Clinical Feasibility of ROBERT-SAS in Severely Impaired Stroke Patients

Roessingh Research and Development

Status: Completed

Conditions: Stroke

Treatments: Device: robotic training combined with electrical stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05421910

NL80574.000.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Early training group

Experimental group

Description:

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.

Treatment:

Device: robotic training combined with electrical stimulation

Late training group

Active Comparator group

Description:

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.

Treatment:

Device: robotic training combined with electrical stimulation