跳至主要内容
临床试验/NCT04824768
NCT04824768已完成不适用

Immediate Effects of Tecar Therapy on Spasticity and Functionality of the Lower Limb in Chronic Post-stroke Survivors.

Universitat Internacional de Catalunya4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
4
主要终点
Muscle tone

研究概览

简要总结

Spasticity is due to an abnormal processing of a normal input from muscle spindles in the spinal cord.

详细描述

Stroke often affects sensory-motor networks and descending tracts, as reflected by several signs of upper motor neuron syndrome. One symptom is post-stroke spasticity. It is due to an abnormal processing of a normal input from muscle spindles in the spinal cord. It is often defined by a velocity-dependent increase in muscle tone and a resistance to passive muscle stretch. It has neural (increased reflex activity) and non-neural (altered visco-elastic properties due to immobilization) components. The prevalence of spasticity ranges from 25%-43% at 6 months post-stroke. Chronic spasticity can decrease the number of sarcomeres. As a result, the proportion of connective tissue in the muscle and fasciae can increase. These subjects present fibrosis that have augmented passive muscle stiffness due to structural and functional adaptations inside the muscle cells. Soft tissue changes may cause the pulling forces to be transmitted more readily to the muscle spindles, which can intensify sensory input thus increasing spasticity. It has a potential impact on lower limb function, which affects passive muscle stretch, range of motion, and motor unit recruitment during voluntary contraction. In the stance phase of gait, the deformity also produces an inadequate base of support, which is associated with balance impairments. This increases the risk of falls, reduces patient participation in daily activities, and decreases health-related quality of life. Physiotherapy treatments of spasticity aim to decrease excessive muscular tone, ease mobility, give the patient the sense of right position and avoid joint limitations.

Functional massage is a non-invasive manual therapy technique that combines rhythmical passive joint mobilization with compression and decompression of the muscular belly with the tendinomuscular insertions to treat. It is indicated in cases of muscle stiffness associated with pain.

Tecar therapy or Capacitive Resistive Electric Transfer Therapy (CRet) is a non-invasive diathermy technique which provides high frequency energy (300 KHz-1.2 MHz) generating a thermal effect on soft tissues. CRet is used to facilitate tissue regeneration, and it does not need a surface-cooling system, as its wave frequency is lower than in conservative diathermy. CRet effectiveness has been evaluated in several studies. It is effective in the treatment of chronic musculoskeletal disorders, where a temperature increase on deep tissues is needed in order to generate changes on its viscoelasticity. This effect may be beneficial in the spasticity treatment since spasticity onset and development may be affected by structural changes in muscular and tendinous fibers.

No studies on the effects of CRet in post-stroke spasticity treatment were found.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

An introductory massage was performed on the lumbar region and hamstrings of the most affected leg, in conjunction with Tecar therapy in the resistive modality (0W). Functional Massage was then performed on the gastrocnemius, with Tecar in resistive mode (0W), and then in capacitive mode (0VA).

入排标准

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

入选标准

  • Diagnosis of Stroke
  • Scoring 1 on the Modified Ashworth Scale (MAS) for hip or/and knee flexion or/and ankle dorsiflexion on the most affected limb
  • Scoring 25 or plus on the Montreal Cognitive Assessment (MoCA)

排除标准

  • Having suffered a traumatism on the lower limbs three months, or less, before the intervention
  • Suffer other neurological disease
  • Presence of osteosynthetic material
  • Pacemaker wearing
  • Treatment with botulinum toxin or another antispastic medication, six months , or less, before the intervention
  • Carry baclofen pump
  • Functional inability to adopt the prone or supine position on the treatment table
  • Functional inability to sit, stand and walk
  • Poor language and communication skills that make difficult to understand the informed consent
  • Contraindications to Functional Massage (infectious diseases, inflammatory vascular conditions, acute inflammation, hemorrhagic, fever)

结局指标

主要结局

Muscle tone

时间窗: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment

To evaluate the immediate changes in terms of muscle tone on the rectus femoris, medialis and gastrocnemius after one session with CRet as coadjuvant of functional massage by modified Ashworth Scale of Hip flexion-extension, knee flexion-extension, ankle plantar flexion and dorsiflexion. The minimum and maximum values are 0 and 4, higher scores mean a worse outcome.

次要结局

  • Muscle stiffness(T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment)
  • Passive range of motion(T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment)
  • Muscle relaxation(T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment)
  • Muscle flexibility(T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment)

研究者

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

Rosa Cabanas Valdés

PhD

Universitat Internacional de Catalunya

研究点 (4)

Loading locations...

相似试验