Stroke SequelaeNCT04851756
Effects of CRet Associated With Functional Massage (F.M) on Gait and Functionality in Post-stroke Spasticity
A study testing CRet in people with Stroke Sequelae and Spasticity, Muscle, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae, Spasticity, Muscle, Massage
- What is being tested?
- CRet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 29 Apr 2021to 5 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Assessment Room at UIC Sant Cugat
Sant Cugat del Vallès, Catalonia, 08195
About this study
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
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
Read the 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
- Being tested
- CRet, Sham CRet
- Keywords
- Stroke, Spasticity, Functional Massage, CRet, Functionality, Gait
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRetDevice
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 CRetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CRet Group | Experimental | 30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis Receives: Device: CRet |
| CRet Sham Group | Sham comparator | 30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis with turned on CRet device at power 0 Receives: Device: Sham CRet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
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.
Measured: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Secondary outcomes (3)
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.
Measured: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
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.
Measured: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
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.
Measured: Baseline up 30 min after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start29 Apr 2021
- Primary completion27 May 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura García Rueda, Universitat Internacional de Catalunya
- Investigators
- Rosa Cabanas-Valdés, PhD, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851756
- Sponsor's protocol ID
- CRet2
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15799140Zorowitz 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.
PubMed 23319485Sainz-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.
PubMed 32500524Wissel 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.
PubMed 25171879Gracies JM. Pathophysiology of spastic paresis. I: Paresis and soft tissue changes. Muscle Nerve. 2005 May;31(5):535-51. doi: 10.1002/mus.20284.
PubMed 15714510Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.
PubMed 15714511Wang 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.
PubMed 31855899Tricás JM. Cuadernillos Prácticos de Fisioterapia, Masaje Funcional. Zaragoza: Fundación Empresa Universidad de Zaragoza. 2001;4.
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
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.
PubMed 31580698Lopez-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.
PubMed 31959172H. Bingöl, Ö. Yılmaz. 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.
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.
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.
PubMed 25376670Coccetta 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.
PubMed 30362981
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04851756
- Acronym / sponsor ID
- CRet2
- Conditions
- Stroke Sequelae, Spasticity, Muscle, Massage, Electrotherapy
- Keywords
- Stroke, Spasticity, Functional Massage, CRet, Functionality, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRet Group | Experimental | Device: CRet30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis |
| CRet Sham Group | Sham comparator | Device: Sham CRet30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis with turned on CRet device at power 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRetIn 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 | CRet Group |
| Sham CRetIn 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. | Device | CRet Sham Group |
Primary outcome
Gait Performance
Time frame: 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
Time frame: 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.
3 secondary outcomes
Active Range of Movement (AROM) of the anckle
Time frame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
AROM of the knee
Time frame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Global Improvement
Time frame: Baseline up 30 min after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 15799140Pandyan 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.
- Background: PubMed 23319485Zorowitz 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.
- Background: PubMed 32500524Sainz-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.
- Background: PubMed 25171879Wissel 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.
- Background: PubMed 15714510Gracies JM. Pathophysiology of spastic paresis. I: Paresis and soft tissue changes. Muscle Nerve. 2005 May;31(5):535-51. doi: 10.1002/mus.20284.
- Background: PubMed 15714511Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.
- Background: PubMed 31855899Wang 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.
- BackgroundTricás JM. Cuadernillos Prácticos de Fisioterapia, Masaje Funcional. Zaragoza: Fundación Empresa Universidad de Zaragoza. 2001;4.
- BackgroundBarra-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
- Background: PubMed 31580698Clijsen 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.
- Background: PubMed 31959172Lopez-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.
- BackgroundH. Bingöl, Ö. Yılmaz. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Cabanas-Valdés, PhD principal investigator
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRet in people with Stroke Sequelae and Spasticity, Muscle, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Performance (time frame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851756, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.