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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04851756
Other study ID # CRet2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 29, 2021
Est. completion date September 5, 2022

Study information

Verified date April 2023
Source Universitat Internacional de Catalunya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 5, 2022
Est. primary completion date May 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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.
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.

Locations

Country Name City State
Spain Assessment Room at UIC Sant Cugat Sant Cugat Del Vallès Catalonia

Sponsors (1)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (22)

Barra-López M.E, Castillo-Tomás S, González-Rueda V, Villar-Mateo E, N. Domene- Guinart N y López-de-Celis C. Efectividad del masaje funcional en el síndrome de impingement subacromial. Fisioterapia 2015; 37 (2): 75

Bloem AEM, Veltkamp M, Spruit MA, Custers JWH, Bakker EWP, Dolk HM, Grutters JC. Validation of 4-meter-gait-speed test and 5-repetitions-sit-to-stand test in patients with pulmonary fibrosis: a clinimetric validation study. Sarcoidosis Vasc Diffuse Lung Dis. 2018;35(4):317-326. doi: 10.36141/svdld.v35i4.7035. Epub 2020 Mar 9. — View Citation

Clanton TO, Matheny LM, Jarvis HC, Jeronimus AB. Return to play in athletes following ankle injuries. Sports Health. 2012 Nov;4(6):471-4. doi: 10.1177/1941738112463347. — View Citation

Clijsen R, Leoni D, Schneebeli A, Cescon C, Soldini E, Li L, Barbero M. Does the Application of Tecar Therapy Affect Temperature and Perfusion of Skin and Muscle Microcirculation? A Pilot Feasibility Study on Healthy Subjects. J Altern Complement Med. 2020 Feb;26(2):147-153. doi: 10.1089/acm.2019.0165. Epub 2019 Oct 3. — View Citation

Coccetta CA, Sale P, Ferrara PE, Specchia A, Maccauro G, Ferriero G, Ronconi G. Effects of capacitive and resistive electric transfer therapy in patients with knee osteoarthritis: a randomized controlled trial. Int J Rehabil Res. 2019 Jun;42(2):106-111. doi: 10.1097/MRR.0000000000000324. — View Citation

Dobkin BH, Firestine A, West M, Saremi K, Woods R. Ankle dorsiflexion as an fMRI paradigm to assay motor control for walking during rehabilitation. Neuroimage. 2004 Sep;23(1):370-81. doi: 10.1016/j.neuroimage.2004.06.008. — View Citation

Gracies JM. Pathophysiology of spastic paresis. I: Paresis and soft tissue changes. Muscle Nerve. 2005 May;31(5):535-51. doi: 10.1002/mus.20284. — View Citation

Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285. — View Citation

H. Bingöl, Ö. Yilmaz. Effects of functional massage on spasticity and motor functions in children with cerebral palsy: a randomized controlled study. Journal of Exercise Therapy and Rehabilitation. 2018; 5:135-142.

Lopez-de-Celis C, Hidalgo-Garcia C, Perez-Bellmunt A, Fanlo-Mazas P, Gonzalez-Rueda V, Tricas-Moreno JM, Ortiz S, Rodriguez-Sanz J. Thermal and non-thermal effects off capacitive-resistive electric transfer application on the Achilles tendon and musculotendinous junction of the gastrocnemius muscle: a cadaveric study. BMC Musculoskelet Disord. 2020 Jan 20;21(1):46. doi: 10.1186/s12891-020-3072-4. — View Citation

Osti R, Pari C, Salvatori G, Massari L. Tri-length laser therapy associated to tecar therapy in the treatment of low-back pain in adults: a preliminary report of a prospective case series. Lasers Med Sci. 2015 Jan;30(1):407-12. doi: 10.1007/s10103-014-1684-3. Epub 2014 Nov 7. — View Citation

Pandyan AD, Gregoric M, Barnes MP, Wood D, Van Wijck F, Burridge J, Hermens H, Johnson GR. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil. 2005 Jan 7-21;27(1-2):2-6. doi: 10.1080/09638280400014576. No abstract available. — View Citation

Perez-Bellmunt A, Simon M, Lopez-de-Celis C, Ortiz-Miguel S, Gonzalez-Rueda V, Fernandez-de-Las-Penas C. Effects on Neuromuscular Function After Ischemic Compression in Latent Trigger Points in the Gastrocnemius Muscles: A Randomized Within-Participant Clinical Trial. J Manipulative Physiol Ther. 2022 Sep;45(7):490-496. doi: 10.1016/j.jmpt.2020.07.015. Epub 2021 Jan 9. — View Citation

Rech KD, Salazar AP, Marchese RR, Schifino G, Cimolin V, Pagnussat AS. Fugl-Meyer Assessment Scores Are Related With Kinematic Measures in People with Chronic Hemiparesis after Stroke. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104463. doi: 10.1016/j.jstrokecerebrovasdis.2019.104463. Epub 2019 Nov 15. — View Citation

Rikli R, Jones C, Functional fitness normative scores for community-residing older adults, ages 60-94. J Aging Phys Activity 1999;7(2):162-81.

Sainz-Pelayo MP, Albu S, Murillo N, Benito-Penalva J. [Spasticity in neurological pathologies. An update on the pathophysiological mechanisms, advances in diagnosis and treatment]. Rev Neurol. 2020 Jun 16;70(12):453-460. doi: 10.33588/rn.7012.2019474. Spanish. — View Citation

Scrivener K, Schurr K, Sherrington C. Responsiveness of the ten-metre walk test, Step Test and Motor Assessment Scale in inpatient care after stroke. BMC Neurol. 2014 Jun 16;14:129. doi: 10.1186/1471-2377-14-129. — View Citation

Tricás JM. Cuadernillos Prácticos de Fisioterapia, Masaje Funcional. Zaragoza: Fundación Empresa Universidad de Zaragoza. 2001;4.

Wang Y, Mukaino M, Ohtsuka K, Otaka Y, Tanikawa H, Matsuda F, Tsuchiyama K, Yamada J, Saitoh E. Gait characteristics of post-stroke hemiparetic patients with different walking speeds. Int J Rehabil Res. 2020 Mar;43(1):69-75. doi: 10.1097/MRR.0000000000000391. — View Citation

Wissel J, Verrier M, Simpson DM, Charles D, Guinto P, Papapetropoulos S, Sunnerhagen KS. Post-stroke spasticity: predictors of early development and considerations for therapeutic intervention. PM R. 2015 Jan;7(1):60-7. doi: 10.1016/j.pmrj.2014.08.946. Epub 2014 Aug 27. — View Citation

Yokota, Y., Tashiro, Y., Suzuki, Y., Tasaka, S., et al. (2017). Effect of capacitive and resistive electric transfer on tissue temperature, muscle flexibility, and blood circulation. J. Nov. Physiother. 7:325.

Zorowitz RD, Gillard PJ, Brainin M. Poststroke spasticity: sequelae and burden on stroke survivors and caregivers. Neurology. 2013 Jan 15;80(3 Suppl 2):S45-52. doi: 10.1212/WNL.0b013e3182764c86. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Gait Performance 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. T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Primary Functional Lower Extremity Force 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. T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Secondary Active Range of Movement (AROM) of the anckle 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. T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Secondary AROM of the knee 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. T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Secondary Global Improvement Global Improvement on two 5 points Likert Scale questions:
(1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.
Baseline up 30 min after treatment
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