Healthy AdultNCT05688566
Biomechanical Characteristics of Lower Extremity During Pinnacle Trainer With Different Pedal Angles
A study testing pinnacle trainer in people with Healthy Adult, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- pinnacle trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2022to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 20 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Adult
- Being tested
- pinnacle trainer
- Keywords
- biomechanical characteristics of lower extremity, Pinnacle trainer, pedal angles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pinnacle trainerDevice
The pinnacle trainer (S776MA, SportsArt, Taiwan) was used in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: pinnacle trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Jul 2022
- Primary completion26 Dec 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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˚.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fong Chin Su, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688566
- Sponsor's protocol ID
- 111-356
- Status last verified
- Jan 2023
- First submitted
- 25 Dec 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu TW, Chien HL, Chen HL. Joint loading in the lower extremities during elliptical exercise. Med Sci Sports Exerc. 2007 Sep;39(9):1651-8. doi: 10.1249/mss.0b013e3180dc9970.
PubMed 17805099You YL, Lin CJ, Chieh HF, Tsai YJ, Lee SY, Lin CF, Hsu YC, Kuo LC, Su FC. Comparison of knee biomechanical characteristics during exercise between pinnacle and step trainers. Gait Posture. 2020 Mar;77:201-206. doi: 10.1016/j.gaitpost.2020.02.003. Epub 2020 Feb 4.
PubMed 32058284Stauffer RN, Chao EY, Brewster RC. Force and motion analysis of the normal, diseased, and prosthetic ankle joint. Clin Orthop Relat Res. 1977;(127):189-96.
PubMed 912978Foroughi N, Smith R, Vanwanseele B. The association of external knee adduction moment with biomechanical variables in osteoarthritis: a systematic review. Knee. 2009 Oct;16(5):303-9. doi: 10.1016/j.knee.2008.12.007. Epub 2009 Mar 24.
PubMed 19321348Haim A, Wolf A, Rubin G, Genis Y, Khoury M, Rozen N. Effect of center of pressure modulation on knee adduction moment in medial compartment knee osteoarthritis. J Orthop Res. 2011 Nov;29(11):1668-74. doi: 10.1002/jor.21422. Epub 2011 Apr 13.
PubMed 21491477Chang SY, Lin YJ, Hsu WC, Hsieh LF, Lin YH, Chang CC, Chou YC, Chen LF. Exercise Alters Gait Pattern but Not Knee Load in Patients with Knee Osteoarthritis. Biomed Res Int. 2016;2016:7468937. doi: 10.1155/2016/7468937. Epub 2016 Sep 20.
PubMed 27725941Thorp LE, Wimmer MA, Foucher KC, Sumner DR, Shakoor N, Block JA. The biomechanical effects of focused muscle training on medial knee loads in OA of the knee: a pilot, proof of concept study. J Musculoskelet Neuronal Interact. 2010 Jun;10(2):166-73.
PubMed 20516634Butler RJ, Marchesi S, Royer T, Davis IS. The effect of a subject-specific amount of lateral wedge on knee mechanics in patients with medial knee osteoarthritis. J Orthop Res. 2007 Sep;25(9):1121-7. doi: 10.1002/jor.20423.
PubMed 17469197Hinman RS, Bowles KA, Metcalf BB, Wrigley TV, Bennell KL. Lateral wedge insoles for medial knee osteoarthritis: effects on lower limb frontal plane biomechanics. Clin Biomech (Bristol). 2012 Jan;27(1):27-33. doi: 10.1016/j.clinbiomech.2011.07.010. Epub 2011 Sep 8.
PubMed 21862189Kean CO, Bennell KL, Wrigley TV, Hinman RS. Modified walking shoes for knee osteoarthritis: Mechanisms for reductions in the knee adduction moment. J Biomech. 2013 Aug 9;46(12):2060-6. doi: 10.1016/j.jbiomech.2013.05.011. Epub 2013 Jun 14.
PubMed 23768609Resende RA, Kirkwood RN, Deluzio KJ, Hassan EA, Fonseca ST. Ipsilateral and contralateral foot pronation affect lower limb and trunk biomechanics of individuals with knee osteoarthritis during gait. Clin Biomech (Bristol). 2016 May;34:30-7. doi: 10.1016/j.clinbiomech.2016.03.005. Epub 2016 Mar 24.
PubMed 27060435Fisher DS, Dyrby CO, Mundermann A, Morag E, Andriacchi TP. In healthy subjects without knee osteoarthritis, the peak knee adduction moment influences the acute effect of shoe interventions designed to reduce medial compartment knee load. J Orthop Res. 2007 Apr;25(4):540-6. doi: 10.1002/jor.20157.
PubMed 17205556Gregersen CS, Hull ML, Hakansson NA. How changing the inversion/eversion foot angle affects the nondriving intersegmental knee moments and the relative activation of the vastii muscles in cycling. J Biomech Eng. 2006 Jun;128(3):391-8. doi: 10.1115/1.2193543.
