NCT05688566

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

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

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

December 25, 2022

Last Update Submit

January 15, 2023

Conditions

Keywords

biomechanical characteristics of lower extremityPinnacle trainerpedal angles

Outcome Measures

Primary Outcomes (2)

  • lower limb movement

    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

    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

Study Arms (3)

zero condition

EXPERIMENTAL

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

eversion codition

ACTIVE COMPARATOR

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

inversion condition

ACTIVE COMPARATOR

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

Interventions

The pinnacle trainer (S776MA, SportsArt, Taiwan) was used in this study.

eversion coditioninversion conditionzero condition

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, Taiwan

Location

Related Publications (16)

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    PMID: 27451059BACKGROUND
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Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The subject already knows the angle of the pedal when he steps on the pedal, because there are only three angles.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Then the pedal angle are inversion 10 ˚,0 ˚, eversion 10˚. Participants stepped on the Pinnacle trainer under three angle levels, namely inversion 10 ˚,0 ˚, eversion 10˚.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

December 25, 2022

First Posted

January 18, 2023

Study Start

July 1, 2022

Primary Completion

December 26, 2022

Study Completion

January 15, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations