Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

Spinal Cord Injuries Clinical Trial

Official title:

Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle: Healthy or Deprived of Central Nervous System Control

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05888714
• Other study ID #: CAAE 64324122.0.0000.0068
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Sao Paulo General Hospital
• Contact: André T. Sugawara, MD, PhD
• Phone: 55-11-5180-7897
• Email: andre.sugawara[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Spinal cord injury, brain injury or acquired muscle weakness

• Managed chronic diseases

• No contraindications to the practice of physical exercise

• Ability to communicate in oral and written Portuguese

Exclusion Criteria:

• Amputation of lower limbs at any level

• Unstable or acute fractures of lower limbs

• Contraindication for the practice of physical activity

• Open wounds in the lower limbs

• Consent withdraw

Related Conditions & MeSH terms

• Brain Injuries
• Muscle Atrophy
• Muscular Atrophy
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• 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.

Other:
• Conventional physical therapy
Conventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks).

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Agência Brasileira de Desenvolvimento Industrial (Brazilian Agency For Industrial Development)

Country where clinical trial is conducted

Brazil, 

References & Publications (13)

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 — View Citation

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 — View Citation

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 int — View Citation

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. — View Citation

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):349-5 — View Citation

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 pair — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Rehabi — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Patients Perception of Treatment Outcomes Score	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
Secondary	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