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Clinical Trials/NCT05952830
NCT05952830
Completed
Not Applicable

Comparison of the Effects of Extracorporeal Shock Wave Therapy and Dry Needing on Spasticity in Poststroke Patients: a Randomized Controlled Trial

Kirsehir Ahi Evran Universitesi2 sites in 1 country20 target enrollmentAugust 21, 2021
ConditionsHemiplegia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
Kirsehir Ahi Evran Universitesi
Enrollment
20
Locations
2
Primary Endpoint
Purdue Pegboard Test (PPT)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. the purpose of this study is the comparative study between effectiveness of external corporeal shockwave therapy (ESWT) and dry needling (DN) on spasticity, pain, and upper limb function and sensation in individuals with hemiplegia.

Methods: In this study, individuals with hemiplegia were randomized 1:1 to parallel ESWT-Group (n = 10) or DN group (CG) (n = 10). Upper Extremity Functions, Sensation, Spasticity and Pain were evaluated. All measurement indicators were be evaluate before treatment and immediately after one session treatment. Mixedmodel repeated measured ANOVAs were then employed to determine if a group*time interaction existed on the effects of the treatment on each outcome variable for each group as the between-subjects variable and time as the within-subjects variables.

Detailed Description

Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. the purpose of this study is the comparative study between effectiveness of external corporeal shockwave therapy (ESWT) and dry needling (DN) on spasticity, pain, and upper limb function and sensation in individuals with hemiplegia. Methods: In this study, individuals with hemiplegia were randomized 1:1 to parallel ESWT-Group (n = 10) or DN group (CG) (n = 10). Upper Extremity Functions, Sensation, Spasticity and Pain were evaluated. All measurement indicators were be evaluate before treatment and immediately after one session treatment. Mixedmodel repeated measured ANOVAs were then employed to determine if a group\*time interaction existed on the effects of the treatment on each outcome variable for each group as the between-subjects variable and time as the within-subjects variables.

Registry
clinicaltrials.gov
Start Date
August 21, 2021
End Date
October 26, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kirsehir Ahi Evran Universitesi
Responsible Party
Principal Investigator
Principal Investigator

Buket Büyükturan

associate professor

Kirsehir Ahi Evran Universitesi

Eligibility Criteria

Inclusion Criteria

  • being between the age of 25-65
  • having been diagnosed with a stroke by a specialist, first time stroke
  • BBM spasticity, ability to understand command actions
  • stable vital signs, unchanged drug doses that might affect muscle spasticity
  • taking no antispastic medication
  • with Modified Ashworth Scale (MAS) score more than 1 and less than 4 for the upper limb flexor tension

Exclusion Criteria

  • received Botox, alcohol or phenol block treatments
  • received elbow joint surgical orthopedic surgery
  • history of epilepsy
  • severe mental disorders
  • malignant tumors; and limb venous thrombosis
  • sensory disturbances
  • the presence of any other neurological disorders
  • currently receiving other treatments
  • ESWT contraindications
  • exhibit fear of needles; or have any contraindication to DN

Outcomes

Primary Outcomes

Purdue Pegboard Test (PPT)

Time Frame: 1 month

: To do PPT, the participant seat on a chair in front of a table while the board is on the table. Nails a washers placed in the holes above the board. After the explanation of the test and letting the participant to practice; the test starts. The patient must put the nails in 30 second in the first 3 test; the maximum number that he or she can is the test result. first with the non affected hand, then with the other hand, and finally with both hands simultaneously from top to bottom. In the final subtest, individuals will use both hands to construct sets of nails and washers in a 60-second period. Finally, the combining score consists of the number of sets of nails and stamps collected (22,23).

Spasticity

Time Frame: 10 minutes

We used modified ashworth scale to test spasticity in elbow flexors while the participants lying supine.

Jebsen Taylor Test of Hand Function (JTHF)

Time Frame: 1 month

To do JTHF the participant seat on a chair in front of a table. The test consist of 7 parts. For the first part (writing) individuals will be given a blank A4 paper and a pen and asked to write a sentence shown to them. For the second part (page turning task), a booklet with A4 paper size pages will be given to the individual and asked to turn 5 pages as fast as possible. For the third part (collecting and dropping small objects), 2 covers, 2 book clips and 2 coins will be used. These materials will be placed on a plate, spaced apart, on the table, right in front of the individual's hand to administer the test.

9 Hole Peg Test

Time Frame: 1 month

To do 9 hole peg test (9-HPT), the participant seat on a chair in front of a table while the board is on the table. the sticks are on the affected hand side of the individuals and the holes are on the non-affected hand side. The participants must place the sticks in holes and then remove them from the holes as quickly as possible After the explanation of the test and letting the participant to practice; the test starts. Test results will be recorded by measuring the time with a stopwatch from the moment individuals touch the first stick until the last stick is inserted into the board (21).

Secondary Outcomes

  • Light Touch(1 month)
  • Visual Anolog Scale(1 month)
  • Tactile Sense(1 month)
  • Pain Sensation(1 month)
  • 2 Point Discrimination(1 month)

Study Sites (2)

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