Dry Needling in Patients Who Had Experience Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Bobath
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Dry needling, Spasticity, Motor function, Stabilometry
Eligibility Criteria
Inclusion Criteria:
- First-ever unilateral stroke;
- hemiplegia resulting from stroke;
- unilateral equinovarus gait with independent walk;
- able to ambulate without supporting devices
Exclusion Criteria:
- 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
Sites / Locations
- Cesar Fernandez-de-Las-Peñas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dry needling
Bobath
Arm Description
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)
This group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Changes in stabilometry outcomes before and 10 minutes after the intervention
The time reaction will be assessed as stabilometric data from each patient.
Full Information
NCT ID
NCT02579291
First Posted
October 12, 2015
Last Updated
May 10, 2016
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT02579291
Brief Title
Dry Needling in Patients Who Had Experience Stroke
Official Title
Changes in Spasticity, Motor Function and Stabilometry After Dry Needling of the Tibialis Posterior Muscle in Post-stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Dry needling, Spasticity, Motor function, Stabilometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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)
Arm Title
Bobath
Arm Type
Active Comparator
Arm Description
This group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Bobath
Intervention Description
Patients will receive different neuromodulatory interventions based on the Bobath concept with the aim to decrease spasticity on the lower extremity
Primary Outcome Measure Information:
Title
Changes in spasticity before and 10 minutes after the intervention
Description
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.
Time Frame
Baseline and immediate after the intervention
Secondary Outcome Measure Information:
Title
Changes in motor function before and 10 minutes after the intervention
Description
The Fugl-Meyer evaluation will be used to determine motor impairments and physical recovery of patients who had experienced a stroke
Time Frame
Baseline and immediate after the intervention
Title
Changes in stabilometry outcomes before and 10 minutes after the intervention
Description
The time reaction will be assessed as stabilometric data from each patient.
Time Frame
Baseline and immediate after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First-ever unilateral stroke;
hemiplegia resulting from stroke;
unilateral equinovarus gait with independent walk;
able to ambulate without supporting devices
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CESAR FERNANDEZ-DE-LAS-PEÑAS
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cesar Fernandez-de-Las-Peñas
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29986902
Citation
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.
Results Reference
derived
Learn more about this trial
Dry Needling in Patients Who Had Experience Stroke
We'll reach out to this number within 24 hrs