PubMed 16706588Gardner JK, Klipple G, Stewart C, Asif I, Zhang S. Acute effects of lateral shoe wedges on joint biomechanics of patients with medial compartment knee osteoarthritis during stationary cycling. J Biomech. 2016 Sep 6;49(13):2817-2823. doi: 10.1016/j.jbiomech.2016.06.016. Epub 2016 Jun 23.
PubMed 27451059Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2.
PubMed 23245607
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05688566
- Acronym / sponsor ID
- 111-356
- Conditions
- Healthy Adult
- Keywords
- biomechanical characteristics of lower extremity, Pinnacle trainer, pedal angles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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˚.
| Arm | Type | Receives |
|---|---|---|
| zero condition | Experimental | Device: pinnacle trainerThen 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. |
| eversion codition | Active comparator | Device: pinnacle trainerThen 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. |
| inversion condition | Active comparator | Device: pinnacle trainerThen 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 20 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pinnacle trainerThe pinnacle trainer (S776MA, SportsArt, Taiwan) was used in this study. | Device | eversion codition, inversion condition, zero condition |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 17805099Lu TW, Chien HL, Chen HL. Joint loading in the lower extremities during elliptical exercise. Med Sci Sports Exerc. 2007 Sep;39(9):1651-8. doi: 10.1249/mss.0b013e3180dc9970.
- Background: PubMed 32058284You YL, Lin CJ, Chieh HF, Tsai YJ, Lee SY, Lin CF, Hsu YC, Kuo LC, Su FC. Comparison of knee biomechanical characteristics during exercise between pinnacle and step trainers. Gait Posture. 2020 Mar;77:201-206. doi: 10.1016/j.gaitpost.2020.02.003. Epub 2020 Feb 4.
- Background: PubMed 912978Stauffer RN, Chao EY, Brewster RC. Force and motion analysis of the normal, diseased, and prosthetic ankle joint. Clin Orthop Relat Res. 1977;(127):189-96.
- Background: PubMed 19321348Foroughi N, Smith R, Vanwanseele B. The association of external knee adduction moment with biomechanical variables in osteoarthritis: a systematic review. Knee. 2009 Oct;16(5):303-9. doi: 10.1016/j.knee.2008.12.007. Epub 2009 Mar 24.
- Background: PubMed 21491477Haim A, Wolf A, Rubin G, Genis Y, Khoury M, Rozen N. Effect of center of pressure modulation on knee adduction moment in medial compartment knee osteoarthritis. J Orthop Res. 2011 Nov;29(11):1668-74. doi: 10.1002/jor.21422. Epub 2011 Apr 13.
- Background: PubMed 27725941Chang SY, Lin YJ, Hsu WC, Hsieh LF, Lin YH, Chang CC, Chou YC, Chen LF. Exercise Alters Gait Pattern but Not Knee Load in Patients with Knee Osteoarthritis. Biomed Res Int. 2016;2016:7468937. doi: 10.1155/2016/7468937. Epub 2016 Sep 20.
- Background: PubMed 20516634Thorp LE, Wimmer MA, Foucher KC, Sumner DR, Shakoor N, Block JA. The biomechanical effects of focused muscle training on medial knee loads in OA of the knee: a pilot, proof of concept study. J Musculoskelet Neuronal Interact. 2010 Jun;10(2):166-73.
- Background: PubMed 17469197Butler RJ, Marchesi S, Royer T, Davis IS. The effect of a subject-specific amount of lateral wedge on knee mechanics in patients with medial knee osteoarthritis. J Orthop Res. 2007 Sep;25(9):1121-7. doi: 10.1002/jor.20423.
- Background: PubMed 21862189Hinman RS, Bowles KA, Metcalf BB, Wrigley TV, Bennell KL. Lateral wedge insoles for medial knee osteoarthritis: effects on lower limb frontal plane biomechanics. Clin Biomech (Bristol). 2012 Jan;27(1):27-33. doi: 10.1016/j.clinbiomech.2011.07.010. Epub 2011 Sep 8.
- Background: PubMed 23768609Kean CO, Bennell KL, Wrigley TV, Hinman RS. Modified walking shoes for knee osteoarthritis: Mechanisms for reductions in the knee adduction moment. J Biomech. 2013 Aug 9;46(12):2060-6. doi: 10.1016/j.jbiomech.2013.05.011. Epub 2013 Jun 14.
- Background: PubMed 27060435Resende RA, Kirkwood RN, Deluzio KJ, Hassan EA, Fonseca ST. Ipsilateral and contralateral foot pronation affect lower limb and trunk biomechanics of individuals with knee osteoarthritis during gait. Clin Biomech (Bristol). 2016 May;34:30-7. doi: 10.1016/j.clinbiomech.2016.03.005. Epub 2016 Mar 24.
- Background: PubMed 17205556Fisher DS, Dyrby CO, Mundermann A, Morag E, Andriacchi TP. In healthy subjects without knee osteoarthritis, the peak knee adduction moment influences the acute effect of shoe interventions designed to reduce medial compartment knee load. J Orthop Res. 2007 Apr;25(4):540-6. doi: 10.1002/jor.20157.
- Individual participant dataSharing planned: No
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Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pinnacle trainer in people with Healthy Adult, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower limb movement (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05688566, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.