Functional Massage and Eccentric Exercise in Stroke Survivors (FM-EE Stroke)

NCT06922149 | Completed

• 1 other identifier: FM and EE stroke
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is currently the leading cause of mortality in women, the second in men and the leading cause of disability in older adults. One of the most challenging sequelae after stroke is increased muscle tone due to spasticity, which alters muscle function. Functional massage therapy focuses on enhancing the function of muscles, joints, and connective tissues to improve movement and reduce pain. On the other hand, eccentric exercise, aids in the recovery of physical functions and is effective in managing spasticity improving muscle coordination and flexibility. It is essential to underline that the strength of evidence regarding these effects is considerable, supporting the implementation of these exercises in post-stroke treatment. In this context, an intervention combining functional massage with eccentric exercise on the lower limb is proposed for stroke survivors in the chronic phase. The goal of this crossover study is to analyze the effects of functional massage combined with eccentric exercise versus eccentric exercise alone on the effects of muscle tone, due to spasticity, of the lower limb in patients with chronic stroke. The Secondary Objectives are to analyze the effects of functional massage combined with eccentric exercise versus eccentric exercise alone on the improvement of ROM of the hip, knee and ankle joints, gait speed, lower limb function, quality of life and reduction of stress, anxiety and depression in patients with chronic stroke. The number of patients to be treated will be 8, the numbers of visits per patient will be 8 at the facilities of the university. Functional massage is a manual therapy technique that combines rhythmic passive mobilization of the joint, together with compression and decompression of the musculature to be treated. Eccentric exercises on lower limb focuses on movements, or phases of a movement, that lengthen the muscles. Some examples of eccentric exercise include lowering into a squat or lowering into a press-up. However, there are few previous studies combining these approaches to reduce spasticity and muscle tone and improve functionality in post-stroke patients. Participation in this study carries minimal risk, which could include events such as ankle endorses or falls during gait speed assessment or during therapeutic exercise. To mitigate these risks, participants will be allowed to use assistive devices such as splints, ankle braces, canes, or crutches during the activities selected for intervention. Importantly, patients in the chronic phase of stroke, and not in the acute phase, are included due to the stability of their condition which allows for safer and more effective participation in the study.

Conditions

Stroke

Keywords

stroke, eccentric exercises, functional massage, muscle tone

Outcome Measures

Primary Outcomes (1)

• Muscle tone will be assessed by modified Ashworth scale and Myoton pro.

  Muscle tone (residual muscle tension or tonus) is the continuous and passive partial contraction of the muscles, or the muscle's resistance to passive stretch during resting state. It helps to maintain posture and declines during REM sleep.Muscle tone is regulated by the activity of the motor neurons and can be affected by various factors, including age, disease, and nerve damage as spasticity. Modified Ashworth scale is performed by extending the patients limb's first from a position of maximal flexion to maximal extension (the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. 0 is no increase in tone and 4 limb rigid in flexion or extension. The Myoton recording of dynamic tissue response in the form of physical displacement and oscillation acceleration signal and the subsequent computation of parameters characterizing the State of Tension, Biomechanical and Viscoelastic properties.

  Baseline and posttreatment at 4 weeks and at 8 weeks

Secondary Outcomes (5)

• Range of Motion (ROM) of the hip, knee and foot joints will be assessed by inclinometer.

  Baseline and posttreatment at 4 weeks and at 8 weeks

• Gait speed will be assessed by 4 meters walking test at confortable pace and maximum pace.

  Baseline and posttreatment at 4 weeks and at 8 weeks

• Functionality of lower limb will be assessed by 30 seconds sit-to-stand and lower limb Fugl meyer scale

  Baseline and posttreatment at 4 weeks and at 8 weeks

• Self-perceived emotional burden like stress, anxiety and depression will be assessed by Depression, Anxiety and Stress Scale-21 (DASS-21)

  Baseline and posttreatment at 4 weeks and at 8 weeks

• Quality of life and health status will be assessed by EuroQoL-5D-5L.

