Stroke, Measurement and Rehabilitation

NCT05497791 | Completed DMC

• 1 other identifier: Stroke
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Photobiomodulation; Electrical Stimulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Grip strength

  3 months

• Gross manual dexterity

  3 months

• Dynamic balance

  3 months

• Spasticity

  3 months

• Functional status

  3 months

Study Arms (2)

Experimental Transcranial Laser and Electrical Stimulation

EXPERIMENTAL

Hemiplegics treated with transcranial laser stimulation (on) associated with neuromuscular electrical stimulation (NMES) (on)

Device: transcranial laser stimulation associated with NMES

Placebo

PLACEBO COMPARATOR

Hemiplegics treated with placebo transcranial laser stimulation (off) associated with NMES (on)

Other: Placebo

Interventions

transcranial laser stimulation associated with NMES DEVICE

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.

Experimental Transcranial Laser and Electrical Stimulation

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Fernanda Rossi Paolillo

São Carlos, São Paulo, 13569600, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Fernanda R Paolillo, PhD

  UEMG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Randomized and placebo-controlled.

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: May 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)