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

Primary Purpose

Stroke, CVA (Cerebrovascular Accident)

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Neurodevelopemental therapy (NDT)
Neurodevelopemental therapy (NDT) and dry needling
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring dry needling, neurodevelopmental therapy, spasticity, balance, functions, independence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neurodevelopmental therapy

Neurodevelopemental therapy and dry needling therapy

Arm Description

Group 1 will only receive Neurodevelopmental therapy (NDT), for 12 sessions.

Group 2 will receive Neurodevelopmental therapy (NDT) and dry needling therapy, for 12 sessions.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 24, 2019
Last Updated
December 1, 2019
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT03863678
Brief Title
Effects of Dry Needling on Spasticity, Functions, Balance and Independence Level in Patients With Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 12, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, CVA (Cerebrovascular Accident)
Keywords
dry needling, neurodevelopmental therapy, spasticity, balance, functions, independence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurodevelopmental therapy
Arm Type
Experimental
Arm Description
Group 1 will only receive Neurodevelopmental therapy (NDT), for 12 sessions.
Arm Title
Neurodevelopemental therapy and dry needling therapy
Arm Type
Experimental
Arm Description
Group 2 will receive Neurodevelopmental therapy (NDT) and dry needling therapy, for 12 sessions.
Intervention Type
Other
Intervention Name(s)
Neurodevelopemental therapy (NDT)
Intervention Description
NDT treatment will be given for 45 minutes, 3 sessions per week in 4 weeks period (total of 12 sessions).
Intervention Type
Other
Intervention Name(s)
Neurodevelopemental therapy (NDT) and dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of movement (ROM) measurement
Description
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.
Time Frame
Change from baseline ROM measurement at 4 weeks
Title
Modified Ashworth Scale (MAS)
Description
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.
Time Frame
At the baseline and at the end of 4 weeks
Secondary Outcome Measure Information:
Title
Nine Hole Peg Test
Description
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.
Time Frame
At the baseline and at the end of 4 weeks
Title
10 Meter Walking Test
Description
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.
Time Frame
At the baseline and at the end of 4 weeks
Title
Fullerton Advanced Balance Scale
Description
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.
Time Frame
At the baseline and at the end of 4 weeks
Title
Functional Independence Scale
Description
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.
Time Frame
At the baseline and at the end of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gozde Iyigün, PhD
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Study Director
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
State/Province
North Cyprus Via Mersin 10 Turkey
ZIP/Postal Code
99450
Country
Cyprus

12. IPD Sharing Statement

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

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