  Baseline and posttreatment at 4 weeks and at 8 weeks

Study Arms (2)

Group A Functional massage in addition to eccentric exercise in paretic lower limb

EXPERIMENTAL

Functional massage (FM) in addition to eccecntric exercises in paretic lower limb. FM is a massage technique that incorporates non-end-range joint motion (passive, active assisted or active) with massage (tissue compression) to treat musculotendinous dysfunction. During FM application, the target muscle and its surrounding soft tissues are compressed and the associated joint is moved to cause muscle lengthening or shortening. Shortening, or approximation, is used to aid the tissue in dispersing metabolic waste and improve the healing matrix of the injured tissue. Lengthening is used during the remodeling phase of tissue healing to improve mechanical strength, flexibility, and rigidity of the tissue. A combination of the two types can be used to aid in restoring the normal gliding of the connective tissue fibers during function. Eccentric resistance training is a method to improve strength and function that emphasizes the eccentric phase of the muscular contraction.

Other: Group A Funtional massage therapy and eccentric exercise in lower limb

Group B Eccentric exercise in paretic lower limb

ACTIVE COMPARATOR

Eccecntric exercises in paretic lower limb. Eccentric resistance training is a method to improve strength and function that emphasizes the eccentric phase of the muscular contraction. Some studies concluded that it allows the subject to produce more power than traditional training and to do it with a lower metabolic cost.5 It has also been reported that this type of training favors neural conduction and contributes to the prevention and improvement of health

Other: Group B. Eccentric exercises training

Interventions

Group A Funtional massage therapy and eccentric exercise in lower limb OTHER

Functional Massage (FM) on lower limb. FM is a therapeutic technique that incorporates joint motion with massage to treat musculotendinous pain and impairments. Eccentric exercises training for lower limb. It can be useful in strengthening the muscles of the lower limbs, and promoting gait performance.

Group A Functional massage in addition to eccentric exercise in paretic lower limb

Group B. Eccentric exercises training OTHER

Eccentric exercises training and therapeutic exercise is a type of physical activity used to treat or prevent injuries and improve functional outcomes. Eccentric exercises focuses on movements, or phases of a movement, that lengthen the muscles. Some examples of eccentric exercise include lowering into a squat or lowering into a press-up. In contrast, when a person pushes out of a squat or press-up, this shortens the muscles. This is known as concentric movement

Group B Eccentric exercise in paretic lower limb

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes ≥ 18 years of age.
• Adults who have been diagnosed with an ischemic or hemorrhagic stroke, according to the diagnostic criteria established by the WHO; corresponding to ICD-11 in January 2022, as confirmed by CT or MRI
• Stroke ≥ 6 months
• Hospital discharge
• Stable condition
• Ability to understand and follow simple instructions
• Ability to read, write and speak Spanish or Catalan with acceptable visual and auditory acuity
• Living in the Barcelona metropolitan area
• Able to comply with scheduled visits, treatment plan, and other trial procedures
• Increased muscle tone in Lower Extremities (EEII) according to the modified Ashworth Scale (MAS) grade ≥ 1+ \<4 11) Voluntary activation capacity and muscle strength in Lower Extremities (EEII) according to Daniels Scale grade ≥ 3 12) Ability to walk 10 meters, without assistance from third parties. 13) Minimum grade of 7 in depression, 5 in anxiety and 10 in stress according to the Depression, Anxiety and Stress Scale (DASS-21).

You may not qualify if:

• Nervous system disease and/or cardiac, pulmonary dysfunction/failure.
• History of mental disorders and/or cognitive impairment that make it difficult or impossible to follow instructions ≤ 21 Folstein's Mini Mental Test (MMSE)
• Hearing impairment
• History of psychotropic drug use in the last 6 months
• Consumption of drugs to reduce spasticity or having undergone botulinum toxin treatment in the last 3 months.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat Del Vallés, Barcelona, 08195, Spain

Location

Related Publications (10)

• Garcia-Rueda L, Cabanas-Valdes R, Salgueiro C, Perez-Bellmunt A, Rodriguez-Sanz J, Lopez-de-Celis C. Immediate effects of TECAR therapy on lower limb to decrease hypertonia in chronic stroke survivors: a randomized controlled trial. Disabil Rehabil. 2025 Mar;47(5):1214-1223. doi: 10.1080/09638288.2024.2365992. Epub 2024 Jul 3.

  PMID: 38958103 BACKGROUND

• Garcia-Rueda L, Cabanas-Valdes R, Salgueiro C, Rodriguez-Sanz J, Perez-Bellmunt A, Lopez-de-Celis C. Immediate Effects of TECAR Therapy on Gastrocnemius and Quadriceps Muscles with Spastic Hypertonia in Chronic Stroke Survivors: A Randomized Controlled Trial. Biomedicines. 2023 Nov 4;11(11):2973. doi: 10.3390/biomedicines11112973.

