ClinConnect ClinConnect Logo
Search / Trial NCT06922149

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

Launched by UNIVERSITAT INTERNACIONAL DE CATALUNYA · Apr 3, 2025

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Stroke, Eccentric Exercises, Functional Massage, Muscle Tone

ClinConnect Summary

The FM-EE Stroke trial is studying the combined effects of functional massage therapy and eccentric exercise on stroke survivors who have been living with the effects of a stroke for at least six months. The goal is to see if this combination can help reduce muscle stiffness (spasticity) and improve movement, flexibility, and overall quality of life. Participants will engage in eight sessions of treatment at a university facility, where they will receive both types of therapy to help enhance their lower limb function and possibly reduce feelings of stress, anxiety, and depression.

To participate in this study, individuals must be at least 18 years old, have experienced a stroke confirmed by medical imaging, and be in a stable condition. They should also be able to walk 10 meters independently and live in the Barcelona metropolitan area. The trial is designed to be safe, with minimal risks, and participants can use supportive devices like canes or braces during the exercises. This trial offers an exciting opportunity to explore new ways to help stroke survivors regain their strength and improve their daily lives.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Both sexes ≥ 18 years of age.
  • 2. 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
  • 3. Stroke ≥ 6 months
  • 4. Hospital discharge
  • 5. Stable condition
  • 6. Ability to understand and follow simple instructions
  • 7. Ability to read, write and speak Spanish or Catalan with acceptable visual and auditory acuity
  • 8. Living in the Barcelona metropolitan area
  • 9. Able to comply with scheduled visits, treatment plan, and other trial procedures
  • 10. 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).
  • Exclusion Criteria:
  • 1. Nervous system disease and/or cardiac, pulmonary dysfunction/failure.
  • 2. History of mental disorders and/or cognitive impairment that make it difficult or impossible to follow instructions ≤ 21 Folstein's Mini Mental Test (MMSE)
  • 3. Hearing impairment
  • 4. History of psychotropic drug use in the last 6 months
  • 5. Consumption of drugs to reduce spasticity or having undergone botulinum toxin treatment in the last 3 months.

About Universitat Internacional De Catalunya

The Universitat Internacional de Catalunya (UIC) is a prestigious higher education institution situated in Barcelona, Spain, renowned for its commitment to academic excellence and innovation in research. With a strong emphasis on interdisciplinary collaboration, UIC actively engages in clinical trials that aim to advance medical knowledge and improve patient outcomes. The university's dedicated research teams are equipped with cutting-edge facilities and experienced professionals, enabling them to conduct rigorous studies across various health-related fields. UIC's focus on ethical practices and compliance ensures that all clinical trials are conducted with the highest standards of scientific integrity and participant safety.

Locations

Sant Cugat Del Vallés, Barcelona, Spain

Patients applied

0 patients applied

Trial Officials

Pere Ramón Rodríguez Rubio Pere Ramón Rodríguez-Rubio, PhD

Study Director

Universitat Internacional de Catalunya

Pere Ramón Rodríguez-Rubio Rodríguez-Rubio, PhD

Study Chair

Universitat Internacional de Catalunya

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported