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临床试验/NCT06898242
NCT06898242进行中(未招募)不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
1
主要终点
Modification of spasticity through Modified Ashworth Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: Manual myofascial treatment direct to upper and lower limb (Other)

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.

干预措施: Rehabilitative treatment following rehabilitation project (Other)

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.

干预措施: Rehabilitative treatment following rehabilitation project (Other)

结局指标

主要结局

Modification of spasticity through Modified Ashworth Scale

时间窗: 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)

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

PADUA LUCA

associated professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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