Robotics for Rehabilitation of Hand and Fingers After Stroke "sERF"

Recruiting

Phase Early 1 Results N/A

Trial Description

The major issue for a person who has suffered a stroke is the severe impairment affecting the hand and the high risk to have a poor recovery associated. Innovative approaches are needed in the next future, translating recent advances from neuro-engineering, into feasible devices for rehabilitation care. The FP7-EU project MYOSENS aims to translate known motor control logic from sEMG prosthetic control, to rehabilitation robotics. The target is to promote the closing of sensory-motor loop on the basis of intention to move, as detected from residual sEMG (i.e. Extensor Digitorum Communis, Flexor Digitorum Profundus).

Detailed Description

The objectives of this pilot study are:
- to assess whether a clinical and kinematic effect might be induced providing a closed-loop control by sEMG signal for robot (i.e. Amadeo ®) assisted therapy of hand function
- to determine safety and feasibility of including robotic therapy into daily rehabilitation programs after stroke.
A total of 20 patients has been recruited, all of them received on daily basis 1 hour of robot therapy in adjunction to 1 hour of standard therapy. Overall the hour of robotic therapy include both subject preparation (15 minutes to place surface electrodes on the forearm and set the right position of sitting and upper limb) and delivery of exercises. The treatment protocol includes passive and active training of flexion and extension movements of the fingers. The passive part lasts 5 minutes, while the active one provides 25 total minutes divided into 5 exercises. The robot therapy lasts 15 consecutive sessions, 5 times a week, for 3 weeks.

Conditions

Interventions

  • AMADEO Device
    Other Names: Robot-assisted therapy for the hand
    Intervention Desc: Robot therapy: 1-Degrees-Of-Freedom (1DOFs) robot training for flexion and extention movements of the hand. Standard rehabilitation therapy includes speech, physical, occupational therapies and group activities
    ARM 1: Kind: Experimental
    Label: Robot group
    Description: Receive 1 hour of AMADEO (robot-assisted therapy) for the hand and 1 hour of daily standard rehabilitation therapy

Outcomes

Type Measure Time Frame Safety Issue
Primary Change at Box and Block Test (BBT) Before treatment, then 3 weeks after
Secondary Change at Functional Independence Measure scale (FIM) Before treatment, then 3 weeks after
Secondary Change at Reaching Performance Scale (RPS) Before treatment, then 3 weeks after
Secondary Change at Modified Ashworth Scale (MAS) Before treatment, then 3 weeks after
Secondary Change at Nine Hole Pegboard Test (NHPT) Before treatment, then 3 weeks after
Secondary Change at Fugl-Meyer Assessment Scale: Upper Extremity Motor Function (F-M UE) Before treatment, then 3 weeks after

Sponsors