Effects of Dry Needling on Spasticity, Functions, Balance and Independence Level in Patients With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863678
• Other study ID #: KK 1695
• Status: Completed
• Phase: N/A
• Start date: May 12, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• CVA (Cerebrovascular Accident)
• Muscle Spasticity
• Stroke

Intervention

Other:
• Neurodevelopemental therapy (NDT)
NDT treatment will be given for 45 minutes, 3 sessions per week in 4 weeks period (total of 12 sessions).
• Neurodevelopemental therapy (NDT) and dry needling
NDT treatment will be given for 45 minutes, 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, 60 seconds (sec) for each muscle groups at the end of the NDT treatment.

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta	North Cyprus Via Mersin 10 Turkey

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of movement (ROM) measurement	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.	Change from baseline ROM measurement at 4 weeks
Primary	Modified Ashworth Scale (MAS)	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.	At the baseline and at the end of 4 weeks
Secondary	Nine Hole Peg Test	NHPT (Nine Hole Peg Test); It is a time test in which the thin hand skill is quantitatively measured. During the test, the patient sits on the table where the nine hole board is located and closes the empty hole with the wooden or plastic bars.	At the baseline and at the end of 4 weeks
Secondary	10 Meter Walking Test	The walking speed of the patients will be measured with a ten-meter walking test (10MWT). The walking time of the patient in 10 meters is recorded in seconds and the walking speed in m / s is calculated.	At the baseline and at the end of 4 weeks
Secondary	Fullerton Advanced Balance Scale	He will use a total of 10 items of balance scale to assess the balance of the patients. Each item is rated between 0-4. It will be evaluated over 40 points.	At the baseline and at the end of 4 weeks
Secondary	Functional Independence Scale	It is a generic and global activity scale and shows how independent it is in daily basic, physical and cognitive activities.Each item is scored at seven levels (1-7), Level 1: Total Assistance, Level 7: Indicates full independence. The total FIM score may vary between 18-126. FIM is the most frequently used activity scale in the world in medical rehabilitation.	At the baseline and at the end of 4 weeks