Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
- Conditions
- Post-stroke Upper Limb Spasticity
- Interventions
- Procedure: Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)Procedure: SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
- Registration Number
- NCT05940805
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
The general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. The specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol compared with those in the patients who underwent sham interventions.
- Detailed Description
Background: Managing post-stroke upper limb spasticity is a major challenge in the rehabilitation field. The objective of this study was to evaluate the efficacy of a comprehensive treatment protocol with four therapeutic modalities in the recovery of patients with chronic stroke by evaluating clinical, neurological and functional outcomes.
Methodology: Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Age older than 18 years;
- Diagnosis of ischemic or hemorrhagic stroke at least six months previously;
- Presence of single upper limb spasticity
- Spasticity due to conditions other than stroke;
- Hypersensitivity to lidocaine;
- Use of cardiac pacemakers;
- Presence of coagulation disturbances;
- Insufficient perceptual and cognitive capacity to understand the proposed treatment and answer the questionnaires
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protocol Group (PG) Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) The PG received the following combination of four therapeutic modalities twice a week for five weeks: 1. Low-frequency transcranial electrical stimulation; 2. Paraspinous block; 3. Dry needling of spastic upper limb muscles; 4. Muscular functional electrical stimulation (FES). Sham Group (SG) SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) The Sham Group also received the four modalities of the intervention, but these modalities were all inactive. For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used. The patients were blinded to their assigned treatment group.
- Primary Outcome Measures
Name Time Method Quality of Life - SF-36 questionnaire 3 months To measure patients' quality of life after the interventions for each domain. Minimum value (for each domain) = 0 (bad quality of life); Maximum value for each domain = 100 (good quality of life)
Modified Ashworth scale 3 months To measure spasticity, and shoulder, elbow and wrist active and passive goniometry was performed to measure range of motion improvement. Minimum value = 0 (No increase in tone); Maximum value = 4 (Affected part in rigid flexion and extension)
Visual analogue scale (VAS) 3 months To measure patients pain after the interventions. Minimun value = 0 (Painless); Maximum value = 10 (painful)
Functional independence measure (FIM) 3 months To measure independence of patients after the interventions. The Functional Independence Measure (FIM) is a functional assessment with 18 items in the areas of personal care, sphincter control, mobility, communication and social-cognition, through a broad questionnaire. Minimun value = 18 (total dependence); maximum value = 126 (total independence)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of São Paulo General Hospital
🇧🇷São Paulo, Brazil