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

NCT03863678 | Completed

• 1 other identifier: KK 1695
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; CVA (Cerebrovascular Accident)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Nine Hole Peg Test

  At the baseline and at the end of 4 weeks

• 10 Meter Walking 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 Arms (2)

Neurodevelopmental therapy

EXPERIMENTAL

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

Other: Neurodevelopemental therapy (NDT)

Neurodevelopemental therapy and dry needling therapy

EXPERIMENTAL

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

Other: Neurodevelopemental therapy (NDT) and dry needling

Interventions

Neurodevelopemental therapy (NDT) OTHER

NDT treatment will be given for 45 minutes, 3 sessions per week in 4 weeks period (total of 12 sessions).

Neurodevelopmental therapy

Neurodevelopemental therapy (NDT) and dry needling OTHER

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.

Neurodevelopemental therapy and dry needling therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

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

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Gozde Iyigün, PhD

  Eastern Mediterranean University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc Physiotherapist

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: March 5, 2019
• Study Start: May 12, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Locations

CY (1)