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| Name | Class |
|---|---|
| Agência Brasileira de Desenvolvimento Industrial (Brazilian Agency For Industrial Development) | UNKNOWN |
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Feasibility study of a new medical device that will evaluate the usability and effectiveness of a cycle ergometer device associated with neuromuscular electrical stimulation (FES cycling). The study's objective is to evaluate the effect of the application of functional electrical stimulation of the new device on participants' quadriceps muscle strength in comparison to a medical device with similar characteristics and to a control group. Secondarily, the study will compare the usability of the two medical devices as evaluated by the participants and the therapists who apply the treatment, as well as the participants' satisfaction with the treatment, identifying possible adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental FES cycling | Experimental | New medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling) |
|
| Comparator FES cycling | Active Comparator | Existing medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling) |
|
| Conventional physical therapy | Active Comparator | Conventional physical therapy. |
|
| Operators | No Intervention | Operators will evaluate systems usability during interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental FES cycling | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in knee joint extensors peak torque (Newton-Meters) | Quadriceps muscle strength, measured by isokinetic dynamometry | Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation |
| Change in knee joint flexors peak torque (Newton-Meters) | Quadriceps muscle strength, measured by isokinetic dynamometry | Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation |
| Change in thigh perimeter (centimeters) | Quadriceps muscle integrity, measured by thigh volumetry | Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation |
| Change in rectus femoris thickness (centimeters) | Rectus femoris muscle structural integrity, measured by ultrasound | Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation |
| Change in vastus intermedius thickness (centimeters) | Vastus intermedius muscle structural integrity, measured by ultrasound | Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Score | Systems usability, measured by self-referred survey (0-100, the higher the score, the better the outcome) | System usability at end of intervention, completed 8 weeks after initiation |
| Patients Perception of Treatment Outcomes Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| André T. Sugawara, MD, PhD | Contact | 55-11-5180-7897 | andre.sugawara@hc.fm.usp.br | |
| Vinicius D. Ramos | Contact | 55-11-5180-7897 | vinicius.ramos@hc.fm.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Linamara R. Battistella, MD, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina FÃsica e Reabilitação, Hospital das ClÃnicas, Faculdade de Medicina da Universidade de São Paulo | São Paulo | São Paulo | 04116-030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18191684 | Result | 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. | |
| 10816184 |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D001930 | Brain Injuries |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Parallel Assignment
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|
| Comparator FES cycling | Device | 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 | Other | Conventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks). |
|
Satisfaction, measured by self-referred survey (6-30, the higher the score, the better the outcome) |
| Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation |
| Adverse effects inventory | Qualitative evaluation of adverse effects, if any | Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation |
| Result |
| 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. |
| 16040545 | Result | 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. |
| 17855814 | Result | 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. |
| 12472328 | Result | 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. |
| 18511703 | Result | 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. |
| 16040540 | Result | 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. |
| 19893999 | Result | 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. |
| 16215380 | Result | 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. |
| 15699838 | Result | 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. |
| 8324411 | Result | 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. |
| 23917769 | Result | 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. |
| 20333769 | Result | 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. |
| D014947 | Wounds and Injuries |
| D001927 | Brain Diseases |
| D006259 | Craniocerebral Trauma |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |