Stroke, Measurement and Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-12-20

Brief Summary

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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.

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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 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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized and placebo-controlled.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Experimental Transcranial Laser and Electrical Stimulation

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

Group Type EXPERIMENTAL

transcranial laser stimulation associated with NMES

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes