Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05688566
Other study ID # 111-356
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date January 15, 2023

Study information

Verified date January 2023
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The investigators hope to provide this outcome to therapists can make the rehabilitation training more effective and delay the disease progression of KOA patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date January 15, 2023
Est. primary completion date December 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan National Cheng Kung University Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (16)

Butler 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. — View Citation

Chang 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. — View Citation

Fisher 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. — View Citation

Foroughi 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. — View Citation

Gardner 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. — View Citation

Gregersen 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. — View Citation

Haim 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. — View Citation

Hinman 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, Avon). 2012 Jan;27(1):27-33. doi: 10.1016/j.clinbiomech.2011.07.010. Epub 2011 Sep 8. — View Citation

Kean 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. — View Citation

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. — View Citation

Resende 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, Avon). 2016 May;34:30-7. doi: 10.1016/j.clinbiomech.2016.03.005. Epub 2016 Mar 24. — View Citation

Stauffer 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. — View Citation

Thorp 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. — View Citation

Vos 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. Erratum In: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added]. — View Citation

You 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. — View Citation

Zimmermann CL, Cook TM, Bravard MS, Hansen MM, Honomichl RT, Karns ST, Lammers MA, Steele SA, Yunker LK, Zebrowski RM. Effects of stair-stepping exercise direction and cadence on EMG activity of selected lower extremity muscle groups. J Orthop Sports Phys Ther. 1994 Mar;19(3):173-80. doi: 10.2519/jospt.1994.19.3.173. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT02257151 - Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects Phase 1
Completed NCT06169059 - To Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004 Phase 1
Completed NCT06165965 - To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008 Phase 1
Completed NCT01506739 - A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males Phase 1
Completed NCT00400309 - Safety of REPEVAX® Given One Month After REVAXIS® Phase 3
Completed NCT04027218 - Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture. N/A
Completed NCT05408572 - Study of SON-1010 (IL12-FHAB) in Healthy Adults Early Phase 1
Not yet recruiting NCT04964245 - Respiratory Measurement of Volume Change Using Accelerometer, Thermographic Camera Electrical Impedance Tomography and Motion Correlation Analysis Using Mattress Sensor in Healthy Individuals N/A
Completed NCT01506752 - A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males Phase 1
Completed NCT03827005 - L-arginine Supplementation and Resistance Exercise N/A
Completed NCT06171880 - To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901 Phase 1
Completed NCT01274130 - Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers N/A
Withdrawn NCT04762823 - Multiple Sessions of Transcranial Direct Current Stimulation in People With Parkinson's Disease N/A
Recruiting NCT06385639 - Efficacy and Safety of Probiotic Products for Digestive Health N/A
Not yet recruiting NCT06344533 - Study of JMKX003142 Injection in Chinese Healthy Subjects Phase 1