StrokeNCT03863678

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

A study testing Neurodevelopemental therapy (NDT) and Neurodevelopemental therapy (NDT) and dry needling in people with Stroke and CVA (Cerebrovascular Accident), run by Eastern Mediterranean University at 1 site in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Stroke, CVA (Cerebrovascular Accident)
What is being tested?: Neurodevelopemental therapy (NDT) and Neurodevelopemental therapy (NDT) and dry needling
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteCyprus
Study dates: 12 May 2019to 1 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Cyprus1 site

Eastern Mediterranean University
Famagusta, North Cyprus Via Mersin 10 Turkey, 99450

Other trials in Cyprus

About this study

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

Read the 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.

Conditions: Stroke, CVA (Cerebrovascular Accident)
Being tested: Neurodevelopemental therapy (NDT), Neurodevelopemental therapy (NDT) and dry needling
Keywords: dry needling, neurodevelopmental therapy, spasticity, balance, functions, independence
Medical subject headings: Stroke, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 needlingOther
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.

Study groups in NCT03863678
Study group	Role	What they receive
Neurodevelopmental therapy	Experimental	Group 1 will only receive Neurodevelopmental therapy (NDT), for 12 sessions. Receives: 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. Receives: Other: Neurodevelopemental therapy (NDT) and dry needling

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: At the baseline and at the end of 4 weeks

Secondary outcomes (4)

Nine Hole Peg Test
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.
Measured: At the baseline and at the end of 4 weeks
10 Meter Walking Test
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.
Measured: At the baseline and at the end of 4 weeks
Fullerton Advanced Balance Scale
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.
Measured: At the baseline and at the end of 4 weeks
Functional Independence Scale
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.
Measured: At the baseline and at the end of 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 20191 Dec 2019

First posted5 Mar 2019
Study start12 May 2019
Primary completion1 Dec 2019
Study completion1 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled study
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03863678
Sponsor's protocol ID: KK 1695
Status last verified: Dec 2019
First submitted: 24 Feb 2019
Last updated: 3 Dec 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03863678
Acronym / sponsor ID: KK 1695
Conditions: Stroke, CVA (Cerebrovascular Accident)
Keywords: dry needling, neurodevelopmental therapy, spasticity, balance, functions, independence
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Eastern Mediterranean UniversityUniversity, hospital or other
Study start: 12 May 2019 (actual)
Primary completion: 1 Dec 2019 (actual)
Study completion: 1 Dec 2019 (actual)
First posted: 5 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized controlled study

Arm	Type	Receives
Neurodevelopmental therapy	Experimental	Other: Neurodevelopemental therapy (NDT)Group 1 will only receive Neurodevelopmental therapy (NDT), for 12 sessions.
Neurodevelopemental therapy and dry needling therapy	Experimental	Other: Neurodevelopemental therapy (NDT) and dry needlingGroup 2 will receive Neurodevelopmental therapy (NDT) and dry needling therapy, for 12 sessions.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neurodevelopemental therapy (NDT)NDT treatment will be given for 45 minutes, 3 sessions per week in 4 weeks period (total of 12 sessions).	Other	Neurodevelopmental therapy
Neurodevelopemental therapy (NDT) and dry needlingNDT 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.	Other	Neurodevelopemental therapy and dry needling therapy

Primary outcome

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.
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.

4 secondary outcomes

Nine Hole Peg Test
Time frame: At the baseline and at the end of 4 weeks
10 Meter Walking Test
Time frame: At the baseline and at the end of 4 weeks
Fullerton Advanced Balance Scale
Time frame: At the baseline and at the end of 4 weeks
Functional Independence Scale
Time frame: At the baseline and at the end of 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gozde Iyigün, PhD study director

Eastern Mediterranean University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range of movement (ROM) measurement (time frame: Change from baseline ROM measurement at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03863678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.