Hand and Arm Rehabilitation Using VR

NCT06373341 | Recruiting

• 1 other identifier: NL85317.099.23
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Intensive Care Syndrome; ICU Acquired Weakness

Outcome Measures

Primary Outcomes (1)

• Handgrip strength

  Handgrip strength measured by handheld dynamometer in kg/m2

  4 weeks after baseline

Secondary Outcomes (6)

• Handgrip strength

  12 weeks after baseline

• Arm and hand functionality

  4 and 12 weeks after baseline

• Arm and hand functionality

  4 and 12 weeks after baseline

• Arm and hand range of motion

  4 and 12 weeks after baseline

• Balance and mobility

  4 and 12 weeks after baseline

Study Arms (2)

VR training

EXPERIMENTAL

The 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.

Behavioral: VR training for arm and hand rehabilitation

Standard care

NO INTERVENTION

The control group will receive standard care rehabilitation.

Interventions

VR training for arm and hand rehabilitation BEHAVIORAL

The 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.

VR training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active delirium (CAM-ICU ≥1)
• Severe cognitive dysfunction
• Internal cardiac defibrillator

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Dept of intensive care, Medical Centre Leeuwarden

Leeuwarden, Provincie Friesland, 8901 BR, Netherlands

RECRUITING

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• Lise Beumeler, PhD

  Frisius Medisch Centrum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Beumeler, PhD

CONTACT

(058) 286 6738; lise.beumeler@mcl.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 18, 2024
• Study Start: January 15, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)