Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle
NCT ID: NCT05888714
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2023-06-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental FES cycling
New medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling)
Experimental FES cycling
Using the experimental, new FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening.
Comparator FES cycling
Existing medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling)
Comparator FES cycling
Using the comparator, marketed FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening.
Conventional physical therapy
Conventional physical therapy.
Conventional physical therapy
Conventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks).
Operators
Operators will evaluate systems usability during interventions.
No interventions assigned to this group
Interventions
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Experimental FES cycling
Using the experimental, new FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening.
Comparator FES cycling
Using the comparator, marketed FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening.
Conventional physical therapy
Conventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks).
Eligibility Criteria
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Inclusion Criteria
* Managed chronic diseases
* No contraindications to the practice of physical exercise
* Ability to communicate in oral and written Portuguese
Exclusion Criteria
* Unstable or acute fractures of lower limbs
* Contraindication for the practice of physical activity
* Open wounds in the lower limbs
* Consent withdraw
18 Years
ALL
No
Sponsors
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Agência Brasileira de Desenvolvimento Industrial (Brazilian Agency For Industrial Development)
UNKNOWN
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Linamara R. Battistella, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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References
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Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
Scheuringer M, Grill E, Boldt C, Mittrach R, Mullner P, Stucki G. Systematic review of measures and their concepts used in published studies focusing on rehabilitation in the acute hospital and in early post-acute rehabilitation facilities. Disabil Rehabil. 2005 Apr 8-22;27(7-8):419-29. doi: 10.1080/09638280400014089.
De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8.
De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
Stoll T, Brach M, Huber EO, Scheuringer M, Schwarzkopf SR, Konstanjsek N, Stucki G. ICF Core Set for patients with musculoskeletal conditions in the acute hospital. Disabil Rehabil. 2005 Apr 8-22;27(7-8):381-7. doi: 10.1080/09638280400013990.
van der Schaaf M, Beelen A, Dongelmans DA, Vroom MB, Nollet F. Poor functional recovery after a critical illness: a longitudinal study. J Rehabil Med. 2009 Nov;41(13):1041-8. doi: 10.2340/16501977-0443.
Martin UJ, Hincapie L, Nimchuk M, Gaughan J, Criner GJ. Impact of whole-body rehabilitation in patients receiving chronic mechanical ventilation. Crit Care Med. 2005 Oct;33(10):2259-65. doi: 10.1097/01.ccm.0000181730.02238.9b.
Garnacho-Montero J, Amaya-Villar R, Garcia-Garmendia JL, Madrazo-Osuna J, Ortiz-Leyba C. Effect of critical illness polyneuropathy on the withdrawal from mechanical ventilation and the length of stay in septic patients. Crit Care Med. 2005 Feb;33(2):349-54. doi: 10.1097/01.ccm.0000153521.41848.7e.
Dittmer DK, Teasell R. Complications of immobilization and bed rest. Part 1: Musculoskeletal and cardiovascular complications. Can Fam Physician. 1993 Jun;39:1428-32, 1435-7.
Pinheiro AR, Christofoletti G. Motor physical therapy in hospitalized patients in an intensive care unit: a systematic review. Rev Bras Ter Intensiva. 2012 Jun;24(2):188-96. English, Portuguese.
Maddocks M, Armstrong S, Wilcock A. Exercise as a supportive therapy in incurable cancer: exploring patient preferences. Psychooncology. 2011 Feb;20(2):173-8. doi: 10.1002/pon.1720.
Other Identifiers
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CAAE 64324122.0.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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