Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

Completed

Phase N/A Results N/A

Trial Description

The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.

Detailed Description

We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.
We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.

Conditions

Interventions

  • Continuous Passive Motion Rehabilitation Device
    Other Names: Continuous Passive Motion device for hand: Gloreha
    Intervention Desc: Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
    ARM 1: Kind: Experimental
    Label: Active range of motion
    Description: The group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.
    ARM 2: Kind: Experimental
    Label: Passive range of motion
    Description: The group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.
  • A-ROM Continuous Passive Rehabilitation Device
    Other Names: Continuous Passive Motion device for hand: Gloreha
    Intervention Desc: Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
    ARM 1: Kind: Experimental
    Label: A-ROM Continuous Passive Rehabilitation
    Description: The group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.
  • P-ROM Continuous Passive Rehabilitation Device
    Other Names: Continuous Passive Motion device for hand: Gloreha
    Intervention Desc: Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
    ARM 1: Kind: Experimental
    Label: P-ROM Continuous Passive Rehabilitation
    Description: The group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline of Perimeter edema 1 day after the treatment No
Secondary Change from Baseline of Visual analogue scale (VAS) 1 day after the treatment No
Secondary Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS) 1 day after the treatment No
Secondary Change from Baseline of Range Of Motion (ROM) 1 day after the treatment No
Secondary Clinical Global Impression (CGI) 1 day after the treatment No

Sponsors