StrokeNCT02579291
Dry Needling in Patients Who Had Experience Stroke
A study testing Dry needling and Bobath in people with Stroke, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Individuals who had experience a stroke usually suffer from spasticity at medium and long-terms. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Dry needling and Bobath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to May 2016
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- First-ever unilateral stroke;
- hemiplegia resulting from stroke;
- unilateral equinovarus gait with independent walk;
- able to ambulate without supporting devices
Who cannot join
- recurrent stroke;
- previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with BTX-A in the previous 6 months
- not independent in the basic activities of daily living
- cognitive deficits;
- progressive or severe neurologic diseases;
- fear to needles;
- any contraindication for dry needling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Spasticity, Motor Function and Stabilometry After Dry Needling of the Tibialis Posterior Muscle in Post-stroke Patients
Individuals who had experience a stroke usually suffer from spasticity at medium and long-terms. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. A recent study has proposed the use of dry needling for improving spasticity in the lower extremity. No study has investigated the effects of deep dry needling inserted into spastic musculature in stabilometry and moto function in patients who had experience a stroke. A randomized controlled trial investigating the effects of the inclusion of deep dry needling into a Bobath interventional program on spasticity, motor function and balance (stabilometry) in individuals who had experience a stroke
- Conditions
- Stroke
- Being tested
- Dry needling, Bobath
- Keywords
- Stroke, Dry needling, Spasticity, Motor function, Stabilometry
- 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.
Dry needlingOther
Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.
BobathOther
Patients will receive different neuromodulatory interventions based on the Bobath concept with the aim to decrease spasticity on the lower extremity
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | The experimental group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system. In addition, this group will receive a single session of dry needling into the tibialis posterior muscle with a disposable stainless steel needle (0.3mm x 50mm) Receives: Other: Dry needling |
| Bobath | Active comparator | This group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system. Receives: Other: Bobath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in spasticity before and 10 minutes after the intervention
Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively will move the ankle in dorsal-flexion direction, back and forth at least 5 times and will evaluate the degree of resistance to the movement on a scale from 0-4.
Measured: Baseline and immediate after the intervention
Secondary outcomes (2)
Changes in motor function before and 10 minutes after the intervention
The Fugl-Meyer evaluation will be used to determine motor impairments and physical recovery of patients who had experienced a stroke
Measured: Baseline and immediate after the intervention
Changes in stabilometry outcomes before and 10 minutes after the intervention
The time reaction will be assessed as stabilometric data from each patient.
Measured: Baseline and immediate after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- CESAR FERNANDEZ-DE-LAS-PEÑAS, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579291
- Sponsor's protocol ID
- URJC 07-2015
- Status last verified
- May 2016
- First submitted
- 12 Oct 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanchez-Mila Z, Salom-Moreno J, Fernandez-de-Las-Penas C. Effects of dry needling on post-stroke spasticity, motor function and stability limits: a randomised clinical trial. Acupunct Med. 2018 Dec;36(6):358-366. doi: 10.1136/acupmed-2017-011568. Epub 2018 Jul 9.
PubMed 29986902
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Spasticity, Motor Function and Stabilometry After Dry Needling of the Tibialis Posterior Muscle in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT02579291
- Acronym / sponsor ID
- URJC 07-2015
- Conditions
- Stroke
- Keywords
- Stroke, Dry needling, Spasticity, Motor function, Stabilometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Oct 2015 (estimated)
- 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.
Individuals who had experience a stroke usually suffer from spasticity at medium and long-terms. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. A recent study has proposed the use of dry needling for improving spasticity in the lower extremity. No study has investigated the effects of deep dry needling inserted into spastic musculature in stabilometry and moto function in patients who had experience a stroke. A randomized controlled trial investigating the effects of the inclusion of deep dry needling into a Bobath interventional program on spasticity, motor function and balance (stabilometry) in individuals who had experience a stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingThe experimental group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system. In addition, this group will receive a single session of dry needling into the tibialis posterior muscle with a disposable stainless steel needle (0.3mm x 50mm) |
| Bobath | Active comparator | Other: BobathThis group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- First-ever unilateral stroke;
- hemiplegia resulting from stroke;
- unilateral equinovarus gait with independent walk;
- able to ambulate without supporting devices
Key exclusion criteria (7 listed)
- recurrent stroke;
- previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with BTX-A in the previous 6 months
- not independent in the basic activities of daily living
- cognitive deficits;
- progressive or severe neurologic diseases;
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 |
|---|---|---|
| Dry needlingOnce the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds. | Other | Dry needling |
| BobathPatients will receive different neuromodulatory interventions based on the Bobath concept with the aim to decrease spasticity on the lower extremity | Other | Bobath |
Primary outcome
Changes in spasticity before and 10 minutes after the intervention
Time frame: Baseline and immediate after the intervention
Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively will move the ankle in dorsal-flexion direction, back and forth at least 5 times and will evaluate the degree of resistance to the movement on a scale from 0-4.
2 secondary outcomes
Changes in motor function before and 10 minutes after the intervention
Time frame: Baseline and immediate after the intervention
Changes in stabilometry outcomes before and 10 minutes after the intervention
Time frame: Baseline and immediate after the intervention
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 12 May 2016.
- Derived from this study: PubMed 29986902Sanchez-Mila Z, Salom-Moreno J, Fernandez-de-Las-Penas C. Effects of dry needling on post-stroke spasticity, motor function and stability limits: a randomised clinical trial. Acupunct Med. 2018 Dec;36(6):358-366. doi: 10.1136/acupmed-2017-011568. Epub 2018 Jul 9.
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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.
CESAR FERNANDEZ-DE-LAS-PEÑAS principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and Bobath in people with Stroke, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 7 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 12 May 2016. 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 Spain. 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?
Changes in spasticity before and 10 minutes after the intervention (time frame: Baseline and immediate after the intervention). 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 NCT02579291, which also lists 1 linked publication.
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 12 May 2016.