Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2021-04-20

Brief Summary

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Stroke is the second leading cause of death, accounting for 11.13 % of total deaths, and the main cause of disability worldwide. The major type of stroke is ischemic, which occurs in about 87% of all stroke cases Stroke has different risk factors, which can be grouped into modifiable and non-modifiable risk factors. Major risk factors for stroke include age, history of cerebrovascular event, smoking, alcohol consumption, physical inactivity, hypertension, diabetes mellitus, cardiovascular diseases, obesity, metabolic syndrome, diet, nutrition, and genetic risk factors. Many new technique used for rehabilitation after stroke includes Constraint-Induced Movement Therapy for Arm or Leg Paralysis, Mirror Therapy for Hand Recovery, Harness the Relentless Force etc. Segmental muscle vibration (SMV) is also a new technique and effective to decrease the hyper-toned muscles spasticity but still less work done on it. SMV with different frequencies have different effects for both flaccid and spastic patients of all 3 stages of stroke. In our study we will work with 60hz and 120hz frequencies to reduce the spasticity of upper limb and improves their functional level.

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Detailed Description

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Evidence strongly suggest that a period of pure sensory stimulation can affect motor corticoids activity excitability.

In 2019 segmental muscle vibration(SMV) used to improve upper extremity functional ability post stroke and concluded that patients in both groups improved significantly after treatment in Barthel index (BI), elbow Range of Motion (ROM) and elbow muscle strength. However muscle tone in elbow joint of hemiplegic upper extremity improved significantly after only in the experimental group. They suggested that with routine physiotherapy with extended exposure SMV will results in significant reduced spasticity and better improved Activities Of Daily Livings (ADLs).

In 2019 a work done with SMV to improve gate performance in patients with foot drop after chronic stroke. Results of this study revealed moderate improvement in mean gate speed, normal side swing velocity, bilateral stride length and normal-side toe off in experimental group. Further studies needed to evaluate the optimal and minimum SMV dosage.

Another study conducted in 2019 to see Results show that processing speed, inhibitory control and attention improved following SMV. But working memory between groups and also not show a association between executive functions course and fall risk, so they suggest further work to examine effects of vibration therapy on executive functions.

In 2014 another therapist highlight the potential use of SMV to modulate electromyographic (EMG) for reaching movement in chronic stroke patients but needs to be confirmed by larger control perspective trials of SMV.

In 2019 combined work done with repetitive focal muscle vibration with physiotherapy to improve the motor function even in very acute phase of stroke and finds it a valid complementary non pharmacological therapy In 2019 another study suggest that Whole Body Vibration (WBV) and Upper and Lower Cycle (ULC) effective upper for upper extremity motor function and grip strength in sub-acute stroke.

In 2019 a study reported the risk factors (vibration injury to hands vascular components, intermediate blanching neurological components and lower back pain for drivers of work machines) and benefits (improvement in bone health and neuromuscular function). So is a room for research to design a balanced WBV protocol.

A study in 2018 did a meta-analysis and compare the effects of WBV in stroke patients and concludes that it is a safe therapeutic method for improving symptoms.

Conditions

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Stroke, Subacute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Treatment

Conventional Treatment includes exercises limbs

Group Type ACTIVE_COMPARATOR

Conventional Treatment

Intervention Type OTHER

These individuals will receive the conventional intervention including the routine rehabilitation therapy like active and passive ROMs, stretching, strengthening of upper limb, balance improvement exercises. Time duration is of 40 minute 3 times per week.

Focal Muscle Vibration (120Hz)

* Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 120 Hz.
* Conventional Treatment

Group Type EXPERIMENTAL

Focal Muscle Vibration (120Hz)

Intervention Type OTHER

These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.

Focal Muscle Vibration (60Hz)

* Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 60 Hz.
* Conventional Treatment

Group Type EXPERIMENTAL

Focal Muscle Vibration (60Hz)

Intervention Type OTHER

These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.

Interventions

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Conventional Treatment

These individuals will receive the conventional intervention including the routine rehabilitation therapy like active and passive ROMs, stretching, strengthening of upper limb, balance improvement exercises. Time duration is of 40 minute 3 times per week.

Intervention Type OTHER

Focal Muscle Vibration (120Hz)

These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.

Intervention Type OTHER

Focal Muscle Vibration (60Hz)

These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Hemiplegic affected side spastic \<3 on the Ashworth scale.
* History of stroke should be \> 6 weeks and \<12 weeks.

Exclusion Criteria

* Individuals with the other neurological deficit
* Diabetic ulcer, infection or amputation of limb
* Serious cardiovascular disease or unstable angina
* Serious orthopedic problem
* Chronic medical problems

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No