Stroke SequelaeTecarNCT04824768
Effect of Tecar in Addition of Functional Massage in Post-stroke Spasticity
A study testing Tecar Therapy in people with Stroke Sequelae and Massage, run by Universitat Internacional de Catalunya at 2 sites in Spain.
Trial summary
Spasticity is due to an abnormal processing of a normal input from muscle spindles in the spinal cord. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae, Massage, Spasticity, Muscle
- What is being tested?
- Tecar Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesSpain
- Study dates
- 20 May 2021to 26 May 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 or/and knee flexion or/and ankle dorsiflexion on the most affected limb
- Scoring 25 or plus on the Montreal Cognitive Assessment (MoCA)
Who cannot join
- Having suffered a traumatism on the lower limbs three months, or less, before the intervention
- Suffer other neurological disease
- 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
- Contraindications to Functional Massage (infectious diseases, inflammatory vascular conditions, acute inflammation, hemorrhagic, fever)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universitat Internacional de Catalunya
Barcelona, Catalonia, 08195
Laura Garcia Rueda
Barcelona, 08440
About this study
Official title: Immediate Effects of Tecar Therapy on Spasticity and Functionality of the Lower Limb in Chronic Post-stroke Survivors.
Spasticity is due to an abnormal processing of a normal input from muscle spindles in the spinal cord.
Read the detailed description
Stroke often affects sensory-motor networks and descending tracts, as reflected by several signs of upper motor neuron syndrome. One symptom is post-stroke spasticity. It is due to an abnormal processing of a normal input from muscle spindles in the spinal cord. It is often defined by a velocity-dependent increase in muscle tone and a resistance to passive muscle stretch. It has neural (increased reflex activity) and non-neural (altered visco-elastic properties due to immobilization) components. The prevalence of spasticity ranges from 25%-43% at 6 months post-stroke. Chronic spasticity can decrease the number of sarcomeres. As a result, the proportion of connective tissue in the muscle and fasciae can increase. These subjects present fibrosis that have augmented passive muscle stiffness due to structural and functional adaptations inside the muscle cells. Soft tissue changes may cause the pulling forces to be transmitted more readily to the muscle spindles, which can intensify sensory input thus increasing spasticity. It has a potential impact on lower limb function, which affects passive muscle stretch, range of motion, and motor unit recruitment during voluntary contraction. In the stance phase of gait, the deformity also produces an inadequate base of support, which is associated with balance impairments. This increases the risk of falls, reduces patient participation in daily activities, and decreases health-related quality of life. 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 is a non-invasive manual therapy technique that combines rhythmical passive joint mobilization with compression and decompression of the muscular belly with the tendinomuscular insertions to treat. It is indicated in cases of muscle stiffness associated with pain.
Tecar therapy or Capacitive Resistive Electric Transfer Therapy (CRet) is a non-invasive diathermy technique which provides high frequency energy (300 KHz-1.2 MHz) generating 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. CRet effectiveness has been evaluated in several studies. It is effective in the treatment of chronic musculoskeletal disorders, where a temperature increase on deep tissues is needed 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.
No studies on the effects of CRet in post-stroke spasticity treatment were found.
- Conditions
- Stroke Sequelae, Massage, Spasticity, Muscle, Electrotherapy
- Being tested
- Tecar Therapy, Sham Tecar Therapy
- Keywords
- Stroke, Spasticity, Tecar therapy, Functional massage, Muscle tone, Capacitive Resistive Electric Transfer Therapy (CRet)
- 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.
Tecar TherapyDevice
CRet is a non-invasive diathermy technique that provides high frequency energy generating a thermal effect on soft tissues. Functional massage (FM) is a non-invasive manual therapy technique that combines rhythmical passive joint mobilization with compression of the muscular belly with the muscle-tendon insertions to be treated.
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 F.M with passive ankle dorsiflexion and CRet on resistive mode (110-120 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min FM with CRet on capacitive mode (180-250VA) on the mentioned area.
In supine position, a 5 min FM with passive knee flexion and CRet on resistive mode 8.
A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes
Sham Tecar TherapyDevice
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 FM with passive ankle 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 FM with passive knee flexion and CRet on resistive mode 0.
