Hand and Arm Rehabilitation Using VR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrisius Medisch Centrum
About this trial
Patients admitted to the ICU due to critical illness often experience physical, mental, cognitive, or social issues. Research indicates that inadequate physical recovery is associated with lower handgrip strength, and hand function in ICU patients is lower compared to healthy individuals. To address this, a Virtual Reality (VR) exergame was developed to aid rehabilitation. This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength, hand and arm functionality, balance, mobility, and support needs in ICU patients staying for 48 hours or longer. It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients. The intervention involves a 4-week VR-exergame program. Main study parameters include handgrip strength, hand and arm functionality, range of motion, balance, mobility, and support needs. The burden and risks associated with participation are minimal, as VR-based exercises are deemed safe and voluntary. Overall, the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Length of stay ICU ≥48 hours
Lives in catchment area of one of the Frisian hospitals
Understands the Dutch language
Intact motor skills of at least one upper extremity
Disqualifiers
Active delirium (CAM-ICU ≥1)
Severe cognitive dysfunction
Internal cardiac defibrillator
Trial design
Design model
Parallel
Treatments tested in this trial
VR training for arm and hand rehabilitation
BehavioralThe intervention group will participate in training with a VR-exergame for 4 weeks after inclusion. For this training a Meta Quest VR-headset with a game specifically designed for and with ICU patients that was previously pilot tested for feasibility and safety will be used under supervision of a researcher or caregiver until the patient feels ready to practice alone.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: VR trainingExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Handgrip strength
Handgrip strength measured by handheld dynamometer in kg/m2
Time frame
4 weeks after baselineSecondary outcomes
1
Handgrip strength
Handgrip strength measured by handheld dynamometer in kg/m2
Time frame
12 weeks after baseline2
Arm and hand functionality
Arm and hand functionality measured by Stroke Upper Limb Capacity Scale (SULCS)
Time frame
4 and 12 weeks after baseline3
Arm and hand functionality
Arm and hand functionality measured by Medical Research Council (MRC) score
Time frame
4 and 12 weeks after baseline4
Arm and hand range of motion
Range of motion of arm and hand by goniometric measurement
Time frame
4 and 12 weeks after baselineSponsors and contacts
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Source ClinicalTrials.gov