Spasticity, Muscle Clinical Trial
— TecarOfficial title:
Immediate Effects of Tecar Therapy on Spasticity and Functionality of the Lower Limb in Chronic Post-stroke Survivors.
NCT number | NCT04824768 |
Other study ID # | CRet 1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 20, 2021 |
Est. completion date | May 26, 2022 |
Verified date | March 2023 |
Source | Universitat Internacional de Catalunya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Spasticity is due to an abnormal processing of a normal input from muscle spindles in the spinal cord.
Status | Completed |
Enrollment | 36 |
Est. completion date | May 26, 2022 |
Est. primary completion date | April 29, 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 or/and knee flexion or/and ankle dorsiflexion on the most affected limb - Scoring 25 or plus on the Montreal Cognitive Assessment (MoCA) Exclusion Criteria: - 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 - 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) |
Country | Name | City | State |
---|---|---|---|
Spain | Laura Garcia Rueda | Barcelona | |
Spain | Universitat Internacional de Catalunya | Barcelona | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Universitat Internacional de Catalunya |
Spain,
Beltrame 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. — View Citation
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.
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
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. — View Citation
Gillard 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. — View Citation
Kuo C, Hu G. Post-stroke spasticity: A review of epidemiology, pathophysiology, and treatments. International Journal of Gerontology. 2018;12(4):280-284.
Lance 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. — View Citation
Lieber 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. — View Citation
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
Rehme 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. — View Citation
Stecco 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. — View Citation
Trompetto 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. — View Citation
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 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment | |
Secondary | 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. | T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment | |
Secondary | Muscle flexibility | Myoton-Pro device applied on the muscle belly of rectus femoris, internal and external gastrocnemius | T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment | |
Secondary | Muscle relaxation | Myoton-Pro device applied on the muscle belly of rectus femoris, internal and external gastrocnemius | T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment | |
Secondary | 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. | T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment |
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