Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke

Phase 1

Completed

• Conditions: Stroke
• Interventions: Device: The RehaARM-Robot; Behavioral: Standard rehabilitation therapy

• Registration Number: NCT02321254
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-22
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The RehaARM-Robot	Standard rehabilitation therapy	Receive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy.
The RehaARM-Robot	The RehaARM-Robot	Receive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE)	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 Outcome Measures

Name	Time	Method
Functional Independence Measure (FIM)	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).
Reaching Performance Scale (RPS)	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).
Modified Ashworth Scale (MAS) of five muscles	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).
Nine Hole Pegboard Test (NHPT)	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.

Trial Locations

Locations (2)

FerRobotics Compliant Robot Technology GmbH; 🇦🇹 Linz, Austria

IRCCS San Camillo Hospital Foundation; 🇮🇹 Venice, Italy