Stroke Clinical Trial
— RETRAINER-S2Official title:
Reaching Training Based on Robotic Hybrid Assistance for Stroke Patients
Stroke is the third most common cause of death and the main cause of acquired adult
disability in high-income countries. The most common deficit after stroke is motor impairment
of the contralateral arm, with more than 80% of stroke survivors experiencing this condition
in the acute phase, and only half regaining some useful upper limb function after six months.
Within the European project RETRAINER (grant agreement No 644721), the consortium developed a
platform for the rehabilitation of the upper limb after stroke, which combines a passive
forearm-hand orthosis for hand-wrist motion stabilization, selective fingers constraining and
grasp movement facilitation, Functional Electrical Stimulation (FES) of the extrinsic hand
flexor muscles and of the extrinsic hand extensor muscles, interactive objects, and voluntary
effort. The system also provides a graphical user interface which helps the therapist set the
training session and save the training data and parameters, and provides the subject a visual
feedback about his/her active involvement in the exercise. The training consists of the
execution of a series of exercises involving the affected arm during daily life activities.
Typical exercises include controlled wrist flexion and extension, controlled fingers flexion
and extension, anterior reaching and grasping on a plane or in the space, moving an object on
a plane or in the space.
The aim of this clinical study it to evaluate the efficacy of this novel training platform on
patients between two weeks and nine months after their first stroke, who preserved at least a
visible muscle contraction for the arm and shoulder muscles. Participants are randomized in
an experimental and a control group. The control group is trained with an advanced
rehabilitative program, including physical training, occupational therapy, FES, and virtual
reality, while the experimental group is trained with the RETRAINER system for about 30
minutes, in addition to the same program of the control group. The daily training time is the
same for the two groups. The intervention consists of three sessions a week for nine weeks.
Patients are assessed at baseline, soon after the end of the intervention, and in a 4-week
follow-up visits. It is planned to recruit 68 subjects for this study. Since the RETRAINER
platform was built on the up-to-date theory of motor re-learning, which supports
task-oriented repetitive training, a close temporal association between motor intention and
stimulated motor response, and an intensive and frequent training paradigm, the study's
hypothesis is that the experimental group shows a greater treatment effect than the control
group.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | May 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Adults male and/or female, 18-85 years old - Patients who have suffered a first stroke with major unilateral functional impairment - Acute event between two weeks and nine months before study enrollment - Motricity Index of the affected side must be under 80% of best expected performance. - No major contralateral impairment must be present (Motricity Index of the non-affected side more than 80% of normality) - Residual muscular activity for forearm muscles (MRC > o = 1) - Mini-Mental State Examination > 20 Exclusion Criteria: - Limitation for using the device due to impairment of Passive Range of Motion and/or - Pain due to Spasticity evaluated using Modified Ashworth Scale - Previous history of major neurological or psychiatric disorders - allergy to electrodes |
Country | Name | City | State |
---|---|---|---|
Germany | Asklepios Neurologische Klinik Falkenstein | Konigstein im Taunus | |
Italy | Villa Beretta Rehabilitation Center | Costa Masnaga | Lecco |
Lead Sponsor | Collaborator |
---|---|
Dr. Franco Molteni | Ab.Acus, Milan, Italy, Asklepios Neurologische Klinik Falkenstein, Königstein, Germany, Control Systems Group, Technische Universität Berlin, Germany, Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy, Ecole Polytechnique Fédérale de Lausanne, Hasomed GmbH, Magdeburg, Germany, Ottobock Health Products GmbH, Wien, Austria, Technische Universität Wien, Austria |
Germany, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Action Research Arm Test | 9-item outcome measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test |
9 weeks | |
Secondary | Action Research Arm Test | 9-item outcome measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test |
13 weeks | |
Secondary | Medical Research Council | A standardized assessment to measure muscle strength; Score range 0-5 (minimum 0, maximum 5) | baseline; 9 weeks; 13 weeks | |
Secondary | Motricity index | Outcome measure to evaluate motor impairment after stroke; 2 sub-scales (arm and leg); each subscale ranges from 0 (maximal impairment) to 100 (no impairment) | baseline; 9 weeks; 13 weeks | |
Secondary | Motor Activity Log | Semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement and Amount of Movement during 30 daily functional tasks. Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting). Items scored on a 6-point ordinal scale (0 not used, 6 as good as before). |
baseline; 9 weeks; 13 weeks | |
Secondary | Box & Blocks Test | It assesses unilateral gross manual dexterity. Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. To administer the test, the examiner is seated opposite the individual in order to observe test performance. The test is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. |
baseline; 9 weeks; 13 weeks | |
Secondary | Stroke Specific Quality Of Life scale | It assesses the health-related quality of life specific to stroke survivors. It consists of 49 items, each assessed on 5-point Guttman-type scales. Score range: 49-245 with higher score indicating better functioning. It covers 12 domains which are: Mobility Energy Upper Extremity Function Work and Productivity Mood Self-care Social Roles Family Roles Vision Language Thinking Personality |
baseline; 9 weeks; 13 weeks | |
Secondary | Modified Ashworth Scale | It measures spasticity. It consists of a test resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-5; a score of 0 indicates no resistance, 5 indicates rigidity. target muscles: Wrist flexor and extensor, fingers and thumb flexor and extensor |
baseline; 9 weeks; 13 weeks | |
Secondary | Instrumental assessment | Dynamic electromyography (EMG) signals of the Wrist flexor and extensor, fingers and thumb flexor and extensor as well as kinematic data are measured during free-movement of the wrist and the hand | baseline; 9 weeks; 13 weeks | |
Secondary | System Usability Scale | A 10-item questionnaire to measure system usability. Each item has five response options, from "Strongly agree" to "Strongly disagree". | 9 weeks | |
Secondary | Technology Acceptance Model | A standardized questionnaire that measures technology acceptance. The questionnaire consists of 2 parts, 10 items to measure usefulness and 10 items to measure ease of use. Participants are asked to provide their level of agreement on a 7-point scale (1=strongly disagree and 7 = strongly agree). |
9 weeks |
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