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临床试验/NCT04851756
NCT04851756已完成不适用

Immediate Effect of Capacitive Resistive Electric Transfer Therapy (CRet) Associated With Functional Massage on the Rectus Femoris and Gastrocnemius in Post-stroke Spasticity

Universitat Internacional de Catalunya2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年4月29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
2
主要终点
Gait Performance

研究概览

简要总结

The purpose of this study is to assess the immediate effects of CRet associated to Functional Massage (F.M) in terms of gait and functionality after stroke

详细描述

Spasticity is a sensory motor disturbance as a result of a damage in the upper motoneuron, showing as an involuntary, intermittent and sustained activation of muscles. It is the most common feature after stroke, which most affects motor and functional recovery.

Spasticity prevalence runs from 25% to 46% after the first six months post-stroke, and it is estimated that 16% will require treatment.

Spasticity has neural (increased reflex activity) and biomechanical (altered viscoelastic properties due to immobilization) components. The initial paralysis after stroke modifies the bio mechanical properties of the muscle, thus shortening its fibers and causing an increase of velocity-dependent reflexes in the affected area. Spasticity manifests with paresis, increased muscle tone, muscular hyperactivity, decreased range of movement and pain.

Gait disorder is one of the main physical limitations in stroke survivors and an important target for stroke rehabilitation, since 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 (F.M) is a non-invasive manual therapy technique that combines rhythmical passive mobilizations of the joints with gentle massage and compression of the muscles to be treated. As massage therapy is effective to improve spastic muscles and gross motor functions, F.M may be appropriate in treating post stroke spasticity and gait function. No studies were found on its effectiveness in patients with post-stroke spasticity.

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)

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 flexion and/or knee flexion or/and ancke dorsiflexion on the most affected limb
  • Scoring 25 or plus on the Montreal Cognitive Assessment (MoCA)
  • Signing the informed consent form

排除标准

  • Having suffered a traumatism on the lower limbs three months, or less, before the intervention
  • Other neurological diseases
  • 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 form
  • Contraindications to Functional Massage (infectious diseases, inflammatory vascular conditions, acute inflammation, haemorrhagia, fever)

结局指标

主要结局

Gait Performance

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

To evaluate change in gait speed after one session with CRet associated to F.M by the 4-metre-walk-test (4MWT). The assessor will indicate the participant to walk 4m at her fastest velocity. The timing will ve recorded.

Functional Lower Extremity Force

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

To evaluate change in functional lower extremity force after one session with CRet associated to F.M by the 5 times sit-to-stand test. Participants will be in the seating position on the treatment bed, and will stand and sit for five times. Time will start when the tester says 'go'.Time will stop when the participant's body touches the chair following the fifth repetition.

次要结局

  • Active Range of Movement (AROM) of the anckle(T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ])
  • AROM of the knee(T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment ])
  • Global Improvement(Baseline up 30 min after treatment)

研究者

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

Laura García Rueda

Principal Investigator

Universitat Internacional de Catalunya

研究点 (2)

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