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The effectiveness of radial Extracorporeal Shock Wave Therapy versus Transcutaneous Electrical Nerve Stimulation in the management of upper limb spasticity in chronic post-stroke hemiplegia: A randomized controlled trial

Phase 2
Conditions
stroke
Registration Number
SLCTR/2019/040
Lead Sponsor
niversity of Peradeniya
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

1. Male and female patients aged between 40 to 70 years diagnosed with stroke resulting in hemiplegia more than six months ago
2.Stable spasticity (no variability within two months before recruitment) in upper limb
3. Patients with more than grade three of Modified Ashwath Scale
4. Patients with Voluntary Control Grading from two to four for affected UL
5. Able to maintain standing position for five minutes without manual assistance
6. Able and willing to participate in four weeks study and to sign consent form

Exclusion Criteria

1.Patients with reflex sympathetic dystrophy/ severe shoulder subluxation/ shoulder dislocation/ contracture in the affected UL/ fixed deformity of hand/ shoulder hand syndrome
2.Any neurological disorder or pain that might limits arm movement
3. Patients who have received botox injection or acupuncture within past 6 months to the affected UL
4. Complete sensory loss of upper limb
5. Presence of high risk cardiovascular disorders such as myocardial infarction, heart failure
6. Severe hypertension defined as SBP? 180 and or DBP ? 110
7. Presence of convulsions
8. Patients with visual impairment
9. Patients with behavioral problems
10. Already enrolled in some form of physical therapy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
•Spasticity grading of affected upper limb using Modified Ashwath scale<br>•Voluntary control of affected upper limb according to a grading system<br> [All the subjects will be assessed for spasticity of upper limb and voluntary control of upper limb immediately after the TENS or rESWT treatment has been given, and at the end of the four weeks treatment session eight, twelve, sixteen and twenty weeks after the first treatment ]<br>
Secondary Outcome Measures
NameTimeMethod
•Fugl - Meyer motor assessment of physical performance of upper limb<br>•Action research arm test [All the subjects will be assessed for hand function grading immediately after the TENS or rESWT treatment has been given, at the end of the four weeks treatment session and after eight, twelve, sixteen and twenty weeks after the first treatment ]<br>
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