A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 30 min session of Tecar Therapy with functional massage on the rectus femoris, and gastrocnemius. Tecar therapy in the resistive modality (80W) on lower back and hamstrings and in rectus femoris and gastrocnemius with resistive mode (100-120W), and then in capacitive mode(180-200VA) Receives: Device: Tecar Therapy |
| Control group | Sham comparator | 30 min session of Tecar Therapy with functional massage on the rectus femoris, and gastrocnemius. Sham stimulation was provided by only turn on the device but dose is 0. Receives: Device: Sham Tecar Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tone
To evaluate the immediate changes in terms of muscle tone on the rectus femoris, medialis and gastrocnemius after one session with CRet as coadjuvant of functional massage by modified Ashworth Scale of Hip flexion-extension, knee flexion-extension, ankle plantar flexion and dorsiflexion. The minimum and maximum values are 0 and 4, higher scores mean a worse outcome.
Measured: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Secondary outcomes (4)
Muscle stiffness
To evaluate muscle stiffness on rectus femoris and gastrocnemius after one session with CRet as coadjuvant of functional massage by mioton Myoton Pro, Myoton Ltds., Estonia) on the muscular belly.
Measured: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Muscle flexibility
Myoton-Pro device applied on the muscle belly of rectus femoris, internal and external gastrocnemius
Measured: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Muscle relaxation
Myoton-Pro device applied on the muscle belly of rectus femoris, internal and external gastrocnemius
Measured: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Passive range of motion
Goniometry applied on passive hip flexion and extension, passive knee flexion and ankle plantar flexion and dorsiflexion with a wedge under the knees. The force applied by the physiotherapist will be recorded with a goniometer and will be applied to the head of the metatarsals.
Measured: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start20 May 2021
- Primary completion29 Apr 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Model description
- An introductory massage was performed on the lumbar region and hamstrings of the most affected leg, in conjunction with Tecar therapy in the resistive modality (80W). Functional Massage was then performed on the gastrocnemius, with Tecar in resistive mode (100-120W), and then in capacitive mode (180-200VA).
- 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, Rosa Cabanas Valdés, Universitat Internacional de Catalunya
- Investigators
- Rosa C Cabanas-Valdés, PhD, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824768
- Sponsor's protocol ID
- CRet 1
- Acronym
- Tecar
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Francisco GE, McGuire JR. Poststroke spasticity management. Stroke. 2012 Nov;43(11):3132-6. doi: 10.1161/STROKEAHA.111.639831. Epub 2012 Sep 13. No abstract available.
PubMed 22984012Gillard PJ, Sucharew H, Kleindorfer D, Belagaje S, Varon S, Alwell K, Moomaw CJ, Woo D, Khatri P, Flaherty ML, Adeoye O, Ferioli S, Kissela B. The negative impact of spasticity on the health-related quality of life of stroke survivors: a longitudinal cohort study. Health Qual Life Outcomes. 2015 Sep 29;13:159. doi: 10.1186/s12955-015-0340-3.
PubMed 26415945Lopez-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 31959172Clijsen 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 31580698Beltrame R, Ronconi G, Ferrara PE, Salgovic L, Vercelli S, Solaro C, Ferriero G. Capacitive and resistive electric transfer therapy in rehabilitation: a systematic review. Int J Rehabil Res. 2020 Dec;43(4):291-298. doi: 10.1097/MRR.0000000000000435.
PubMed 32909988Rehme AK, Grefkes C. Cerebral network disorders after stroke: evidence from imaging-based connectivity analyses of active and resting brain states in humans. J Physiol. 2013 Jan 1;591(1):17-31. doi: 10.1113/jphysiol.2012.243469. Epub 2012 Oct 22.
PubMed 23090951Trompetto C, Marinelli L, Mori L, Pelosin E, Curra A, Molfetta L, Abbruzzese G. Pathophysiology of spasticity: implications for neurorehabilitation. Biomed Res Int. 2014;2014:354906. doi: 10.1155/2014/354906. Epub 2014 Oct 30.
PubMed 25530960Zorowitz 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 23319485Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.
PubMed 7192811Stecco C, Porzionato A, Lancerotto L, Stecco A, Macchi V, Day JA, De Caro R. Histological study of the deep fasciae of the limbs. J Bodyw Mov Ther. 2008 Jul;12(3):225-30. doi: 10.1016/j.jbmt.2008.04.041. Epub 2008 Jun 13.
