Clinical trial NCT03863678: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
CVA (Cerebrovascular Accident)
Keywords: dry needling
neurodevelopmental therapy
spasticity
balance
functions
independence
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Range of movement (ROM) measurement
timeFrame: Change from baseline ROM measurement at 4 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: At the baseline and at the end of 4 weeks
Secondary outcomes:
measure: Nine Hole Peg Test
timeFrame: At the baseline and at the end of 4 weeks
measure: 10 Meter Walking Test
timeFrame: At the baseline and at the end of 4 weeks
measure: Fullerton Advanced Balance Scale
timeFrame: At the baseline and at the end of 4 weeks
measure: Functional Independence Scale
timeFrame: At the baseline and at the end of 4 weeks
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
state: North Cyprus Via Mersin 10 Turkey
Study officials:
affiliation: Eastern Mediterranean University
name: Gozde Iyigün, PhD
role: STUDY_DIRECTOR
References: