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Completed

NCT Number: NCT03207490

Robotics for Rehabilitation of Hand and Fingers After Stroke

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tyromotion GmbH, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suffering from first stroke, ischemic and/or hemorrhagic
  • Score between 1 and 3 at the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale, IT-NIHSS (Pezzella et al. 2009)
  • Score lower than 100 out of a total of 126 at the Functional Independence Measure (FIM) scale.
  • Less than 45 cubes carried in one minute whit the affected hand at the Box and Bocks Test.

Exclusion criteria

  • Non-stabilized fractures
  • Diagnosis of depression
  • Traumatic brain Injury
  • Untreated or drug resistant seizures.
  • Severe ideomotor apraxia
  • Severe neglect
  • Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery).

Treatment and study plan

AMADEO

Device

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

Other names: Robot-assisted therapy for the hand

Primary outcomes

  1. Change at Box and Block Test (BBT)

    Time frame: Before treatment, then 3 weeks after

    Hand dexterity is measured by means of the BBT. The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.

Secondary outcomes

  1. Change at Functional Independence Measure scale (FIM)

    Time frame: Before treatment, then 3 weeks after

    FIM is an 18-item scale that assesses the degree of autonomy in carrying out activities of daily living (total score = 126 points).

  2. Change at Reaching Performance Scale (RPS)

    Time frame: Before treatment, then 3 weeks after

    RPS assesses the ability of subjects to reach an object (a cone). The cone is placed at both 4-cm (close) and 30-cm (far) distance from the subject. The subject is asked to reach and grab the cone if possible. The observer evaluates the quality of reaching instead of the grip strength (Total score = 36 points).

  3. Change at Modified Ashworth Scale (MAS)

    Time frame: Before treatment, then 3 weeks after

    Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points).

  4. Change at Nine Hole Pegboard Test (NHPT)

    Time frame: Before treatment, then 3 weeks after

    NHPT measures the dexterity of the hand. Patient should insert 9 pins in the board. There are 9 pins. The number of pins inserted in 50 sec are registered or if the patient inserted 9 pins, then the time is registered.

  5. Change at Fugl-Meyer Assessment Scale: Upper Extremity Motor Function (F-M UE)

    Time frame: Before treatment, then 3 weeks after

    Motor function of the upper limb is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairiment), 2 (preserved function)

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Registry information

Official study title

sEMG Based-Rehabilitation of Hand and Fingers After Stroke

Acronym: sERF

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2017
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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