search
Back to results

Effects of CRet Associated With Functional Massage (F.M) on Gait and Functionality in Post-stroke Spasticity

Primary Purpose

Stroke Sequelae, Spasticity, Muscle, Massage

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CRet
Sham CRet
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, Functional Massage, CRet, Functionality, Gait

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 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)

Sites / Locations

  • Assessment Room at UIC Sant Cugat

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CRet Group

CRet Sham Group

Arm Description

30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis

30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis with turned on CRet device at power 0

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 11, 2021
Last Updated
April 24, 2023
Sponsor
Universitat Internacional de Catalunya
search

1. Study Identification

Unique Protocol Identification Number
NCT04851756
Brief Title
Effects of CRet Associated With Functional Massage (F.M) on Gait and Functionality in Post-stroke Spasticity
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
September 5, 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
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Sequelae, Spasticity, Muscle, Massage, Electrotherapy
Keywords
Stroke, Spasticity, Functional Massage, CRet, Functionality, Gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRet Group
Arm Type
Experimental
Arm Description
30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis
Arm Title
CRet Sham Group
Arm Type
Sham Comparator
Arm Description
30 min CRet with F.M on the rectus femoris and gastrocnemius medialis and lateralis with turned on CRet device at power 0
Intervention Type
Device
Intervention Name(s)
CRet
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham CRet
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 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.
Primary Outcome Measure Information:
Title
Gait Performance
Description
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.
Time Frame
T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Title
Functional Lower Extremity Force
Description
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.
Time Frame
T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Secondary Outcome Measure Information:
Title
Active Range of Movement (AROM) of the anckle
Description
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.
Time Frame
T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Title
AROM of the knee
Description
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.
Time Frame
T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ]
Title
Global Improvement
Description
Global Improvement on two 5 points Likert Scale questions: (1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree.
Time Frame
Baseline up 30 min 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Cabanas-Valdés, PhD
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assessment Room at UIC Sant Cugat
City
Sant Cugat Del Vallès
State/Province
Catalonia
ZIP/Postal Code
08195
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15799140
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.
Results Reference
background
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
background
PubMed Identifier
32500524
Citation
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.
Results Reference
background
PubMed Identifier
25171879
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.
Results Reference
background
PubMed Identifier
15714510
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.
Results Reference
background
PubMed Identifier
15714511
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.
Results Reference
background
PubMed Identifier
31855899
Citation
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.
Results Reference
background
Citation
Tricás JM. Cuadernillos Prácticos de Fisioterapia, Masaje Funcional. Zaragoza: Fundación Empresa Universidad de Zaragoza. 2001;4.
Results Reference
background
Citation
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
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
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
Citation
H. 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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
25376670
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.
Results Reference
background
PubMed Identifier
30362981
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
32476919
Citation
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.
Results Reference
background
PubMed Identifier
24934859
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.
Results Reference
background
PubMed Identifier
24179584
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.
Results Reference
background
PubMed Identifier
15325385
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.
Results Reference
background
PubMed Identifier
31740027
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.
Results Reference
background
PubMed Identifier
33431281
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.
Results Reference
background

Learn more about this trial

Effects of CRet Associated With Functional Massage (F.M) on Gait and Functionality in Post-stroke Spasticity

We'll reach out to this number within 24 hrs