Ischemic Stroke Clinical Trial
Official title:
Changes in Clinical Outcomes After Application of Physical Therapy and Dry Needling Intervention in Stroke Patients
Verified date | November 2019 |
Source | Universidad Rey Juan Carlos |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators aim to determine if dry needling technique in a non myofascial trigger point area generate the same changes in spasticity, function and pain responses as with dry needling in a myofascial trigger point area.
Status | Completed |
Enrollment | 18 |
Est. completion date | November 6, 2019 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 81 Years |
Eligibility |
Inclusion Criteria: - Medical diagnosis of unilateral ischemic Stroke - Unilateral hemiplegia resulting from Stroke - Evolution of at least 6 months since the Stroke - Age between 35 and 81 years of age - Presence of hypertonia in the upper extremity - Restricted shoulder range of motion 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 - Cognitive deficits - Progressive or severe neurological diseases, eg, heart conditions, unstable hypertension, fractures or implants in upper extremity - Belonephobia (fear to needles) - Have received pharmacological treatment for shoulder pain 3 months before the study - Existence of peripheral nerve injury - Previous history of fracture in the gleno-humeral joint - Episodes of epilepsy in the year prior to participation in the study |
Country | Name | City | State |
---|---|---|---|
Spain | Polibea Sur neurorehabilitation clinic | Madrid | Alcorcón/Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Rey Juan Carlos |
Spain,
Mendigutia-Gómez A, Martín-Hernández C, Salom-Moreno J, Fernández-de-Las-Peñas C. Effect of Dry Needling on Spasticity, Shoulder Range of Motion, and Pressure Pain Sensitivity in Patients With Stroke: A Crossover Study. J Manipulative Physiol Ther. 2016 Jun;39(5):348-358. doi: 10.1016/j.jmpt.2016.04.006. Epub 2016 May 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in spasticity before and after the intervention | It will be measured using the Modified Ashworth Scale. The Modified Ashworth Scale evaluates the muscle tone in patients with central nervous system lesions. It consists of 5 ordinal categories: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder less than half of the range of motion), 2 (more marked increase in muscle tone through most of the range of motion, but affected parts easily moved), 3 (considerable increase in muscle tone, passive movement difficult) and 4 (the part affects this rigid extension or flexion). | Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention | |
Secondary | Changes in shoulder pain before and after the intervention | Numerical Pain Rating Scale (NPRS, 0,10) The Numerical Pain Rating Scale evaluates the intensity of pain perceived between 0 (absence of pain) and 10 (maximum intensity of inimaginable pain). | Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention | |
Secondary | Changes in Function of the Upper Extremity before and after the intervention | Upper limb function will be measured using both Motor Evaluation Scale for Upper Extremity in Stroke patients (MESUPES) and the reaching performance scale (RPS). The MESUPES includes eight items with six response categories (scores 0-5), and nine hand items with three response categories (scores 0-2). The total score of this scale is 58 points. The RPS evaluates 6 components. Four components are related to reaching close and far targets: trunk displacement, movement smoothness, shoulder movements, and elbow movements. The 2 additional components globally rate the quality of prehension and the accomplishment of the task. The total score of this scale is 18 points. |
Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention |
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