Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

Completed

Phase N/A Results N/A

Trial Description

Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.

Detailed Description

The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).

Conditions

Interventions

  • Control group Other
    Other Names: control
    Intervention Desc: Physiotherapy and occupational therapy.
    ARM 1: Kind: Experimental
    Label: Control group
    Description: Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
  • Traditional rehabilitation Behavioral
    Intervention Desc: Assisted stretching, shoulder and arm exercises, and functional reaching tasks
    ARM 1: Kind: Experimental
    Label: Experimental group
    Description: Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
    ARM 2: Kind: Experimental
    Label: Control group
    Description: Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).
  • Experimental group Device
    Intervention Desc: Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.
    ARM 1: Kind: Experimental
    Label: Experimental group
    Description: Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from National Institutes of Health Stroke Scale (NIHSS) baseline, immediately post-intervention (3 weeks). Yes
Secondary Change from Visual analogue scale (VAS) baseline, immediately post-intervention (3 weeks). Yes
Secondary Change from Barthel Index (BI) baseline, immediately post-intervention (3 weeks). Yes
Secondary Change from Modified Ashworth Scale (MAS) baseline, immediately post-intervention Yes
Secondary Change from Disabilities of the Arm, Shoulder and Hand (quickDASH) baseline, immediately post-intervention (3 weeks). Yes

Sponsors