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

Primary Purpose

Post-stroke Upper Limb Spasticity

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Upper Limb Spasticity focused on measuring Muscle Spasticity, Stroke, Stroke Rehabilitation, Nerve Block, Dry Needling, Transcranial Direct Current Stimulation, Electric Stimulation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of São Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Protocol Group (PG)

Sham Group (SG)

Arm Description

The PG received the following combination of four therapeutic modalities twice a week for five weeks: 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.

Outcomes

Primary Outcome Measures

Modified Ashworth scale
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)
To measure patients pain after the interventions. Minimun value = 0 (Painless); Maximum value = 10 (painful)
Functional independence measure (FIM)
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)
Quality of Life - SF-36 questionnaire
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)

Secondary Outcome Measures

Full Information

First Posted
June 6, 2023
Last Updated
July 3, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05940805
Brief Title
Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
Official Title
A Randomized Controlled Trial to Evaluate a Comprehensive Protocol With Four Therapeutic Modalities for the Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 3, 2019 (Actual)
Primary Completion Date
August 12, 2023 (Anticipated)
Study Completion Date
December 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Upper Limb Spasticity
Keywords
Muscle Spasticity, Stroke, Stroke Rehabilitation, Nerve Block, Dry Needling, Transcranial Direct Current Stimulation, Electric Stimulation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
The Sham Group 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. Blinded examiners evaluated patients at baseline, one week post-treatment and three months post-treatment.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protocol Group (PG)
Arm Type
Experimental
Arm Description
The PG received the following combination of four therapeutic modalities twice a week for five weeks: Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES).
Arm Title
Sham Group (SG)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
Intervention Description
Low-frequency transcranial electrical stimulation (2/100 Hz) applied through 0.3-mm-diameter and 40-mm-long needles placed subcutaneously on the scalp at the projection of Penfield's motor homunculus and sensory and frontal supplementary motor associative areas. Paraspinous block at the levels of the C5, C6 and C7 vertebrae concordant with spasticity laterality. Dry needling of spastic upper limb muscles, as identified through a thorough physical examination, using 0.3-mm-diameter and 40-mm-long needles. Muscular functional electrical stimulation (FES) in the antagonists of the upper limb muscles with spasticity with the following parameters: 20-Hz frequency, 300-µs pulse width, zero-second ramp time, 5-second stimulation time, and 5-second resting time.
Intervention Type
Procedure
Intervention Name(s)
SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Ashworth scale
Description
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)
Time Frame
3 months
Title
Visual analogue scale (VAS)
Description
To measure patients pain after the interventions. Minimun value = 0 (Painless); Maximum value = 10 (painful)
Time Frame
3 months
Title
Functional independence measure (FIM)
Description
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)
Time Frame
3 months
Title
Quality of Life - SF-36 questionnaire
Description
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)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of São Paulo General Hospital
City
São Paulo
ZIP/Postal Code
05403010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://accessmedicine.mhmedical.com/content.aspx?bookid=2129&sectionid=192531947.
Description
Cerebrovascular Diseases
URL
https://accessmedicine.mhmedical.com/book.aspx?bookID=3081
Description
Tierney LM, Mcohee SJ, Papadakis MA. Current Medical Diagnosis & Treatment. 44 ed. New York: Mc Graw Hill; 2005
URL
http://www.projetodiretrizes.org.br/projeto_diretrizes/048.pdf
Description
Projeto Diretrizes da Associação Médica Brasileira e Conselho Federal de Medicina - Diagnóstico e Tratamento da Espasticidade. 2001.

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

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