An interventional study of robotic training combined with electrical stimulation in Stroke, sponsored by Roessingh Research and Development. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Roessingh Research and Development · Not applicable, Interventional, and Device feasibility
Robotic training can be used to provide intensive training during the (early phases of) rehabilitation of a stroke. ROBERT®-SAS training is designed to create an active and intensive training tool for the rehabilitation of the lower extremity of stroke patients. Currently this has only be tested in a lab-based setting, which showed that is was feasible and could be executed while still being comfortable for the patient. The next step will be implementing the device in a clinical setting. Therefore, aims the current study to assess the feasibility of ROBERT®-SAS training in clinical setting, in acute stroke patients.
Rationale: Stroke is one of the leading causes of disability of adults in the European Union. Around 80% of stroke survivors experience deficits in motor control, resulting in problems with keeping balance and walking, for instance. The extent and amount of deficits differ per individual. Interventions to train the lower extremity almost always consist of walking exercises. However, patients in the acute phase or with severely affected lower extremity function are often unable to walk or to walk independently. Therefore, the combination of a robot (ROBERT®) and functional electrical stimulation (ES) is being developed to provide a training tool for early rehabilitation. In the current study a combination of robot and ES will be evaluated in clinical setting.
Objective: The primary objective of the current study is to assess the feasibility of ROBERT®-SAS training in clinical setting, in acute stroke patients, including patient and therapist perspectives.
Study design: The current study is an observational study.
Study population: In the current study ten (sub) acute stroke patient will be included, with severely affected lower extremity. Five of these ten will be included as soon as possible after arrival at the rehabilitation centre. Another five will be included 3-5 weeks after arrival/start of the rehabilitation.
Main study parameters/endpoints: The main outcome parameter is the SUS score from both the patients and the therapists.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The current study consists of several measurement sessions in Roessingh Rehabilitation Centre, during the normal rehabilitation time. The robot, ROBERT® is CE-certified. However, the combination ROBERT®-SAS, combining both ES and robot support, is not, although previous tests have shown this approach is possible and tolerable by healthy persons and stroke patients. The risks are regarded as minimal because it is without invasive procedures, with room for rest in between trial sets as required by the participant, and application of individual stimulation profiles to not exceed tolerance levels or inflict pain during electrostimulation.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Roessingh Research and Development is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
The early group will receive robotic training combined with electrical stimulation as soon as possible after submission to the rehab center. With a frequency of three times a week for 3-5 weeks, dependent on the capabilities of the patients.
Device: robotic training combined with electrical stimulation
The late training group will receive robotic training combined with electrical stimulation 3-5 weeks after submission to the rehab center. With a frequency of three times a week for 3-5 weeks, dependent on the capabilities of the patients.
Device: robotic training combined with electrical stimulation
Active training of movements in supine position. Movements such as knee extension and ankle dorsal flexion.
System Usability Scale (SUS) score
The System Usability Scale of patients and therapists. 10 questions with a 5-point response scale. The total score can range from 0 - 100, in which a higher score indicates a better usability
Time frame: 15 minutes
Electromyography (EMG)
Surface EMG of the muscle that will be stimulated with electrical stimulation, expressed in volt.
Time frame: 30 minutes
Force
Resulting force measured with the robot, expressed in kg
Time frame: 30 minutes
Frequency
As a settings of the stimulation expressed in Hertz
Time frame: 30 minutes
Assist-As-Needed (AAN) stages
The trajectory completion rate for the different stages of AAN. (different types of assistance). There are three different types, no assistance, electrical stimulation assistance and an combination of electrical stimulation and robot support.
Time frame: 30 minutes
Fugl-Meyer Assessment (FMA)
Lower extremity module, to assess leg function. Scores can range between 0 and 28, in which a higher score indicates a higher leg function.
Time frame: 10 minutes
Motricity Index (MI)
Lower extremity part, to assess the leg function. Scored for Ankle, knee and hip separately between 0 - 33 in which zero is know movement and 33 is normal movement. Total score can range between 0 - 99. (summation of the three joints)
Time frame: 10 minutes
Functional Ambulation Categories (FAC)
To assess the walking capabilities, score between 0 and 5, in which 5 indicates a better walking capability.
Time frame: 5 minutes
Type of movement
Type of movement that will be trained during the measurements. Can be knee extension or ankle dorsal flexion with electrical stimulation.
Time frame: 30 minutes
Questionnaire Experience
Questions about their experience with ROBERT for all stakeholders. Open questions which will not have a score, but will be interpreted on question level.
Time frame: 15 minutes
Pulse width of the electrical stimulation
As a settings of the stimulation expressed in milliseconds
Time frame: 30 minutes
Amplitude of the electrical stimulation
As a settings of the stimulation expressed in milliampere
Time frame: 30 Minutes
Amount of repetitions
The amount of repetitions during one set of a specific movement.
Time frame: 30 minutes
Resistance level
The amount of resistance during the training, can be changed during a set if necessary. The resistance can differ between 0-10, in which 10 is the heaviest.
Time frame: 30 minutes
Gender
gender will be noted as subject characteristic
Time frame: 1 minutes
Age
Age will be noted as subject characteristic in years
Time frame: 1 minutes
Time since stroke
time science stroke will be noted as subject characteristic in months
Time frame: 1 minutes
Weight
Weight will be noted as subject characteristic and used for BMI calculation, noted in kg
Time frame: 1 minutes
Height
Height will be noted as subject characteristic and used for BMI calculation, noted in meters
Time frame: 1 minutes
Affected side
The affected side will be used as subject characteristic
Time frame: 1 minutes
Plan to share: No
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Roessingh Research and Development