Laser Transcranial and Neuromuscular Electrical Stimulation (LTNMES)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
transcranial laser stimulation associated with NMES
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke; photobiomodulation, Electrical Stimulation
Eligibility Criteria
Inclusion Criteria:
- Female and male aged between 35 and 75 years with hemiplegia after stroke (more than 12 months from onset) as well as those who experienced only one episode of stroke.
Exclusion Criteria:
- Bedridden stroke patients, who had great difficulty standing and walking, psychiatric illnesses, endocrinopathies, heart diseases, severe osteoporosis, cancer, musculoskeletal injuries or disorders in the last six months as well as practitioners of regular physical activity, physical therapy or occupational therapy.
Sites / Locations
- Fernanda Rossi Paolillo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Transcranial Laser and Electrical Stimulation
Placebo
Arm Description
Hemiplegics treated with transcranial laser stimulation (on) associated with neuromuscular electrical stimulation (NMES) (on)
Hemiplegics treated with placebo transcranial laser stimulation (off) associated with NMES (on)
Outcomes
Primary Outcome Measures
Subjective pain scale
Visual Analogue Scales (VAS) of pain intensity
Cognitive status
Mini-Mental State Examination
Secondary Outcome Measures
Grip strength
Hand dynamometer
Gross manual dexterity
Box and block test
Dynamic balance
Timed Up and Go (TUG) test
Spasticity
Ashworth Scale
Functional status
Functional Independence Measure Scale™ (FIM)
Quality of Life status
World Health Organization Quality of Life-Abbreviated form (WHOQOL-BREF)
Well-Being status
Subjective Well-Being Scale (EBES)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05497791
Brief Title
Laser Transcranial and Neuromuscular Electrical Stimulation
Acronym
LTNMES
Official Title
The Effects of Transcranial Laser Stimulation and Neuromuscular Electrical Stimulation in The Treatment of Post-Stroke Dysfunctions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
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 main aim of our study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients. We performed a clinical trial.
Detailed Description
Post-stroke sequelae includes loss functions, such as cognitive and sensory-motor which lead to emotional and social problems, reducing quality of life and well-being. The main aim of our study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients. Our clinical trial showed improvement of cognitive function, pain relief, greater manual dexterity, enhancement of physical and social-emotional health which lead to better quality of life and well-being. There was also increased temperature in the treated regions with laser and NMES. Therefore, transcranial laser stimulation associated with NMES can be an important therapeutic resource for rehabilitation after stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke; photobiomodulation, Electrical Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized and placebo-controlled.
Masking
Investigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Transcranial Laser and Electrical Stimulation
Arm Type
Experimental
Arm Description
Hemiplegics treated with transcranial laser stimulation (on) associated with neuromuscular electrical stimulation (NMES) (on)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Hemiplegics treated with placebo transcranial laser stimulation (off) associated with NMES (on)
Intervention Type
Device
Intervention Name(s)
transcranial laser stimulation associated with NMES
Intervention Description
The cluster was applied on the skin covering the head. NMES of the paretic limbs was programmed to generate, alternately, ankle dorsiflexion and wrist extension.
The NMES was started, after 5 minutes the transcranial laser stimulation (active or placebo-treatment) was started. Then, the therapies were combined. After finishing the transcranial laser stimulation (active or placebo-treatment), the NMES was continued until completing 30 minutes.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The transcranial laser was applied identically for all groups, but the null dose was used in the placebo group. NMES of the paretic limbs was programmed to generate, alternately, ankle dorsiflexion and wrist extension.
Primary Outcome Measure Information:
Title
Subjective pain scale
Description
Visual Analogue Scales (VAS) of pain intensity
Time Frame
3 months
Title
Cognitive status
Description
Mini-Mental State Examination
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Grip strength
Description
Hand dynamometer
Time Frame
3 months
Title
Gross manual dexterity
Description
Box and block test
Time Frame
3 months
Title
Dynamic balance
Description
Timed Up and Go (TUG) test
Time Frame
3 months
Title
Spasticity
Description
Ashworth Scale
Time Frame
3 months
Title
Functional status
Description
Functional Independence Measure Scale™ (FIM)
Time Frame
3 months
Title
Quality of Life status
Description
World Health Organization Quality of Life-Abbreviated form (WHOQOL-BREF)
Time Frame
3 months
Title
Well-Being status
Description
Subjective Well-Being Scale (EBES)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female and male aged between 35 and 75 years with hemiplegia after stroke (more than 12 months from onset) as well as those who experienced only one episode of stroke.
Exclusion Criteria:
Bedridden stroke patients, who had great difficulty standing and walking, psychiatric illnesses, endocrinopathies, heart diseases, severe osteoporosis, cancer, musculoskeletal injuries or disorders in the last six months as well as practitioners of regular physical activity, physical therapy or occupational therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda R Paolillo, PhD
Organizational Affiliation
UEMG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fernanda Rossi Paolillo
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13569600
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Laser Transcranial and Neuromuscular Electrical Stimulation
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