Brain InjuryMyosABINCT06898242
Early Myofascial Manual Treatment in Subjects With Spasticity Following Acquired Brain Injury
A study testing Manual myofascial treatment direct to upper and lower limb and Rehabilitative treatment following rehabilitation project in people with Brain Injury and Brain Injury, Vascular, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Brain Injury, Vascular, Brain Injuries, Traumatic
- What is being tested?
- Manual myofascial treatment direct to upper and lower limb and Rehabilitative treatment following rehabilitation project
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2025to 24 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC Neuroriabilitazione ad Alta Intensità COD. 75 Policlinico Gemelli
Roma, RM, 00168
About this study
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.
Read more
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.
- Being tested
- Manual myofascial treatment direct to upper and lower limb, Rehabilitative treatment following rehabilitation project
- Keywords
- acquired brain injury, traumatic, spasticity, myofascial manual treatment
- Medical subject headings
- Brain Injuries, Cerebrovascular Trauma, Brain Injuries, Traumatic, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual myofascial treatment direct to upper and lower limbOther
Manual treatment direct specifically on fascia connective tissue
Rehabilitative treatment following rehabilitation projectOther
Intensive multidisciplinary rehabilitation program for at least 180 minutes/day, 6 days a week, following rehabilitation project
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Rehabilitative treatment following rehabilitation project |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)
Secondary outcomes (2)
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)
Measured: 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
Measured: Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start13 Mar 2025
- Primary completion24 Sep 2025 (estimated)
- Study completion24 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PADUA LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luca Padua, MD, phD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898242
- Sponsor's protocol ID
- 6661
- Acronym
- MyosABI
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29912727Posada-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.
PubMed 31952141Heckmatt 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.
PubMed 7131136Dietz 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.
PubMed 17638613Stecco 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.
PubMed 21589701Trompetto 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.
PubMed 25530960Hinz 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.
PubMed 19800625Stecco 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.
PubMed 31579488
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Myofascial Manual Treatment in Subjects With Spasticity Following Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06898242
- Acronym / sponsor ID
- MyosABI / 6661
- Keywords
- acquired brain injury, traumatic, spasticity, myofascial manual treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 24 Sep 2025 (estimated)
- Study completion
- 24 Mar 2026 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: rehabilitative treatment following rehabilitation project plus manual myofascial treatment | Experimental | Other: Manual myofascial treatment direct to upper and lower limb, Other: Rehabilitative treatment following rehabilitation projectPartecipant 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. |
| Group B: rehabilitative treatment following rehabilitation project | Active comparator | Other: Rehabilitative treatment following rehabilitation projectPartecipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Spasticity at MAS scale > 2
- Non consolidatetd fracture and/or muscle injuries to the limbs
- Deep vein thrombosis
- Neoplasms
- Hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual myofascial treatment direct to upper and lower limbManual treatment direct specifically on fascia connective tissue | Other | Group A: rehabilitative treatment following rehabilitation project plus manual myofascial treatment |
| Rehabilitative treatment following rehabilitation projectIntensive multidisciplinary rehabilitation program for at least 180 minutes/day, 6 days a week, following rehabilitation project | Other | Group A: rehabilitative treatment following rehabilitation project plus manual myofascial treatment, Group B: rehabilitative treatment following rehabilitation project |
Primary outcome
Modification of spasticity through Modified Ashworth Scale
Time frame: Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)
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)
2 secondary outcomes
Tolerance and safety of treatment
Time frame: 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
Time frame: Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 29912727Ozcakar 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.
- Background: PubMed 31952141Posada-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.
- Background: PubMed 7131136Heckmatt 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.
- Background: PubMed 17638613Dietz 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.
- Background: PubMed 21589701Stecco 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.
- Background: PubMed 25530960Trompetto 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.
- Background: PubMed 19800625Hinz 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.
- Background: PubMed 31579488Stecco 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Padua, MD, phD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual myofascial treatment direct to upper and lower limb and Rehabilitative treatment following rehabilitation project in people with Brain Injury and Brain Injury, Vascular, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification of spasticity through Modified Ashworth Scale (time frame: Changes from baseline (T0), 4 weeks of treatment (T1), 4 weeks of follow up (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06898242, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.