PubMed 19083678Lieber RL, Runesson E, Einarsson F, Friden J. Inferior mechanical properties of spastic muscle bundles due to hypertrophic but compromised extracellular matrix material. Muscle Nerve. 2003 Oct;28(4):464-71. doi: 10.1002/mus.10446.
PubMed 14506719Kuo C, Hu G. Post-stroke spasticity: A review of epidemiology, pathophysiology, and treatments. International Journal of Gerontology. 2018;12(4):280-284.
Cacho RdO, Cacho EWA, Loureiro AB, et al. The spasticity in the motor and functional disability in adults with post-stroke hemiparetic. Fisioterapia em Movimento. 2017;30(4):745-752.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Tecar Therapy on Spasticity and Functionality of the Lower Limb in Chronic Post-stroke Survivors.
- ClinicalTrials.gov ID
- NCT04824768
- Acronym / sponsor ID
- Tecar / CRet 1
- Conditions
- Stroke Sequelae, Massage, Spasticity, Muscle, Electrotherapy
- Keywords
- Stroke, Spasticity, Tecar therapy, Functional massage, Muscle tone, Capacitive Resistive Electric Transfer Therapy (CRet)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 1 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.
Spasticity is due to an abnormal processing of a normal input from muscle spindles in the spinal cord.
Detailed description
Stroke often affects sensory-motor networks and descending tracts, as reflected by several signs of upper motor neuron syndrome. One symptom is post-stroke spasticity. It is due to an abnormal processing of a normal input from muscle spindles in the spinal cord. It is often defined by a velocity-dependent increase in muscle tone and a resistance to passive muscle stretch. It has neural (increased reflex activity) and non-neural (altered visco-elastic properties due to immobilization) components. The prevalence of spasticity ranges from 25%-43% at 6 months post-stroke. Chronic spasticity can decrease the number of sarcomeres. As a result, the proportion of connective tissue in the muscle and fasciae can increase. These subjects present fibrosis that have augmented passive muscle stiffness due to structural and functional adaptations inside the muscle cells. Soft tissue changes may cause the pulling forces to be transmitted more readily to the muscle spindles, which can intensify sensory input thus increasing spasticity. It has a potential impact on lower limb function, which affects passive muscle stretch, range of motion, and motor unit recruitment during voluntary contraction. In the stance phase of gait, the deformity also produces an inadequate base of support, which is associated with balance impairments. This increases the risk of falls, reduces patient participation in daily activities, and decreases health-related quality of life. 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 is a non-invasive manual therapy technique that combines rhythmical passive joint mobilization with compression and decompression of the muscular belly with the tendinomuscular insertions to treat. It is indicated in cases of muscle stiffness associated with pain.
Tecar therapy or Capacitive Resistive Electric Transfer Therapy (CRet) is a non-invasive diathermy technique which provides high frequency energy (300 KHz-1.2 MHz) generating 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. CRet effectiveness has been evaluated in several studies. It is effective in the treatment of chronic musculoskeletal disorders, where a temperature increase on deep tissues is needed 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.
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
- Model description
- An introductory massage was performed on the lumbar region and hamstrings of the most affected leg, in conjunction with Tecar therapy in the resistive modality (80W). Functional Massage was then performed on the gastrocnemius, with Tecar in resistive mode (100-120W), and then in capacitive mode (180-200VA).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Tecar Therapy30 min session of Tecar Therapy with functional massage on the rectus femoris, and gastrocnemius. Tecar therapy in the resistive modality (80W) on lower back and hamstrings and in rectus femoris and gastrocnemius with resistive mode (100-120W), and then in capacitive mode(180-200VA) |
| Control group | Sham comparator | Device: Sham Tecar Therapy30 min session of Tecar Therapy with functional massage on the rectus femoris, and gastrocnemius. Sham stimulation was provided by only turn on the device but dose is 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Stroke
- Scoring 1 on the Modified Ashworth Scale (MAS) for hip or/and knee flexion or/and ankle dorsiflexion on the most affected limb
- Scoring 25 or plus on the Montreal Cognitive Assessment (MoCA)
Key exclusion criteria (10 listed)
- Having suffered a traumatism on the lower limbs three months, or less, before the intervention
- Suffer other neurological disease
- 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 |
|---|---|---|
| Tecar TherapyCRet is a non-invasive diathermy technique that provides high frequency energy generating a thermal effect on soft tissues. Functional massage (FM) is a non-invasive manual therapy technique that combines rhythmical passive joint mobilization with compression of the muscular belly with the muscle-tendon insertions to be treated. 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 F.M with passive ankle dorsiflexion and CRet on resistive mode (110-120 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min FM with CRet on capacitive mode (180-250VA) on the mentioned area. In supine position, a 5 min FM with passive knee flexion and CRet on resistive mode 8. A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes | Device | Experimental group |
| Sham Tecar TherapyIn 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 FM with passive ankle 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 FM with passive knee flexion and CRet on resistive mode 0. A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes | Device | Control group |
Primary outcome
Muscle tone
Time frame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
To evaluate the immediate changes in terms of muscle tone on the rectus femoris, medialis and gastrocnemius after one session with CRet as coadjuvant of functional massage by modified Ashworth Scale of Hip flexion-extension, knee flexion-extension, ankle plantar flexion and dorsiflexion. The minimum and maximum values are 0 and 4, higher scores mean a worse outcome.
