Robot-assisted Rehabilitation of the Upper Limb in Acute and Subacute Post-stroke Patients

Completed

Phase N/A Results N/A

Trial Description

The goal of this study is to determine if robot aided rehabilitation therapy can be equivalent to or more effective than conventional rehabilitation therapy at promoting functional recovery of the paretic upper limb in acute and subacute stroke patients.

Detailed Description

The study aims to test a robotic rehabilitation protocol which involves the use of a robotic device (NeReBot) as an alternative to the conventional rehabilitation treatment. NeReBot is a 3-degree-of-freedom robotic device, which can be programmed by the therapist to perform repetitive assistive movements (flexion and extension, adduction and abduction, pronation and supination, circular) of the upper limb (shoulder and elbow), combined with a visual and acoustic display. Acute and subacute stroke patients (≤20 days post-stroke) will be randomized into two groups with a procedure by a computer program: the experimental group (EG) and the control group (CG). Both groups will receive a total daily treatment time of 120 minutes for five days a week and for five weeks. The EG will perform the conventional functional rehabilitation (proprioceptive exercises, verticalization, gait training, paretic hand and wrist mobilization, without mobilizing the proximal paretic arm) and occupational therapy for 80 minutes a day, while the proximal paretic arm will be treated by NeReBot for 40 minutes a day. For the CG, NeReBot therapy is substituted by 40 minutes of conventional mobilization of the proximal paretic arm by the therapist.

Conditions

Interventions

  • Conventional therapy Other
    Intervention Desc: Conventional rehabilitation therapy of the affected arm for five weeks, five times weekly for 120 minutes
    ARM 1: Kind: Experimental
    Label: Experimental Group (EG)
    Description: Group assigned to robot plus conventional therapy
    ARM 2: Kind: Experimental
    Label: Control Group (CG)
    Description: Group assigned to conventional therapy only
  • Robot therapy (NeReBot) Device
    Intervention Desc: Rehabilitation therapy of the affected arm with NeRebot for five weeks, five times weekly for 40 minutes, plus 80 minutes of conventional therapy
    ARM 1: Kind: Experimental
    Label: Experimental Group (EG)
    Description: Group assigned to robot plus conventional therapy

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 (FM-SEC and FM-WH) 7 months No
Primary Motor-Functional Independence Measure (m-FIM) 7 months No
Primary Frenchay Arm Test (FA-T) 7 months No
Secondary Medical Research Council (MRC deltoid, biceps, triceps, wrist flexor, wrist extensor) 7 months No
Secondary Modified Ashworth Scale (MAS) 7 months No
Secondary Functional Independent Measure (FIM) 7 months No
Secondary Fatigue Severity Scale (FSS) 7 months No
Secondary Upper-Motricity Index (upMI) 7 months No
Secondary Trunk Control Test (TCT) 7 months No
Secondary Short Form 12 7 months No
Secondary Box and Block Test 7 months No

Sponsors