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

Not Applicable

Completed

• Conditions: Massage; Electrotherapy; Stroke Sequelae; Spasticity, Muscle
• Interventions: Device: CRet; Device: Sham CRet

• Registration Number: NCT04851756
• Lead Sponsor: Universitat Internacional de Catalunya

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.

Study Timeline

• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-17
• Study First Posted: 2021-04-20
• Study Start: 2021-04-29
• Primary Completion: 2022-05-27
• Study Completion: 2022-09-05
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRet Group	CRet	30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis
CRet Sham Group	Sham CRet	30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis with turned on CRet device at power 0

Primary Outcome Measures

Name	Time	Method
Gait Performance	T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]	To evaluate change in gait speed after one session with CRet associated to F.M by the 4-metre-walk-test (4MWT). The assessor will indicate the participant to walk 4m at her fastest velocity. The timing will ve recorded.
Functional Lower Extremity Force	T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]	To evaluate change in functional lower extremity force after one session with CRet associated to F.M by the 5 times sit-to-stand test. Participants will be in the seating position on the treatment bed, and will stand and sit for five times. Time will start when the tester says 'go'.Time will stop when the participant's body touches the chair following the fifth repetition.

Secondary Outcome Measures

Name	Time	Method
Active Range of Movement (AROM) of the anckle	T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]	Measuring change of the maximum range of active dorsiflexion with an inclinometer by the dorsiflexion lunge test. The participant will be standing and holding on a wall. The tester will ask the participant to bend her ankle to her maximum range without lifting her heel from the floor.
AROM of the knee	T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]	Measuring change of the maximum range of active knee flexion on three point ( 0= no knee flexion, 1= knee does not reach = or \< 90 degrees, 2= knee flexion \>90 ) Fugl Meyer Assessment. Only the lower extremity item of the Fugl Meyer assessment will be used in this study.
Global Improvement	Baseline up 30 min after treatment	Global Improvement on two 5 points Likert Scale questions: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.

Trial Locations

Locations (1)

Assessment Room at UIC Sant Cugat; 🇪🇸 Sant Cugat Del Vallès, Catalonia, Spain