  PMID: 38001972 BACKGROUND

• Fan J, Li X, Yu X, Liu Z, Jiang Y, Fang Y, Zong M, Suo C, Man Q, Xiong L. Global Burden, Risk Factor Analysis, and Prediction Study of Ischemic Stroke, 1990-2030. Neurology. 2023 Jul 11;101(2):e137-e150. doi: 10.1212/WNL.0000000000207387. Epub 2023 May 17.

  PMID: 37197995 BACKGROUND

• GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

  PMID: 34487721 BACKGROUND

• Cabanas-Valdes R, Calvo-Sanz J, Serra-Llobet P, Alcoba-Kait J, Gonzalez-Rueda V, Rodriguez-Rubio PR. The Effectiveness of Massage Therapy for Improving Sequelae in Post-Stroke Survivors. A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Apr 21;18(9):4424. doi: 10.3390/ijerph18094424.

  PMID: 33919371 BACKGROUND

• Cabanas-Valdes R, Garcia-Rueda L, Salgueiro C, Perez-Bellmunt A, Rodriguez-Sanz J, Lopez-de-Celis C. Assessment of the 4-meter walk test test-retest reliability and concurrent validity and its correlation with the five sit-to-stand test in chronic ambulatory stroke survivors. Gait Posture. 2023 Mar;101:8-13. doi: 10.1016/j.gaitpost.2023.01.014. Epub 2023 Jan 20.

  PMID: 36696822 BACKGROUND

• Plasencia RR, VAN Zant J, Charron SC, Manderachia NM, Dickson J, Malek MH. Massage prior to exercise delays the onset of the physical working capacity at the fatigue threshold (PWCFT). J Sports Med Phys Fitness. 2025 May;65(5):650-656. doi: 10.23736/S0022-4707.24.16288-3. Epub 2024 Nov 11.

  PMID: 39526873 BACKGROUND

• Clos P, Lepers R, Garnier YM. Locomotor activities as a way of inducing neuroplasticity: insights from conventional approaches and perspectives on eccentric exercises. Eur J Appl Physiol. 2021 Mar;121(3):697-706. doi: 10.1007/s00421-020-04575-3. Epub 2021 Jan 2.

  PMID: 33389143 BACKGROUND

• Kinoshita Y, Osawa G, Morita T, Kawauchi M, Minowa T. [Diabetic glomerular sclerosis]. Nihon Rinsho. 1969 Aug;27(8):2045-53. No abstract available. Japanese.

  PMID: 5390411 BACKGROUND

• Kwakkel G, Stinear C, Essers B, Munoz-Novoa M, Branscheidt M, Cabanas-Valdes R, Lakicevic S, Lampropoulou S, Luft AR, Marque P, Moore SA, Solomon JM, Swinnen E, Turolla A, Alt Murphy M, Verheyden G. Motor rehabilitation after stroke: European Stroke Organisation (ESO) consensus-based definition and guiding framework. Eur Stroke J. 2023 Dec;8(4):880-894. doi: 10.1177/23969873231191304. Epub 2023 Aug 7.

  PMID: 37548025 BACKGROUND

Related Links

• Functional massage therapy focuses on enhancing the function of muscles, joints, and connective tissues to improve movement and reduce pain. Unlike general massage techniques aimed at relaxation, this method is goal-oriented and highly targeted.
• Eccentric exercise focuses on movements that lengthenTrusted Source the muscles. For example, when someone lowers into a squat, their leg muscles lengthen. Eccentric movements require less oxygen and energy than other types of movement.
• The Hospital morbidity survey provides information on hospital discharges with hospitalisation based on the main diagnosis associated with the discharge. The main objective is to know the demographic and health characteristics of patients in Spain.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pere Ramón Rodríguez Rubio Pere Ramón Rodríguez-Rubio, PhD

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

• Pere Ramón Rodríguez-Rubio Rodríguez-Rubio, PhD

  Universitat Internacional de Catalunya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rosa Cabanas Valdés

Model Details: A type of clinical trial in which all participants receive the same two treatments, but the order in which they receive them depends on the group to which they are randomly assigned. All participants will receive all the interventions but the order in which they will receive the interventions (the sequence) is randomised One group will get Group A during the first period of the trial, then Group B during the second period. A week of rest will be between groups. The other group will get Group B during the first period of the trial, then Group A during the second period.

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: April 5, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)