Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

Not Applicable

Not yet recruiting

• Conditions: Brain Injuries; Spinal Cord Injuries; Muscle Atrophy
• Interventions: Device: Experimental FES cycling; Other: Conventional physical therapy; Device: Comparator FES cycling

• Registration Number: NCT05888714
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-24
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-24
• Last Update Submitted: 2023-05-24
• Study Start: 2023-06-01
• Study First Posted: 2023-06-05
• Last Update Posted: 2023-06-05
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental FES cycling	Experimental FES cycling	New medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling)
Conventional physical therapy	Conventional physical therapy	Conventional physical therapy.
Comparator FES cycling	Comparator FES cycling	Existing medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling)

Primary Outcome Measures

Name	Time	Method
Change in knee joint extensors peak torque (Newton-Meters)	Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation	Quadriceps muscle strength, measured by isokinetic dynamometry
Change in knee joint flexors peak torque (Newton-Meters)	Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation	Quadriceps muscle strength, measured by isokinetic dynamometry
Change in thigh perimeter (centimeters)	Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation	Quadriceps muscle integrity, measured by thigh volumetry
Change in rectus femoris thickness (centimeters)	Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation	Rectus femoris muscle structural integrity, measured by ultrasound
Change in vastus intermedius thickness (centimeters)	Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation	Vastus intermedius muscle structural integrity, measured by ultrasound

Secondary Outcome Measures

Name	Time	Method
System Usability Score	System usability at end of intervention, completed 8 weeks after initiation	Systems usability, measured by self-referred survey (0-100, the higher the score, the better the outcome)
Patients Perception of Treatment Outcomes Score	Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation	Satisfaction, measured by self-referred survey (6-30, the higher the score, the better the outcome)
Adverse effects inventory	Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation	Qualitative evaluation of adverse effects, if any

Trial Locations

Locations (1)

Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil