Spasticity, Muscle, Stroke
Conditions
Keywords
stroke, spasticity, shock wave, wrist, finger
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals aged 18 years or older with unilateral cerebral stroke. * Wrist and finger flexor muscle tone with a score greater than 1 on the Modified Ashworth Scale. * Stable medical condition and vital signs. * Conscious and able to comply with instructions.
Exclusion criteria
* History of more than one stroke, traumatic brain injury, or cerebral neoplasm. * Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal diseases affecting muscle tone assessment. * Contraindications for shockwave intervention, such as malignancies, coagulopathies, local infections, or use of cardiac pacemakers. * Undergone shockwave therapy or botulinum toxin injections for post-stroke spasticity in the past three months. * Cognitive, consciousness, or language impairments preventing participation in the intervention or functional assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| passive range of motion for the wrist and finger joints | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | the extent to which a joint can be moved without the patient actively participating in the movement |
| hand grip strength | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | use dynamometer to record the maximum force applied when the patient squeezes it |
| Visual Analogue Scale (VAS) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable |
| modified Ashworth scale (MAS) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | 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. |
| modified Tardieu scale (MTS) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Box and Block Test | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | 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. |
| Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | range from 0 (complete paralysis) to 66 (full function), assessing motor recovery in post-stroke upper extremities |
| Wolf Motor Function Test | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | 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. |
| Action Research Arm Test (ARAT) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | 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. |
| Barthel index | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | 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. |
| Functional Independence Measure (FIM) | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | 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). |
| ultrasound assessment | pre-treatment; 1, 4, 12, and 24 weeks post-treatment | used strain elastography to assess elasticity of forearm muscles |
Countries
Taiwan
Contacts
Primary ContactShu-mei Yang, MD
Outcome results
None listed