Clinical Feasibility of ROBERT-SAS in Severely Impaired Stroke Patients

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: robotic training combined with electrical stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7522AH
      • Roessingh Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sub(acute) stroke (< 6 months post-stroke)
• Above 18 years
• Able to provide informed consent
• An ischemic or haemorrhagic stroke
• Hemiparetic lower extremity

Exclusion Criteria:

• Premorbid disability of lower extremity
• Severe cognitive impairment, unable to follow simple instructions and unable to understand Dutch.
• Skin lesions at the hemiparetic leg
• Progressive neurological diseases (i.e. Parkinson, dementia, etc.)
• Contraindication for mobilization like unhealed lower limb fracture
• Use of pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early training group; 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; Active training of movements in supine position. Movements such as knee extension and ankle dorsal flexion.
Active Comparator: Late training group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography (EMG)	Surface EMG of the muscle that will be stimulated with electrical stimulation, expressed in volt.	30 minutes
Force	Resulting force measured with the robot, expressed in kg	30 minutes
Frequency	As a settings of the stimulation expressed in Hertz	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.	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.	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)	10 minutes
Functional Ambulation Categories (FAC)	To assess the walking capabilities, score between 0 and 5, in which 5 indicates a better walking capability.	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.	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.	15 minutes
Pulse width of the electrical stimulation	As a settings of the stimulation expressed in milliseconds	30 minutes
Amplitude of the electrical stimulation	As a settings of the stimulation expressed in milliampere	30 Minutes
Amount of repetitions	The amount of repetitions during one set of a specific movement.	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.	30 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	gender will be noted as subject characteristic	1 minutes
Age	Age will be noted as subject characteristic in years	1 minutes
Time since stroke	time science stroke will be noted as subject characteristic in months	1 minutes
Weight	Weight will be noted as subject characteristic and used for BMI calculation, noted in kg	1 minutes
Height	Height will be noted as subject characteristic and used for BMI calculation, noted in meters	1 minutes
Affected side	The affected side will be used as subject characteristic	1 minutes

Collaborators and Investigators

• Sponsor: Roessingh Research and Development
• Collaborators: Aalborg University; Lifescience-Robotics
• Investigators: Principal Investigator: Gerdienke Prange, PhD, Roessingh Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): August 24, 2023
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Robotic; Electrical stimulation; Lower extremity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NL80574.000.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No