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

Terminated

Phase 1 Results N/A

Trial Description

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.

Detailed 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.

Trial Stopped: Based in the negative of patients to shave de hair.

Conditions

Interventions

  • Low level laser therapy procedure Procedure
    Other Names: COMBY 3 Terza Serie C-LASER; ASA.
    Intervention Desc: Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.
    ARM 1: Kind: Experimental
    Label: Transcranial low level laser therapy
    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.
    ARM 2: Kind: Experimental
    Label: Control
    Description: The patients undergoing only a standard rehabilitation program based on therapeutic exercises.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Scale 20 minutes No
Secondary Barthel index 10 minutes No

Sponsors