Positive Effects of Extracorporeal Shock Wave Therapy on Spasticity in Poststroke Patients: A Meta-Analysis.
Peipei Guo, Fuqiang Gao, Tingting Zhao...
https://pubmed.ncbi.nlm.nih.gov/28918085Actively Recruiting
Led by Teresa Mateu Campos · Updated on 2024-09-19
60
Participants Needed
1
Research Sites
59 weeks
Total Duration
Researchers are evaluating the long-term effects of focused extracorporeal shock wave therapy (fESWT) on muscle spasticity in stroke patients, specifically targeting the spastic equinus foot condition. This study compares whether three sessions of fESWT improve spasticity and functionality for a longer period than a single session. Spasticity is a common and disabling complication after stroke, affecting many globally, and this trial aims to clarify the best approach for treatment duration and effect. Participants will be randomly assigned to one of two groups: one receiving a single session of fESWT, and the other receiving three weekly sessions over three consecutive weeks. The therapy is delivered using a specialized device targeting muscle bellies of the gastrocnemius medial and lateral and soleus, located by ultrasound guidance. The study measures primary and secondary outcomes before treatment and at multiple follow-up points up to 48 weeks after the last session. During the study, participants will be assessed on muscle tone using the Modified Ashworth Scale and other functional and quality of life measures such as ankle motion range, mobility tests, spasm frequency, and stroke quality of life scales. Evaluations occur before treatment and at 1, 4, 8, 12, 20, 24, 36, and 48 weeks afterward. Researchers will monitor adverse events throughout the study, which involves 60 stroke patients with spastic equinus foot who can walk independently or with aids.
CONDITIONS
Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 3 weeks depending on group assignment
Participants receive focused extracorporeal shock wave therapy (fESWT) applied to the gastrocnemius medial, lateral, and soleus muscles. One group receives a single session, while the other group receives 3 weekly sessions over 3 consecutive weeks.
1 to 3 visits (in-person) depending on group assignment
Duration - Up to 48 weeks after the last therapy session
Participants are evaluated periodically after the last session of therapy to assess outcomes such as muscle spasticity, ankle motion, mobility, pain, spasm frequency, and quality of life. Adverse events are monitored throughout this period.
Visits at weeks 1, 4, 8, 12, 20, 24, 36, and 48 after the last session
Total: 1 location
1
Hospital de la Plana
Vila-real, Castellon, Spain, 12540
Actively Recruiting
T
Teresa Mª Mateu Campos
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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