NCT04851756

Effects of CRet Associated With Functional Massage (F.M) on Gait and Functionality in Post-stroke Spasticity

Immediate Effect of Capacitive Resistive Electric Transfer Therapy (CRet) Associated With Functional Massage on the Rectus Femoris and Gastrocnemius in Post-stroke Spasticity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the immediate effects of CRet associated to Functional Massage (F.M) in terms of gait and functionality after stroke

Detailed description

Spasticity is a sensory motor disturbance as a result of a damage in the upper motoneuron, showing as an involuntary, intermittent and sustained activation of muscles. It is the most common feature after stroke, which most affects motor and functional recovery. Spasticity prevalence runs from 25% to 46% after the first six months post-stroke, and it is estimated that 16% will require treatment. Spasticity has neural (increased reflex activity) and biomechanical (altered viscoelastic properties due to immobilization) components. The initial paralysis after stroke modifies the bio mechanical properties of the muscle, thus shortening its fibers and causing an increase of velocity-dependent reflexes in the affected area. Spasticity manifests with paresis, increased muscle tone, muscular hyperactivity, decreased range of movement and pain. Gait disorder is one of the main physical limitations in stroke survivors and an important target for stroke rehabilitation, since physiotherapy treatments of spasticity aim to decrease excessive muscular tone, ease mobility, give the patient the sense of right position and avoid joint limitations. Functional Massage (F.M) is a non-invasive manual therapy technique that combines rhythmical passive mobilizations of the joints with gentle massage and compression of the muscles to be treated. As massage therapy is effective to improve spastic muscles and gross motor functions, F.M may be appropriate in treating post stroke spasticity and gait function. No studies were found on its effectiveness in patients with post-stroke spasticity. Capacitive Resistive electric transfer therapy (CRet) is a non-invasive diathermy technique that, providing high frequency energy (300KHz-1.2MHz),generates a thermal effect on soft tissues. CRet is used to facilitate tissue regeneration, and it does not need a surface-cooling system as its wave frequency is lower than in conservative diathermy. Its effectiveness has been evaluated in several studies related to musculoskeletal disorders, where an increase in temperature is needed in deep tissues in order to generate changes on its viscoelasticity. This effect may be beneficial in the spasticity treatment since spasticity onset and development may be affected by structural changes in muscular and tendinous fibers, as well as in its intra and extracellular components. No studies on the effects of CRet in post-stroke spasticity treatment were found.

Conditions

• Stroke Sequelae
• Spasticity, Muscle
• Massage
• Electrotherapy

Interventions

Type	Name	Description
DEVICE	CRet	In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (80-100W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (100-120 W) on the hamstrings. Then a 5 min Functional Massage (F.M) with passive anckle dorsiflexion and CRet on resistive mode (110-120 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min F.M with CRet on capacitive mode (180-250VA) on the mentioned area. In supine position, a 5 min F.M with passive knee flexion and CRet on resistive mode (110-140W) will be performed on the rectus femoris, followed by a 4 min F.M with passive knee flexion and CRet on capacitive mode (180-250VA) on the mentioned area. A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes.
DEVICE	Sham CRet	In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (0 W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (0 W) on the hamstrings. Then a 5 min Functional Massage (F.M) with passive anckle dorsiflexion and CRet on resistive mode (0 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min FM with CRet on capacitive mode (0 VA) on the mentioned area. In supine position, a 5 min F.M with passive knee flexion and CRet on resistive mode (0W) will be performed on the rectus femoris, followed by a 4 min F.M with passive knee flexion and CRet on capacitive mode (0VA) on the mentioned area. A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes.

Timeline

• Start date: 2021-04-29
• Primary completion: 2022-05-27
• Completion: 2022-09-05
• First posted: 2021-04-20
• Last updated: 2023-04-26

Locations

1 site across 1 country: Spain