Muscle and Bone Changes After 6 Months of FES Cycling

Spinal Cord Injuries Clinical Trial

— FES-Bike  

Official title:

Preliminary Evaluation of the Effectiveness of FES Cycling in Terms of Training Performance, Morpho-functional Characteristics of the Leg Muscles and Bone Trophism After 6 Months of Training in Spinal Cord Injury Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06321172
• Other study ID #: 785
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: April 29, 2024

Study information

• Verified date: March 2024
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles, training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training. The main question[s] it aims to answer are:

• Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling? If any, the morpho-functional improvements are maintained one month after the end of the training?

• Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling?

• Does the training performance improve during the training with FES cycling?

• Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling? If yes, the changes in the vegetative nervous system are maintained one month after the end of the training?

• Does the intestinal function change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?

• Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?

• Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?

• Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?

• Does the pilots' motivation in carrying out a sporting activity change between T1 (3 months after starting the training) and T2(6 months after starting the training)?

Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation.

Description:

Six months of FES-cycling trainings twice a week is performed for each pilot. Each session includes at most 30 minutes of stimulation.

At the beginning of training period, a conditioning phase is performed until the pilot reaches pedalling autonomy. This period is also used to define the stimulation parameters (minimum and maximum values of current intensity and pulse width), reference cadence and gear, specific for the ability of each pilot. Then the training period start and is performed indoor, setting the resistance of the smart trainer at 10% for all the participants. The sessions are organized as follows: a 3-minute warmup followed by four sets of 6 minutes of pedalling and a 3-minute cool down.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: April 29, 2024
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age of subjects between 18 and 65 years.

• Subjects with paraplegia resulting from a SCI with both traumatic and non-traumatic origins occurred less than 5 years before the start of the study.

• Complete loss of motor function in the lower limbs (level = T3, American Spinal Injury Association (ASIA) scale A or B)

• Adequate control of the trunk and sufficient muscle contraction using FES with surface electrodes.

• Preference for subjects with an aptitude for sports practice.

• Absence of a level of spasticity preventing device use and of disabling pain during training

Exclusion Criteria:

• Critical osteoporosis

• Skin lesions in interfaces parts with the trike,

• Dysfunction of the autonomic nervous system, and

• Psychopathological comorbidities

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• FES Bike
Six months of FES-cycling trainings twice a week is performed for each pilot. Each session includes at most 30 minutes of stimulation. At the beginning of the training period, a conditioning phase is performed until the pilot reaches pedalling autonomy. This period is also used to define the stimulation parameters (minimum and maximum values of current intensity and pulse width), reference cadence and gear, specific for the ability of each pilot. Then the training period starts and is performed indoor, setting the resistance of the smart trainer at 10% for all the participants. The sessions are organized as follows: a 3-minute warmup followed by four sets of 6 minutes of pedalling and a 3-minute cool down.

Locations

Country	Name	City	State
Italy	Scientific Institute, IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (4)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea	National Research Council, Politecnico di Milano, Villa Beretta Rehabilitation Center

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb	The primary outcome is the changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, which is investigated with the Magnetic Resonance Imaging (MRI) with multiparametric investigation methods.	After 6 months of training
Secondary	Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb	The primary outcome is the changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, which is investigated with the Magnetic Resonance Imaging (MRI) with multiparametric investigation methods.	After 3 months of training
Secondary	Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb	The primary outcome is the changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, which is investigated with the Magnetic Resonance Imaging (MRI) with multiparametric investigation methods.	One month after the end of the training
Secondary	Changes in bone quality	The evaluation of improvements in the quality of the leg bones is performed with the Bone Mineral Density (BMD)	After 6 months of training
Secondary	Changes in data referring to the vegetative nervous system	The evaluation of vegetative nervous system includes a series of test: at the beginning a rest test, then a standing test and a stepping test using a step automatic induction system (Erigo, Hocoma) and finally a cycling test (LAMBDA). For all these tests, heart rate (HR), systolic and diastolic blood pressure (sBP and dBP) and total peripheral resistance index (TPRI) are recorded.	After 3 months of training
Secondary	Changes in data referring to the vegetative nervous system	The evaluation of vegetative nervous system includes a series of test: at the beginning a rest test, then a standing test and a stepping test using a step automatic induction system (Erigo, Hocoma) and finally a cycling test (LAMBDA). For all these tests, heart rate (HR), systolic and diastolic blood pressure (sBP and dBP) and total peripheral resistance index (TPRI) are recorded.	After 6 months of training
Secondary	Changes in data referring to the vegetative nervous system	The evaluation of vegetative nervous system includes a series of test: at the beginning a rest test, then a standing test and a stepping test using a step automatic induction system (Erigo, Hocoma) and finally a cycling test (LAMBDA). For all these tests, heart rate (HR), systolic and diastolic blood pressure (sBP and dBP) and total peripheral resistance index (TPRI) are recorded.	One month after the end of the training
Secondary	Changes in the intestinal function	Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.	After 3 months of training
Secondary	Changes in the intestinal function	Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.	After 6 months of training
Secondary	Changes in the intestinal function	Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.	One month after the end of the training
Secondary	Changes in the level of spasticity of the lower limbs	To determine the level of spasticity in the lower limbs the Modified Ashworth scale (MAS) is used.	After 3 months of training
Secondary	Changes in the level of spasticity of the lower limbs	To determine the level of spasticity in the lower limbs the Modified Ashworth scale (MAS) is used.	After 6 months of training
Secondary	Changes in the level of spasticity of the lower limbs	To determine the level of spasticity in the lower limbs the Modified Ashworth scale (MAS) is used.	One month after the end of the training
Secondary	Changes in the level of pain perceived	Numerical Rating Scale (NRS) to quantify the level of pain perceived by the subject.	After 3 months of training
Secondary	Changes in the level of pain perceived	Numerical Rating Scale (NRS) to quantify the level of pain perceived by the subject.	After 6 months of training
Secondary	Changes in the level of pain perceived	Numerical Rating Scale (NRS) to quantify the level of pain perceived by the subject.	One month after the end of the training
Secondary	Changes in the General Well Being of the pilots while training	Psychological General Well-Being Index (PGWBI) is used to evaluate any repercussions that continuous FES-cycling activity has carried out on the well-being of the participants.	After 3 months of training
Secondary	Changes in the General Well Being of the pilots while training	Psychological General Well-Being Index (PGWBI) is used to evaluate any repercussions that continuous FES-cycling activity has carried out on the well-being of the participants.	After 6 months of training
Secondary	Changes in the General Well Being of the pilots while training	Psychological General Well-Being Index (PGWBI) is used to evaluate any repercussions that continuous FES-cycling activity has carried out on the well-being of the participants.	One month after the end of the training
Secondary	Pilots' motivation in carrying out a sporting activity	Sport Motivation Scale questionnaire is administered to evaluate the drivers' motivation in carrying out a sporting activity.	After 3 months of training
Secondary	Pilots' motivation in carrying out a sporting activity	Sport Motivation Scale questionnaire is administered to evaluate the drivers' motivation in carrying out a sporting activity.	After 6 months of training