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

NCT ID: NCT03863678

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-12

Study Completion Date

2019-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke CVA (Cerebrovascular Accident)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neurodevelopmental therapy

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

Group Type EXPERIMENTAL

Neurodevelopemental therapy (NDT)

Intervention Type OTHER

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

Neurodevelopemental therapy and dry needling therapy

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

Group Type EXPERIMENTAL

Neurodevelopemental therapy (NDT) and dry needling

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurodevelopemental therapy (NDT)

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eastern Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kübra Küçüktepe

Msc Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gozde Iyigün, PhD

Role: STUDY_DIRECTOR

Eastern Mediterranean University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eastern Mediterranean University

Famagusta, North Cyprus Via Mersin 10 Turkey, Cyprus

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Cyprus

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KK 1695

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nerve Transfers in Post-stroke Spasticity
NCT04437056 ENROLLING_BY_INVITATION NA
DDN in Stroke--COBRE
NCT05196737 COMPLETED NA