Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients

Not Applicable

Completed

• Conditions: Post-stroke Upper Limb Spasticity

• 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.

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Study Start: 2023-08-03
• Primary Completion: 2023-11-12
• Study Completion: 2023-12-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Age older than 18 years;
• Diagnosis of ischemic or hemorrhagic stroke at least six months previously;
• Presence of single upper limb spasticity

Exclusion Criteria

• 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

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)

Trial Locations

Locations (1)

University of São Paulo General Hospital; 🇧🇷 São Paulo, Brazil