Early Myofascial Manual Treatment in Subjects With Spasticity Following Acquired Brain Injury (MyosABI)

Spasticity is characterized by an increase in muscle tone that is velocity-dependent and caused by the exaggeration of the stretch reflex. Clinically, it is found in 70-85% of patients with spinal cord injury at one year, 40-45% in patients with stroke at 12 months, and 25% in patients with traumatic brain injury at one year.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Brain Injury; Brain Injuries, Traumatic; Brain Injury, Vascular
• Intervention / Treatment: Other: Manual myofascial treatment direct to upper and lower limb; Other: Rehabilitative treatment following rehabilitation project

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00168
      • UOC Neuroriabilitazione ad Alta Intensità COD. 75 Policlinico Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aquired brain injuries from 40 days to 6 months after the event
• 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:

• Spasticity at MAS scale > 2
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Manual myofascial treatment direct to upper and lower limb; Manual treatment direct specifically on fascia connective tissue; Other: Rehabilitative treatment following rehabilitation project; Intensive multidisciplinary rehabilitation program for at least 180 minutes/day, 6 days a week, following rehabilitation project
Active Comparator: 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.	Other: Rehabilitative treatment following rehabilitation project; Intensive multidisciplinary rehabilitation program for at least 180 minutes/day, 6 days a week, following rehabilitation project

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modification of spasticity through Modified Ashworth Scale	Evaluation of changes in the degree of spasticity of upper and lower limbs through Modified Ashworth Scale (lower degree 0: no increase in muscle tone; maximum degree 4: affected part rigid in flexion or extension)	Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance and safety of treatment	Evaluation of safety and tolerability of treatment throught Pain Assessment in Advanced Dementia scale (minimum degree 0: no pain; maximum degree 10: maximum pain)	Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)
Evaluation of changes in the degree of functional use of the upper and lower limbs through Motricity Index Scale	Motricity Index Scale: minimum degree 0: no movement; maximum degree: movement performed with normal force	Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in muscle echostructure	Evaluation of muscle echostructure through assessment of anterior-posterior diameter (unit of measure: mm) at medial gemellus muscle and biceps brachii muscle.	Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)
Changes in muscle echostructure	Evaluation of muscle echostructure through assessment of Heckmatt Index at medial gemellus muscle and biceps brachii muscle (unit of measure: prime numbers from 1 to 4; 1: normal aspect of muscle echostructure, clear bone echo; 4: high echointensity of muscle, absent bone echo)	Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)
Changes in muscle echostructure	Evaluation of muscle echostructure through assessment of pennation angle at medial gemellus muscle and biceps brachii muscle (unit of measure: degrees)	Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)
Evaluation of electrodermal activity	Evaluation of modification of skin conductance through assessment of modification of electrodermal activity (unit of measure: prime numbers)	Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow-up (T2)
Changes in muscle echostructure	Evaluation in muscle echostructure through assessment of cross sectional area (Unit of Measure: cm^2) at medial gemellus muscle and biceps brachii muscle.	Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Luca Padua, MD, phD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

General Publications

• 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 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): September 24, 2025
• Study Completion (Estimated): March 24, 2026

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: spasticity; acquired brain injury; traumatic; myofascial manual treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Muscle Spasticity; Wounds and Injuries; Brain Injuries; Vascular System Injuries; Cerebrovascular Trauma
• Other Study ID Numbers: 6661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No