Early Myofascial Manual Treatment in Subjects With Spasticity Following Acquired Brain Injury
NCT ID: NCT06898242
Last Updated: 2025-04-02
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
24 participants
INTERVENTIONAL
2025-03-13
2026-03-24
Brief Summary
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The term 'Severe Acquired Brain Injury' refers to a condition characterized by brain damage that causes a coma with an acute phase score of 8 on the Glasgow Coma Scale (GCS), lasting more than 24 hours. It may be caused by vascular, traumatic, anoxic, infectious, toxic-metabolic, or neoplastic damage, which can cause multiple and complex sensory, cognitive, and behavioral impairments that lead to significant disability. Spasticity occurs frequently in patients with GCA, often at an early stage, with serious repercussions on the rehabilitation process and outcome.
Numerous studies indicate that spasticity due to neurological damage is supported, in addition to hyperexcitable stretch reflexes, by changes in the connective tissues of the peripheral limbs that increase muscle resistance to passive movement. After neurological damage, and starting 1 week after immobilization, alterations in the muscles and connective tissue can be observed: changes in the muscle fibers, changes in the collagen tissue, and changes in the properties of the tendons. It is believed that the quantitative and qualitative changes in the intramuscular connective tissue contribute to the deterioration of the properties and functions of the immobilized muscle, which contributes to the establishment and progression of spasticity.
In patients with spastic paresis, therapeutic interventions are intended to prevent prolonged shortening of the muscles and mobilize the affected areas. According to recent research, the connective tissue is particularly sensitive to mechanical stress, particularly deep manual manipulation and vibration. Several studies have suggested that myofascial release therapy can be a complementary treatment in patients with neurological disorders to reduce muscle spasticity and increase joint mobility.
Myofascial release techniques can be hypothesized to be a valid integrated treatment for spasticity in patients with sequelae from GCA, but their use in this area has been little studied and no studies have been conducted in the post-acute period of intensive hospitalization.
The purpose of the present study is to determine whether manual myofascial release techniques, applied to the upper and lower limbs, are safe, tolerable, and effective in modifying the degree of spasticity and improving functional activity in patients with GCA. Additionally, changes in muscle structure will be evaluated by ultrasound: cross-sectional area, anteroposterior diameter, and pennation angle.
Finally, we will measure the effects of manual myofascial treatment stimulation by measuring electrodermal activity (EDA), which is a non-invasive method in which an electrode bracelet is applied to the patient's right wrist to measure the electrical conductance of the skin, which is a function of the autonomic nervous system, which is controlled by the sweat glands. Various sensory stimulations, including visual, auditory, olfactory, tactile, vestibular, and proprioceptive stimulations, can produce a physical sensation that can influence the patient's sensorimotor output, resulting in physiological changes in the activity of the ANS as a consequence of the processing of sensory afferents. A response to an appropriate sensory stimulus can be regarded as a manifestation of a change in consciousness.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A: rehabilitative treatment following rehabilitation project plus manual myofascial treatment
Partecipant in group A will perform normal rehabilitative treatment as foreseen by the rehabilitation project plus manual myofascial treatment on the upper and lower limbs with a frequency of 2 times a week for a maximum of 30 minutes for 4 weeks. In particular, on the upper limbs, manual myofascial treatment will be applied in all sessions to the intraosseous membrane and if necessary to the palmar fascia, and brachial fascia sites. On the lower limbs, it will be applied in all sessions to the intraosseous membrane and if necessary to the plantar fascia, and crural fascia sites.
Manual myofascial treatment direct to upper and lower limb
Manual treatment direct specifically on fascia connective tissue
Rehabilitative treatment following rehabilitation project
Intensive multidisciplinary rehabilitation program for at least 180 minutes/day, 6 days a week, following rehabilitation project
Group B: rehabilitative treatment following rehabilitation project
Partecipant in group B will carry out the normal rehabilitation program, as foreseen by the rehabilitation project, for a total treatment time equal to that of the treated group.
Rehabilitative treatment following rehabilitation project
Intensive multidisciplinary rehabilitation program for at least 180 minutes/day, 6 days a week, following rehabilitation project
Interventions
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Manual myofascial treatment direct to upper and lower limb
Manual treatment direct specifically on fascia connective tissue
Rehabilitative treatment following rehabilitation project
Intensive multidisciplinary rehabilitation program for at least 180 minutes/day, 6 days a week, following rehabilitation project
Eligibility Criteria
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Inclusion Criteria
* Spasticity at upper orvlower limbs quantified at MAS scale \>= than 1
* Age \>= 18 years
* Patient/Caregiver ability to understand and sign the informed consent
Exclusion Criteria
* Non consolidatetd fracture and/or muscle injuries to the limbs
* Deep vein thrombosis
* Neoplasms
* Hemodynamic instability
* Local infections to the limbs
* Recent treatment with botulinum toxin (within 40 days)
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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PADUA LUCA
associated professor
Principal Investigators
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Luca Padua, MD, phD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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UOC Neuroriabilitazione ad Alta Intensità COD. 75 Policlinico Gemelli
Roma, RM, Italy
Countries
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References
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Ozcakar L, Ata AM, Kaymak B, Kara M, Kumbhare D. Ultrasound imaging for sarcopenia, spasticity and painful muscle syndromes. Curr Opin Support Palliat Care. 2018 Sep;12(3):373-381. doi: 10.1097/SPC.0000000000000354.
Posada-Quintero HF, Chon KH. Innovations in Electrodermal Activity Data Collection and Signal Processing: A Systematic Review. Sensors (Basel). 2020 Jan 15;20(2):479. doi: 10.3390/s20020479.
Heckmatt JZ, Leeman S, Dubowitz V. Ultrasound imaging in the diagnosis of muscle disease. J Pediatr. 1982 Nov;101(5):656-60. doi: 10.1016/s0022-3476(82)80286-2.
Dietz V, Sinkjaer T. Spastic movement disorder: impaired reflex function and altered muscle mechanics. Lancet Neurol. 2007 Aug;6(8):725-33. doi: 10.1016/S1474-4422(07)70193-X.
Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.
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.
Hinz B. The myofibroblast: paradigm for a mechanically active cell. J Biomech. 2010 Jan 5;43(1):146-55. doi: 10.1016/j.jbiomech.2009.09.020. Epub 2009 Oct 3.
Stecco A, Pirri C, Caro R, Raghavan P. Stiffness and echogenicity: Development of a stiffness-echogenicity matrix for clinical problem solving. Eur J Transl Myol. 2019 Sep 12;29(3):8476. doi: 10.4081/ejtm.2019.8476. eCollection 2019 Aug 2.
Other Identifiers
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6661
Identifier Type: -
Identifier Source: org_study_id
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