Transcranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke (REHELA)

Madrid Health Service

Status and phase: Terminated; Phase 1

Conditions: Hemiplegia

Treatments: Procedure: low level laser therapy procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01308216

RyC-10

Details and patient eligibility

About

The aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program.

Full description

Transcranial laser therapy is applied with an InGa(Al)As diode laser.The laser in automatic scanning is applied over both cerebral hemisphere during 15 sessions. Patients simultaneously performed a program of therapeutic exercises 3 days a week. Outcome measures were the Fugl-Meyer Upper Extremity scale, which assessed upper limb motor function, and the Barthel index, which assessed general functional disability.

Enrollment: 25 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with hemiplegia secondary to cerebral stroke ischemic.
2. Requirement of shaving the scalp area.
3. Initiation of the TLT procedure begins between 70 and 100 days after stroke onset.
4. Informed written consent before enrolling in the study.

Exclusion criteria

1. Hemiplegia secondary to hemorrhagic stroke.
2. Metallic brain implants.
3. Neurodegenerative disorders.
4. Bilateral motor problems.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Transcranial low level laser therapy

Experimental group

Description:

Transcranial laser therapy is applied by automatic scanning over both hemispheres and the patients undergoing also a standard rehabilitation program based on therapeutic exercises.

Treatment:

Procedure: low level laser therapy procedure

Control

Active Comparator group

Description:

The patients undergoing only a standard rehabilitation program based on therapeutic exercises.

Treatment:

Procedure: low level laser therapy procedure