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Clinical Trials/NCT03863678
NCT03863678
Completed
Not Applicable

Effects of Dry Needling on Spasticity, Upper and Lower Extremity Functions, Balance and Independence Level in Addition to Neurodevelopmental Therapy in Patients With Stroke

Eastern Mediterranean University1 site in 1 country42 target enrollmentMay 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Eastern Mediterranean University
Enrollment
42
Locations
1
Primary Endpoint
Range of movement (ROM) measurement
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The aim of this study is to investigate the effects of dry needling method in addition to neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and independence level in patients with stroke who have spasticity.

Detailed Description

The aim of this study is to investigate the effects of dry needling method in addition to neurodevelopmental therapy on spasticity, upper and lower extremity functions, balance and independence level in patients with stroke who have spasticity. In this study, goniometric measurement, Modified Ashworth Scale, Nine Hole Peg Test, 10 Meter Walking Test, Fullerton Advanced Balance Scale and Functional Independence Scale will be used for outcome measurement. The participants will be randomised into two groups; Group 1 will receive NDT and Group 2 will receive both NDT and dry needling therapy. Both groups will be given 45 minutes of NDT, 3 sessions per week in 4 weeks period (total of 12 sessions). Group 2 will also receive dry needling therapy 3 sessions per week in 4 weeks period (total of 12 sessions). Dry needling will be applied on M. Gastrocnemius, M.Quadriceps, M.Flexor Carpi Radialis and M.Biceps Brachii muscles. The application time on each muscle will be 60 seconds (sec). Fast in and fast out technique will be used for dry needling therapy. All patients will be measured before treatment (T1) and after treatment (T3). An inter-measurement will be performed after the treatment session (T2) in addition to T1 and T3 measurements in the Group 2, to evaluate the acute effects of dry needling therapy. No additional treatment will be applied to the Group 1. All assessments will be performed by the same physiotherapist.

Registry
clinicaltrials.gov
Start Date
May 12, 2019
End Date
December 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kübra Küçüktepe

Msc Physiotherapist

Eastern Mediterranean University

Eligibility Criteria

Inclusion Criteria

  • First time stroke,
  • Patients who has spasticity due to stroke,
  • At least 6 months after stroke,
  • Individuals between the ages of 18-75 will be included in the study.

Exclusion Criteria

  • Any contraindication for dry needling (eg, anticoagulants, infections, bleeding, etc.),
  • Having diabetes,
  • Having cardiovascular diseases,
  • Having any other neurological problems,
  • Application of Botox within 6 months prior to the study,
  • Individuals included in another treatment program will not be included in the study.

Outcomes

Primary Outcomes

Range of movement (ROM) measurement

Time Frame: Change from baseline ROM measurement at 4 weeks

Measurement of joint movement of individuals will be done by a goniometer by the same physiotherapist. First passive normal joint movement then active normal joint movement will be evaluated and recorded.

Modified Ashworth Scale (MAS)

Time Frame: At the baseline and at the end of 4 weeks

Modified ashworth scale (MAS) will be used to evaluate the spasticity of upper (elbow flexors flexor carpi radialis) and lower (quadriceps and gastrocnemius) extremity muscles. The MAS assess the level of spasticity on ordinal scale from 0 to 4 based on the level of resistance in response to a quick and passive movement. According to the MAS scale, 0 represents no increase in muscle tone, 1 represents slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension, 1+ represents increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2 represents more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3 represents considerable increase in muscle tone, passive movement difficult and 4 represents affected part(s) rigid in flexion or extension.

Secondary Outcomes

  • 10 Meter Walking Test(At the baseline and at the end of 4 weeks)
  • Nine Hole Peg Test(At the baseline and at the end of 4 weeks)
  • Fullerton Advanced Balance Scale(At the baseline and at the end of 4 weeks)
  • Functional Independence Scale(At the baseline and at the end of 4 weeks)

Study Sites (1)

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