Clinical trial NCT04851756: Effects of CRet Associated With Functional Massage (F.M) on Gait and Functionality in Post-stroke Spasticity
Official title: Immediate Effect of Capacitive Resistive Electric Transfer Therapy (CRet) Associated With Functional Massage on the Rectus Femoris and Gastrocnemius in Post-stroke Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Spasticity, Muscle
Massage
Electrotherapy
Keywords: Stroke
Spasticity
Functional Massage
CRet
Functionality
Gait
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stroke
* Scoring 1+ on the Modified Ashworth Scale (MAS) for hip flexion and/or knee flexion or/and ancke dorsiflexion on the most affected limb
* Scoring 25 or plus on the Montreal Cognitive Assessment (MoCA)
* Signing the informed consent form

Exclusion Criteria:

* Having suffered a traumatism on the lower limbs three months, or less, before the intervention
* Other neurological diseases
* Presence of osteosynthetic material
* Pacemaker wearing
* Treatment with botulinum toxin or another antispastic medication, six months , or less, before the intervention
* Carry baclofen pump
* Functional inability to adopt the prone or supine position on the treatment table
* Functional inability to sit, stand and walk
* Poor language and communication skills that make difficult to understand the informed consent form
* Contraindications to Functional Massage (infectious diseases, inflammatory vascular conditions, acute inflammation, haemorrhagia, fever)

Primary outcomes:
measure: Gait Performance
timeFrame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
measure: Functional Lower Extremity Force
timeFrame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Secondary outcomes:
measure: Active Range of Movement (AROM) of the anckle
timeFrame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
measure: AROM of the knee
timeFrame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
measure: Global Improvement
timeFrame: Baseline up 30 min after treatment
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Assessment Room at UIC Sant Cugat
state: Catalonia
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Rosa Cabanas-Valdés, PhD
role: PRINCIPAL_INVESTIGATOR
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