NCT06922149Completed
Functional Massage and Eccentric Exercise in Stroke Survivors (FM-EE Stroke)
Effects of Functional Massage Combined With Eccentric Exercise on Muscle Tone and Motor Function of the Lower Limb in Patients With Chronic Stroke: A Pilot Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 3 Apr 2025
- Start date
- 5 Apr 2025
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Universitat Internacional de Catalunya
- Diseases
- Stroke
- NCT number
- NCT06922149
What you commit to
- Study type: Interventional
- Participants enrolled: 8
- From 5 Apr 2025 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Consumption of drugs to reduce spasticity or having undergone botulinum toxin treatment in the last 3 months.
Other illness
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitat Internacional de Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.