Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.
This study aimed to evaluate the effects of focused Extracorporeal Shock Wave Therapy (ESWT) on upper limb flexor spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific forearm flexor muscles, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions. The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, hand grip strength, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, ultrasound strain elastography, and electromyography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on upper limb function and spasticity in stroke survivors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis.
Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
Taipei, Taipei, Taiwan
RECRUITINGpassive range of motion for the wrist and finger joints
the extent to which a joint can be moved without the patient actively participating in the movement
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
hand grip strength
use dynamometer to record the maximum force applied when the patient squeezes it
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Visual Analogue Scale (VAS)
individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
modified Ashworth scale (MAS)
Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
modified Tardieu scale (MTS)
A standard goniometer will be utilized to measure R2 and R1. The patient will be in testing position according to the muscle to be tested. The stretching velocity of V1 and V3 will be applied to measure R2 and R1, respectively. The quality of muscle reaction will be graded at the stretching velocity of V3 as well. The difference between R2 and R1 will be the measure of the dynamic component of spasticity. The minimum score on the MTS is 0 (no spasticity), and the maximum score is 5 (severe spasticity), for each of the velocities tested.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
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range from 0 (complete paralysis) to 66 (full function), assessing motor recovery in post-stroke upper extremities
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Action Research Arm Test (ARAT)
a standardized measure evaluating upper limb motor ability in stroke patients, scoring from 0 (no movement) to 57 (normal arm function). It assesses grasp, grip, pinch, and gross arm movement.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Barthel index
measures a person's daily living abilities, focusing on ten areas of self-care and mobility. Scores range from 0 to 100, with higher scores denoting greater independence.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Functional Independence Measure (FIM)
assesses a patient's level of disability and tracks changes over time, with a focus on physical and cognitive functioning across 18 items, scored from 18 (total assistance required) to 126 (fully independent).
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
ultrasound assessment
used strain elastography to assess elasticity of forearm muscles
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Box and Block Test
a manual dexterity test where participants transfer wooden blocks from one section of a box to another for one minute using one hand. The score is determined by the number of blocks moved, with minimal scores indicating severe dexterity impairment and higher scores indicating better gross manual dexterity.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Wolf Motor Function Test
assess upper extremity function in individuals with neurological impairments, using 17 tasks divided into sections of time, functional ability, and strength. Scoring is on a 6-point ordinal scale, ranging from 0 ("Does not attempt with upper extremity being tested," indicating severe impairment) to 5 ("Movement appears to be normal," suggesting full functionality). Lower scores indicate greater impairment.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment