Laser Transcranial and Neuromuscular Electrical Stimulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Transcranial Laser Stimulation and Neuromuscular Electrical Stimulation in The Treatment of Post-Stroke Dysfunctions

Conditions
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Stroke

Intervention / Treatment
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* Device: transcranial laser stimulation associated with NMES
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized and placebo-controlled.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Transcranial Laser and Electrical Stimulation<br>Hemiplegics treated with transcranial laser stimulation (on) associated with neuromuscular electrical stimulation (NMES) (on) | Device: transcranial laser stimulation associated with NMES<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Hemiplegics treated with placebo transcranial laser stimulation (off) associated with NMES (on) | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective pain scale | Visual Analogue Scales (VAS) of pain intensity | 3 months | 
| Cognitive status | Mini-Mental State Examination | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Hand dynamometer | 3 months | 
| Gross manual dexterity | Box and block test | 3 months | 
| Dynamic balance | Timed Up and Go (TUG) test | 3 months | 
| Spasticity | Ashworth Scale | 3 months | 
| Functional status | Functional Independence Measure Scale™ (FIM) | 3 months | 
| Quality of Life status | World Health Organization Quality of Life-Abbreviated form (WHOQOL-BREF) | 3 months | 
| Well-Being status | Subjective Well-Being Scale (EBES) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke; photobiomodulation, Electrical Stimulation