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Completed

NCT Number: NCT02321254

Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke

The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to determine the feasibility of including robotic therapy in daily rehabilitation programmes, after stroke. Additionally, we aim to investigate the acceptance of this intervention from patients and therapists. A total of 10 patients will be recruited in this study, all the patients will receive 1 hour of standard therapy together with 45 min of robot therapy every day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period of four weeks. Additional 15 minutes are required for placing surface electrodes on the shoulder and patient preparation. The study will include passive and active shoulder training of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35 minutes.

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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–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

FerRobotics Compliant Robot Technology GmbH, Linz, Austria

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients suffering from stroke, ischemic and / or hemorrhagic
  • Stroke in the left hemisphere
  • Score between 1 and 3 in the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale (IT-NIHSS) (Pezzella et al. 2009)
  • Score of the Functional Independence Measure (FIM) scale (Keith et al., 1987) less than 100 out of a total of 126. This scale is used as a reference to indicate the degree of autonomy in carrying out activities of daily living (ADLs)
  • Score of the upper-limb Fugl-Meyer scale (FMA) (Fugl-Meyer et al., 1975) less than 60. This scale measures the residual motor function of a person after stroke

Exclusion criteria

  • Non-stabilized fractures
  • Diagnosis of depression
  • Traumatic brain Injury
  • Pharmacologically uncontrolled epilepsy
  • Ideomotor apraxia
  • Neglect
  • Mini Mental State Examination (MMSE) score <20/30
  • Severe impairment of verbal comprehension, defined by a score in the Token Test (Tau points<58/78)
  • Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery, etc)

Treatment and study plan

The RehaARM-Robot

Device

Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.

Other names: Robot-assisted therapy for the shoulder

Standard rehabilitation therapy

Behavioral

Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.

Primary outcomes

  1. Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE)

    Time frame: 3 weeks (15 sessions)

    Motor function of the upper limb is measured by means of the Upper Extremity Motor Assessment of the Fugl-Meyer Assessment Scale.

Secondary outcomes

  1. Functional Independence Measure (FIM)

    Time frame: 3 weeks (15 sessions)

    FIM is an 18-item scale that assesses patient's disability and medical rehabilitation functional outcome (A total of 126 points).

  2. Reaching Performance Scale (RPS)

    Time frame: 3 weeks (15 sessions)

    It assesses the ability of subjects to reach an object (a cone). The cone is placed at a 4-cm distance and after at a 30-cm 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 ( A total of 36 points).

  3. Modified Ashworth Scale (MAS) of five muscles

    Time frame: 3 weeks (15 sessions)

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

  4. Nine Hole Pegboard Test (NHPT)

    Time frame: 3 weeks (15 sessions)

    It 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 min are registered or if the patient inserted 9 pins, then the time is registered.

Other outcomes

  1. Shoulder active range of movement (ROM-S)

    Time frame: 3 weeks (15 sessions)

    Active range improvement for shoulder abduction and flexion are measured using the Tyromotion Pablo System.

  2. • Average amount of active task repetitions of a sequence of motor tasks using the robot during a 1-hour therapy treatment.

    Time frame: 3 weeks (15 sessions)

    A higher number of repetitions is a paramount for neuroplasticity. The ability of subjects to execute a larger of number of motor task repetitions with the robot after the treatment is measured.

  3. • Smoothness of the torque (i.e. Number of peaks of the torque, [n]) for a sequence of motor tasks using the robot during a 1-hour therapy treatment .

    Time frame: 3 weeks (15 sessions)

    Smoothness is a measure of human movement coordination. Improvement of smoothness after the treatment is measured.

  4. • Average magnitude of the muscle activation during the active phase normalized by duration of the active phase (magnitude/time) for a sequence of motor tasks using the robot during a 1-hour therapy treatment.

    Time frame: 3 weeks (15 sessions)

  5. • Average similarity between the muscle (synergy) modules of the paretic arm and the muscle modules of the right arm of healthy subjects for a standard sequence of motor tasks using the robot during a 1-hour therapy treatment

    Time frame: 3 weeks (15 sessions)

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Collaborators

  • FerRobotics Compliant Robot GmbH, Linz, Austria

Registry information

Official study title

A Pilot Study of Active, Robot-assisted Therapy for Shoulder Rehabilitation After Stroke, Using Myoelectric Signals

Acronym: MyoReArm

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2014
Registry last updated
Jul 2, 2017

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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