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Completed

NCT Number: NCT03863678

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

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.

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Key information

Conditions

Stroke Brain Diseases CVA (Cerebrovascular Accident) Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Mediterranean University

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurodevelopemental therapy (NDT)

Other

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

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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