Exploring and evaluating solutions for providing wrist assistance using functional electrical stimulation and an active wrist robot within the ReHyb system

Not Applicable

Recruiting

• Conditions: Paresis in upper-limb due to ischemic or hemorrhagic stroke; I61; I63; I64; Intracerebral haemorrhage; Cerebral infarction; Stroke, not specified as haemorrhage or infarction

• Registration Number: DRKS00030586
• Lead Sponsor: Schön Klinik Bad Aibling

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Subacute and chronic patient after stroke in an inpatient rehabilitation centre,
Ischemic or hemorrhagic infarction,
Age >= 18 years,
Cognitively able to follow instructions,
Low level or no pain in wrist or fingers at rest (NRS < 4),
Functional impairments in wrist or fingers (MRC <=3),
Able to sit in a chair with the wrist position in the robotic device for the duration of the session (session < 2 hours),
Familiar with electrical stimulation,
Able to understand and accept their participation in one of the studies.

Exclusion Criteria

robot-related exclusion criteria:
High level of pain in the wrist or hand resulting in the operator’s inability to position the user’s arm and hand in the HRX-1 device and flex or extend the user’s wrist more than 20 degrees while in the robot
Severe contractures or muscle tone resulting in the operator’s inability to position the user’s arm and hand in the HRX-1 device and flex or extend or rotate the user’s wrist more than 20 degrees while in the robot
Severe psychiatric disorder

FES-related exclusion criteria:
Pregnancy
People with active implantable devices (e.g., pacemakers) or other metal implants within the area stimulated by the FES device
No motion or muscle contraction resulting from FES (atrophy)
Patients suffering from peripheral nerve damage (e.g., polyneuropathy)
Patients with severe epilepsy or frequent epileptic seizures in the past
Cancer or wounds in the FES application area
Other exclusion criteria:
Patient has no function AND no deep sensitivity in the fingers or wrist

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kinematics (i.e., wrist motion): measured from sensors in robotic device.<br>Outcome will be measured during all training sessions. <br><br>Kinetics (i.e., torque): measured from sensors in robotic device.<br>Outcome will be measured during all training sessions. <br><br>Neurophysiological signals (i.e., EMG and/or EEG): measured from sensors placed on the skin. EMG signals will be obtained during all training sessions and EEG signals will be obtained for some participants during all training sessions. <br><br>Subjective outcomes about interaction experience: measured from patient-reported questionnaires. Outcomes will be obtained during and after all training sessions. <br>

Secondary Outcome Measures

Name	Time	Method
Serious gaming scores of the tracking task: calculated by the software by using metrics such as the distance between the target position and the subject's position. Outcome will be obtained during all training sessions.<br>