Clinical Feasibility of ROBERT-SAS in Severely Impaired Stroke Patients

Stroke Clinical Trial

Official title:

Clinical Feasibility of ROBERT-SAS in Severely Impaired Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421910
• Other study ID #: NL80574.000.22
• Status: Completed
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: August 24, 2023

Study information

• Verified date: September 2023
• Source: Roessingh Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 24, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• robotic training combined with electrical stimulation
Active training of movements in supine position. Movements such as knee extension and ankle dorsal flexion.

Locations

Country	Name	City	State
Netherlands	Roessingh Research and Development	Enschede	Overijssel

Sponsors (3)

Lead Sponsor	Collaborator
Roessingh Research and Development	Aalborg University, Lifescience-Robotics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender	gender will be noted as subject characteristic	1 minutes
Other	Age	Age will be noted as subject characteristic in years	1 minutes
Other	Time since stroke	time science stroke will be noted as subject characteristic in months	1 minutes
Other	Weight	Weight will be noted as subject characteristic and used for BMI calculation, noted in kg	1 minutes
Other	Height	Height will be noted as subject characteristic and used for BMI calculation, noted in meters	1 minutes
Other	Affected side	The affected side will be used as subject characteristic	1 minutes
Primary	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	Electromyography (EMG)	Surface EMG of the muscle that will be stimulated with electrical stimulation, expressed in volt.	30 minutes
Secondary	Force	Resulting force measured with the robot, expressed in kg	30 minutes
Secondary	Frequency	As a settings of the stimulation expressed in Hertz	30 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional Ambulation Categories (FAC)	To assess the walking capabilities, score between 0 and 5, in which 5 indicates a better walking capability.	5 minutes
Secondary	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
Secondary	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
Secondary	Pulse width of the electrical stimulation	As a settings of the stimulation expressed in milliseconds	30 minutes
Secondary	Amplitude of the electrical stimulation	As a settings of the stimulation expressed in milliampere	30 Minutes
Secondary	Amount of repetitions	The amount of repetitions during one set of a specific movement.	30 minutes
Secondary	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