Stroke, Measurement and Rehabilitation (LTNMES)

Stroke, Measurement and Rehabilitation With Transcranial Laser Stimulation Plus Neuromuscular Electrical Stimulation

The main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: transcranial laser stimulation associated with NMES; Other: Placebo

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 the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients. The 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil, 13569600
      • Fernanda Rossi Paolillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inertial Sensor	Angular measurement of the upper and lower limbs using an inertial sensor.	3 months
Subjective pain scale	Visual Analogue Scales (VAS) of pain intensity: A continuous scale comprised of a horizontal line with 10 cm in length without numeric value was used. The patients were instructed to make a mark with a pen at any point on the line between 2 verbal descriptors, one for each symptom extreme ["No pain" (0) and "as bad as it could be" or "worst imaginable pain]. A ruler was used to measure distance to determine a score.	3 months
Cognitive status	Mini-Mental State Examination: It comprises 11-question to evaluated 5 areas of cognitive function: orientation, registration, attention and calculation, memory, and language. MMSE scores range between 0 and 30, with higher scores reflecting better performance	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip strength	Hand dynamometer: Grip strength of the paretic limb was measured by the hand dynamometer with patients sitting with the shoulder in a neutral position and the elbow flexed at 90°. The average force of three measurements was calculated	3 months
Gross manual dexterity	Box and block test: Gross manual dexterity of the paretic member was measured by the box and block test. The patient must attempt to transport the maximum number of blocks from one compartment of a box to another within 1 minute by grasping each block and transporting it over the partition.	3 months
Dynamic balance	Timed Up and Go (TUG) test: Patients were required to stand up from a chair, walk 3m, turn around, return to the chair, and sit down. The time taken to complete this task was measured with a stopwatch.	3 months
Spasticity	Ashworth Scale: It is 6-point rating scale for measuring muscle tone, with ratings from 0 ("no increase in tone") to 4 ("limb rigid in flexion or extension").	3 months
Functional status	Functional Independence Measure Scale™ (FIM): It is an instrument which comprises 18 subscales measuring a variety of physical and cognitive functions. Each subscale is scored from 1 (total assist) to 7 (complete independence), resulting in a total score that ranges from 18 to 126.	3 months
Quality of Life status	World Health Organization Quality of Life-Abbreviated form (WHOQOL-BREF): a 26-item questionnaire in which items are rated on a 5-point scale. It evaluates 4 domains related to physical factors, psychological factors, social relationships, and environmental context. Higher scores indicate a better quality of life.	3 months
Well-Being status	Subjective Well-Being Scale (EBES): It is composed of 62 items related to three factors that evaluate subjective well-being: positive affect; negative affection and satisfaction with life versus life dissatisfaction. The first 47 items measure positive and negative affect using a 5-point scale with ratings from "not at all" to "to a great extent". The last 22 items measure life satisfaction (or dissatisfaction) using a 5-point scale with ratings from "strongly disagree" to "strongly agree".	3 months
Thermography	Cutaneous temperatures were measurements at 2 regions of the head [parietal (with hair) and frontal (without hair) regions] and 6 points on upper and lower limbs.	3 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Fernanda R Paolillo, PhD, UEMG

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Electrical Stimulation; Photobiomodulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STROkE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No