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

Sponsors

Lead Sponsor: Universitat Internacional de Catalunya

Source 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.

Overall Status Not yet recruiting
Start Date 2021-04-29
Completion Date 2023-04-29
Primary Completion Date 2022-04-29
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Gait Performance T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Functional Lower Extremity Force T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Secondary Outcome
Measure Time Frame
Active Range of Movement (AROM) of the anckle T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
AROM of the knee T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Global Improvement Baseline up 30 min after treatment
Enrollment 36
Condition
Intervention

Intervention Type: Device

Intervention Name: CRet

Description: 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.

Arm Group Label: CRet Group

Intervention Type: Device

Intervention Name: Sham CRet

Description: 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.

Arm Group Label: CRet Sham Group

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Rosa Cabanas-Valdés, PhD Principal Investigator Universitat Internacional de Catalunya
Overall Contact

Last Name: Laura G García-Rueda, MSc

Phone: +34935042000

Email: [email protected]

Location
Facility: Universitat Internacional de Catalunya
Location Countries

Spain

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universitat Internacional de Catalunya

Investigator Full Name: Laura García Rueda

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CRet Group

Type: Experimental

Description: 30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis

Label: CRet Sham Group

Type: Sham Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

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