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

• ClinicalTrials.gov Identifier: NCT03863678
• Recruitment Status: Completed
• First Posted: March 5, 2019
• Last Update Posted: December 3, 2019
• Sponsor: Eastern Mediterranean University
• Information provided by (Responsible Party): Kübra Küçüktepe, Eastern Mediterranean University

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.

Condition or disease	Intervention/treatment	Phase
Stroke; CVA (Cerebrovascular Accident)	Other: Neurodevelopemental therapy (NDT); Other: Neurodevelopemental therapy (NDT) and dry needling	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 12, 2019
• Actual Primary Completion Date: December 1, 2019
• Actual Study Completion Date: December 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Neurodevelopmental therapy; Group 1 will only receive Neurodevelopmental therapy (NDT), for 12 sessions.	Other: Neurodevelopemental therapy (NDT); NDT treatment will be given for 45 minutes, 3 sessions per week in 4 weeks period (total of 12 sessions).
Experimental: Neurodevelopemental therapy and dry needling therapy; Group 2 will receive Neurodevelopmental therapy (NDT) and dry needling therapy, for 12 sessions.	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 Outcome Measures :

1. Nine Hole Peg Test [ Time Frame: At the baseline and at the end of 4 weeks ]
   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.
2. 10 Meter Walking Test [ Time Frame: At the baseline and at the end of 4 weeks ]
   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.
3. Fullerton Advanced Balance Scale [ Time Frame: At the baseline and at the end of 4 weeks ]
   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.
4. Functional Independence Scale [ Time Frame: At the baseline and at the end of 4 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Cyprus

Eastern Mediterranean University

Famagusta, North Cyprus Via Mersin 10 Turkey, Cyprus, 99450

Sponsors and Collaborators

Eastern Mediterranean University

Investigators

• Study Director: Gozde Iyigün, PhD; Eastern Mediterranean University

More Information

• Responsible Party: Kübra Küçüktepe, Msc Physiotherapist, Eastern Mediterranean University
• ClinicalTrials.gov Identifier: NCT03863678
• Other Study ID Numbers: KK 1695
• First Posted: March 5, 2019
• Last Update Posted: December 3, 2019
• Last Verified: December 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kübra Küçüktepe, Eastern Mediterranean University:

dry needling; neurodevelopmental therapy; spasticity; balance; functions; independence

Additional relevant MeSH terms:

Muscle Spasticity; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations