Repeated Muscle Vibration in Acute Stroke

赞助:

合作者:

信息的提供 (责任方):

Vittorio Di Piero，University of Roma La Sapienza

追踪信息

首次提交日期 ^ICMJE

September 29, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

January 1, 2016

预计主要完成日期

July 1, 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Motor Recovery[ Time Frame: 4 ± 1 days ]

Motor recovery is expressed as the differences over time (from T-0 to T-1) between the two groups concerning Motricity Index scale scores. The Motricity Index is an ordinal scale that evaluates motor skills and functional limbs in patients with neurological diseases. The movements object of the evaluation are in total 6 (3 for each limb) The scores range from 0 (i.e. no movement) to 33 (ie normal movements) for a maximum of 100 for each limb.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Motor Recovery within/associated to synergies[ Time Frame: 4 ± 1 days ]
Motor recovery occurring within/associated to synergies is expressed as the differences over time (from T-0 to T-1) between the two groups concerning Fugl-Meyer scale scores. This scale consists of 10 subtests (6 subtests for the upper limb and 4 for the lower limbs), which evaluate the movements occurring within the synergies (flexor or extensor) and the movements that occur with the association of synergies. It consists of 50 items and provides a maximum score of 100 points, which corresponds to normal traction (66 points for the upper limb, 34 for the lower one) and a minimum score of 0 (no traction)
Stroke Recovery[ Time Frame: 4 ± 1 days ]
Stroke recovery is expressed as the differences over time (from T-0 to T-1) between the two groups concerning NIH Stroke Scale scores. This scale assesses the stroke severity; it consists of 11 items and the total score goes from a minimum of 0 = normal neurological examination at a maximum of 42, severe severe neurological deficit.
Spasticity Recovery[ Time Frame: 4 ± 1 days ]
Post-stroke Spasticity is assessed with Ashworth scale, modified by Bohannon and Smith. The total score goes from 0 (no spasticity) to 4 (maximum spasticity grade)

描述性信息

简略标题 ^ICMJE

Repeated Muscle Vibration in Acute Stroke

正式标题 ^ICMJE

Effects of Repeated (Focal) Muscle Vibration (rMV) on Motor Recovery After Acute Stroke: a Randomized Sham-controlled Study

简要概况

prospective randomized double-blind sham-controlled study aimed to investigate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients, treated within 72 hours from symptoms onset

详细说明

This is a prospective randomized double-blind sham-controlled study. After enrollment (T-0), patients are randomly placed into the vibration group (VG) or the control group (CG), by using a computer-generated randomization list. VG patients receive rMV treatment while those of CG receive the sham one. Both treatments are carried out during the 1st, 2nd and 3rd day after enrollment. Physiokinesitherapy (PT) is carried out in all patients every day, starting soon after T-0 clinical evaluation. Patients are re-evaluated after 4 ± 1 days (T-1), at the end of treatment. Upon admission, all participants' demographic details and medical history are recorded. All patients undergo a clinical examination, performed at all time-points by an experienced investigator, blinded to group assignment and different from the recruiting one. Clinical evaluation consists of stroke severity evaluation, by means of NIH Stroke Scale; motor and functional limbs abilities are evaluated by using both the Fugl-Meyer scale and the Motricity Index; post-stroke spasticity is assessed with Ashworth scale, modified by Bohannon and Smith. All participants undergo a daily rehabilitation program. The physical therapist is instructed about duration, frequency, and content of therapy in order to ensure uniformity in treatment procedures, and blinded to patients' treatment allocation. Low-amplitude rMV (frequency 100 Hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (Cro®System, NEMOCOsrl). The rMV treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (for each treated limb), interspersed with a 5-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle. Otherwise, the CG participants undergo the sham rMV by positioning the vibrator close to the tendon but without touching the skin. In this condition, patients are only subject to the faint buzzing sound of the vibrator

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: prospective randomized double-blind sham-controlled study
盲法: Interventional
盲法描述:double-blind
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Device: Vibration
Low-amplitude rMV (frequency 100 Hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (Cro®System, NEMOCOsrl).

研究工具

Experimental: Vibration Group (VG)
VG participants undergo rMV treatment, carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (for each treated limb), interspersed with a 5-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle
Sham Comparator: Control Group (CG)
CG participants undergo the sham rMV by positioning the vibrator close to the tendon but without touching the skin. In this condition, patients were only subject to the faint buzzing sound of the vibrator. Sham rMV treatment is carried out for three consecutive days by 2 trained physiatrists; each daily session consists of three 10-minute treatment (for each treated limb), interspersed with a 5-minute break. During the rMV, subjects are required to make a voluntary isometric contraction of the treated muscle

招募信息

招募状态 ^ICMJE

Active, not recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 31, 2019

预计主要完成日期

July 1, 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - age >18, - first ever stroke detected by Magnetic Resonance Imaging (MRI) or Computer Tomography (CT) scan - ischemic or hemorrhagic stroke within 72 hours from symptom onset - motor deficit of the upper and/or lower limb; - ability to perform at least a minimal isometric voluntary contraction of the affected limb Exclusion Criteria: - TIA, or rapidly improving stroke - cerebral venous thrombosis - patients presenting with aphasia, neglect, or apraxia

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Italy

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Vittorio Di Piero，University of Roma La Sapienza

研究赞助商 ^ICMJE

University of Roma La Sapienza

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Vittorio Di Piero, Prof Università di Roma La Sapienza

PRS 账户

University of Roma La Sapienza

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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