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

NCT06898242 | Active Not Recruiting

• 1 other identifier: 6661
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injury; Brain Injury, Vascular; Brain Injuries, Traumatic

Keywords

acquired brain injury; traumatic; spasticity; myofascial manual treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tolerance and safety of treatment

  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

  Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)

Other Outcomes (5)

• Changes in muscle echostructure

  Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)

• Changes in muscle echostructure

  Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)

• Changes in muscle echostructure

  Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)

Study Arms (2)

Group A: rehabilitative treatment following rehabilitation project plus manual myofascial treatment

EXPERIMENTAL

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; Other: Rehabilitative treatment following rehabilitation project

Group B: rehabilitative treatment following rehabilitation project

ACTIVE COMPARATOR

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

Interventions

Manual myofascial treatment direct to upper and lower limb OTHER

Manual treatment direct specifically on fascia connective tissue

Group A: rehabilitative treatment following rehabilitation project plus manual myofascial treatment

Rehabilitative treatment following rehabilitation project OTHER

Intensive multidisciplinary rehabilitation program for at least 180 minutes/day, 6 days a week, following rehabilitation project

Group A: rehabilitative treatment following rehabilitation project plus manual myofascial treatment; Group B: rehabilitative treatment following rehabilitation project

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

UOC Neuroriabilitazione ad Alta Intensità COD. 75 Policlinico Gemelli

Roma, RM, 00168, Italy

Location

Related Publications (8)

• 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.

  PMID: 29912727 BACKGROUND

• 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.

  PMID: 31952141 BACKGROUND

• 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.

  PMID: 7131136 BACKGROUND

• 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.

  PMID: 17638613 BACKGROUND

• 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.

  PMID: 21589701 BACKGROUND

• 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.

  PMID: 25530960 BACKGROUND

• 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.

  PMID: 19800625 BACKGROUND

• 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.

  PMID: 31579488 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Cerebrovascular Trauma; Brain Injuries, Traumatic; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luca Padua, MD, phD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 27, 2025
• Study Start: March 13, 2025
• Primary Completion: September 24, 2025
• Study Completion: March 24, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)