search
Back to results

Effect of Tecar in Addition of Functional Massage in Post-stroke Spasticity (Tecar)

Primary Purpose

Stroke Sequelae, Massage, Spasticity, Muscle

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Tecar Therapy
Sham Tecar Therapy
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Sequelae focused on measuring Stroke, Spasticity, Tecar therapy, Functional massage, Muscle tone, Capacitive Resistive Electric Transfer Therapy (CRet)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Universitat Internacional de Catalunya
  • Laura Garcia Rueda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Control group

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Muscle flexibility
Myoton-Pro device applied on the muscle belly of rectus femoris, internal and external gastrocnemius
Muscle relaxation
Myoton-Pro device applied on the muscle belly of rectus femoris, internal and external gastrocnemius
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.

Full Information

First Posted
March 27, 2021
Last Updated
March 28, 2023
Sponsor
Universitat Internacional de Catalunya
search

1. Study Identification

Unique Protocol Identification Number
NCT04824768
Brief Title
Effect of Tecar in Addition of Functional Massage in Post-stroke Spasticity
Acronym
Tecar
Official Title
Immediate Effects of Tecar Therapy on Spasticity and Functionality of the Lower Limb in Chronic Post-stroke Survivors.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
May 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae, Massage, Spasticity, Muscle, Electrotherapy
Keywords
Stroke, Spasticity, Tecar therapy, Functional massage, Muscle tone, Capacitive Resistive Electric Transfer Therapy (CRet)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking 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 (0W). Functional Massage was then performed on the gastrocnemius, with Tecar in resistive mode (0W), and then in capacitive mode (0VA).
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Tecar Therapy
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham Tecar Therapy
Intervention 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 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
Primary Outcome Measure Information:
Title
Muscle tone
Description
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.
Time Frame
T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Secondary Outcome Measure Information:
Title
Muscle stiffness
Description
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.
Time Frame
T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Title
Muscle flexibility
Description
Myoton-Pro device applied on the muscle belly of rectus femoris, internal and external gastrocnemius
Time Frame
T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Title
Muscle relaxation
Description
Myoton-Pro device applied on the muscle belly of rectus femoris, internal and external gastrocnemius
Time Frame
T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Title
Passive range of motion
Description
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.
Time Frame
T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa C Cabanas-Valdés, PhD
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08195
Country
Spain
Facility Name
Laura Garcia Rueda
City
Barcelona
ZIP/Postal Code
08440
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22984012
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.
Results Reference
background
PubMed Identifier
26415945
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.
Results Reference
background
PubMed Identifier
31959172
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.
Results Reference
background
PubMed Identifier
31580698
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.
Results Reference
background
PubMed Identifier
32909988
Citation
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.
Results Reference
background
PubMed Identifier
23090951
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.
Results Reference
result
PubMed Identifier
25530960
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.
Results Reference
result
PubMed Identifier
23319485
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.
Results Reference
result
PubMed Identifier
7192811
Citation
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.
Results Reference
result
PubMed Identifier
19083678
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.
Results Reference
result
PubMed Identifier
14506719
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.
Results Reference
result
Citation
Kuo C, Hu G. Post-stroke spasticity: A review of epidemiology, pathophysiology, and treatments. International Journal of Gerontology. 2018;12(4):280-284.
Results Reference
result
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.
Results Reference
result

Learn more about this trial

Effect of Tecar in Addition of Functional Massage in Post-stroke Spasticity

We'll reach out to this number within 24 hrs