4 secondary outcomes
Muscle stiffness
Time frame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Muscle flexibility
Time frame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Muscle relaxation
Time frame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Passive range of motion
Time frame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes 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 29 Mar 2023.
- Background: PubMed 22984012Francisco GE, McGuire JR. Poststroke spasticity management. Stroke. 2012 Nov;43(11):3132-6. doi: 10.1161/STROKEAHA.111.639831. Epub 2012 Sep 13. No abstract available.
- Background: PubMed 26415945Gillard PJ, Sucharew H, Kleindorfer D, Belagaje S, Varon S, Alwell K, Moomaw CJ, Woo D, Khatri P, Flaherty ML, Adeoye O, Ferioli S, Kissela B. The negative impact of spasticity on the health-related quality of life of stroke survivors: a longitudinal cohort study. Health Qual Life Outcomes. 2015 Sep 29;13:159. doi: 10.1186/s12955-015-0340-3.
- 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.
- 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 32909988Beltrame R, Ronconi G, Ferrara PE, Salgovic L, Vercelli S, Solaro C, Ferriero G. Capacitive and resistive electric transfer therapy in rehabilitation: a systematic review. Int J Rehabil Res. 2020 Dec;43(4):291-298. doi: 10.1097/MRR.0000000000000435.
- Results publication: PubMed 23090951Rehme AK, Grefkes C. Cerebral network disorders after stroke: evidence from imaging-based connectivity analyses of active and resting brain states in humans. J Physiol. 2013 Jan 1;591(1):17-31. doi: 10.1113/jphysiol.2012.243469. Epub 2012 Oct 22.
- Results publication: PubMed 25530960Trompetto C, Marinelli L, Mori L, Pelosin E, Curra A, Molfetta L, Abbruzzese G. Pathophysiology of spasticity: implications for neurorehabilitation. Biomed Res Int. 2014;2014:354906. doi: 10.1155/2014/354906. Epub 2014 Oct 30.
- Results publication: 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.
- Results publication: PubMed 7192811Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.
- Results publication: PubMed 19083678Stecco C, Porzionato A, Lancerotto L, Stecco A, Macchi V, Day JA, De Caro R. Histological study of the deep fasciae of the limbs. J Bodyw Mov Ther. 2008 Jul;12(3):225-30. doi: 10.1016/j.jbmt.2008.04.041. Epub 2008 Jun 13.
- Results publication: PubMed 14506719Lieber RL, Runesson E, Einarsson F, Friden J. Inferior mechanical properties of spastic muscle bundles due to hypertrophic but compromised extracellular matrix material. Muscle Nerve. 2003 Oct;28(4):464-71. doi: 10.1002/mus.10446.
- Results publicationKuo C, Hu G. Post-stroke spasticity: A review of epidemiology, pathophysiology, and treatments. International Journal of Gerontology. 2018;12(4):280-284.
- 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 C Cabanas-Valdés, PhD principal investigator
Universitat Internacional de Catalunya
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecar Therapy in people with Stroke Sequelae and Massage, run by Universitat Internacional de Catalunya at 2 sites 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 3 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Muscle tone (time frame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment). 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 NCT04824768, which also lists 13 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 29 Mar 2023.