Skip to main content
Clinical Trials/NCT05497791
NCT05497791
Completed
Not Applicable

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

University of Sao Paulo1 site in 1 country18 target enrollmentMay 1, 2019
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Sao Paulo
Enrollment
18
Locations
1
Primary Endpoint
Inertial Sensor
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
December 20, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fernanda Rossi Paolillo

PhD

University of Sao Paulo

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.

Outcomes

Primary Outcomes

Inertial Sensor

Time Frame: 3 months

Angular measurement of the upper and lower limbs using an inertial sensor.

Cognitive status

Time Frame: 3 months

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

Subjective pain scale

Time Frame: 3 months

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.

Secondary Outcomes

  • Grip strength(3 months)
  • Quality of Life status(3 months)
  • Well-Being status(3 months)
  • Functional status(3 months)
  • Gross manual dexterity(3 months)
  • Dynamic balance(3 months)
  • Spasticity(3 months)
  • Thermography(3 months)

Study Sites (1)

Loading locations...

Similar Trials