Clinical trial NCT05421910: Clinical Feasibility of ROBERT-SAS in Severely Impaired Stroke Patients
Official title: Clinical Feasibility of ROBERT-SAS in Severely Impaired Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Robotic
Electrical stimulation
Lower extremity
Stroke
Lead sponsor: Roessingh Research and Development
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: Lifescience-Robotics
First posted: 2022-06-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: One group will receive robotic training as soon as possible, another group will receive robotic training 3-5 weeks, after submission to the rehab center. Normal rehabilitation will also carry on.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: System Usability Scale (SUS) score
timeFrame: 15 minutes
Secondary outcomes:
measure: Electromyography (EMG)
timeFrame: 30 minutes
measure: Force
timeFrame: 30 minutes
measure: Frequency
timeFrame: 30 minutes
measure: Assist-As-Needed (AAN) stages
timeFrame: 30 minutes
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 10 minutes
measure: Motricity Index (MI)
timeFrame: 10 minutes
measure: Functional Ambulation Categories (FAC)
timeFrame: 5 minutes
measure: Type of movement
timeFrame: 30 minutes
measure: Questionnaire Experience
timeFrame: 15 minutes
measure: Pulse width of the electrical stimulation
timeFrame: 30 minutes
measure: Amplitude of the electrical stimulation
timeFrame: 30 Minutes
measure: Amount of repetitions
timeFrame: 30 minutes
measure: Resistance level
timeFrame: 30 minutes
Other outcomes:
measure: Gender
timeFrame: 1 minutes
measure: Age
timeFrame: 1 minutes
measure: Time since stroke
timeFrame: 1 minutes
measure: Weight
timeFrame: 1 minutes
measure: Height
timeFrame: 1 minutes
measure: Affected side
timeFrame: 1 minutes
Locations:
city: Enschede
country: Netherlands
facility: Roessingh Research and Development
state: Overijssel
Study officials:
affiliation: Roessingh Research and Development
name: Gerdienke Prange, PhD
role: PRINCIPAL_INVESTIGATOR
References: