respiratory diseases, osteoporosis, etc.
  3. Having chronic diseases that cannot perform Pinnacle training according to the experimental protocols such as blindness, deafness and hearing impairment, etc.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zero condition
Then the pedal angle is the angle between the lowest pedal position and the floor. The zero condition is 0 ˚of pedal angle.Participants were asked to step with the consistent cadence at 60 steps/ min by the metronome.Three successful trials will be collected for each condition. Fifteen seconds of data will be collected for each trial.
Device: pinnacle trainer
The pinnacle trainer (S776MA, SportsArt, Taiwan) was used in this study.
Active Comparator: eversion codition
Then the pedal angle is the angle between the lowest pedal position and the floor. The eversion condition is -10 ˚of pedal angle.Participants were asked to step with the consistent cadence at 60 steps/ min by the metronome.Three successful trials will be collected for each condition. Fifteen seconds of data will be collected for each trial.
Device: pinnacle trainer
The pinnacle trainer (S776MA, SportsArt, Taiwan) was used in this study.
Active Comparator: inversion condition
Then the pedal angle is the angle between the lowest pedal position and the floor. The inversion condition is +10 ˚of pedal angle.Participants were asked to step with the consistent cadence at 60 steps/ min by the metronome.Three successful trials will be collected for each condition. Fifteen seconds of data will be collected for each trial.
Device: pinnacle trainer
The pinnacle trainer (S776MA, SportsArt, Taiwan) was used in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lower limb movement
Time Frame: 2 hours
A three-dimensional motion capture system with eight digital cameras (Osprey, Motion Analysis Corporation, USA) was used to collect the data of low limb motion. The sampling rate was set at 200 Hz. Reflective markers (10 mm in diameter) will be attached on the participant's skin at the positions with regards to Modified Helen-Hayes marker set.
2 hours
kinetics of lower limb
Time Frame: 2 hours
Two six-axis force and torque transducers (Mini85, ATI Industrial Automation, USA) with a sampling rate of 1000 Hz were placed under the pedals of the pinnacle trainer.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

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

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)

July 1, 2022

Primary Completion (Actual)

December 26, 2022

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

December 25, 2022

First Submitted That Met QC Criteria

January 15, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 111-356

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.

Clinical Trials on Healthy Adult

Clinical Trials on pinnacle trainer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe