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

Hemiplegia Clinical Trial

— REHELA  

Official title:

Efficacy of Transcranial Laser Therapy for Improving Upper Extremity Functional Recovery in Hemiplegic Patients From Ischemic Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01308216
• Other study ID #: RyC-10
• Status: Terminated
• Phase: Phase 1
• First received: March 3, 2011
• Last updated: April 2, 2012
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: November 2011
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Procedure:
• low level laser therapy procedure
Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.

Locations

Country	Name	City	State
Spain	Hospital Ramon y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Scale	The upper extremity Fugl-Meyer subscale (0-66) considers flexor and extensor synegies as well as reflex activity and coordination and is specific for grading motor impairments.	20 minutes	No
Secondary	Barthel index	Barthel index (0-100) is composed of 10 items and assesses activities related to clothing,nourishment,personal hygiene and transference.	10 minutes	No