Hand and Arm Rehabilitation Using VR (HANDQUEST)

April 15, 2024 updated by: Lise Beumeler, Medical Centre Leeuwarden

Rehabilitation of HAND and Arm Function Using a Meta QUEST-based Virtual Reality Game in ICU Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale: Patients admitted to the Intensive Care Unit (ICU) due to critical illness may experience new or increased physical, mental, cognitive or social problems. Research from the MCL showed that patients with inadequate physical recovery after one year also have lower handgrip strength at discharge from the ICU and after three months. In addition, a recent study indicated that hand function after ICU admission is lower than in a healthy control group. Early mobilisation focussing on regain of function is therefore essential in ICU patients. Previously, the MCL and 8D Games developed a Virtual Reality exergame that is safe and feasible to use as an addition to standard care mobilisation in the ICU ward. Although the primary goal of the VR-exergame is to provide personalised and fun options in rehabilitation, it may also have additional benefits when it comes to recovery after critical illness. In addition, the VR-exergame may be a feasible option for performing rehabilitation exercises after hospital discharge.

Objective:

Primary:

To investigate the effect of a 4-week VR-exergame intervention on handgrip strength in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices.

Secondary:

To investigate the longer term effect of a 4-week VR-exergame intervention on handgrip strength in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices at 12 weeks after baseline.

To investigate the effect of a 4-week VR-exergame intervention on hand and arm functionality in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices.

To investigate the effect of a 4-week VR-exergame intervention on balance and mobility in patients staying in the ICU for 48 hours or longer compared to standard rehabilitation practices.

To identify support needs of patients staying in the ICU for 48 hours or longer related to the use of a VR-exergame in hospital and in the home situation.

Study design: Multicentre mixed-methods randomised controlled trial.

Study population: Adult ICU patients with a length of stay in ICU of at least 48 hours.

Intervention: 4-week VR-exergame intervention.

Main study parameters/endpoints: Handgrip strength measured by handheld dynamometer, hand and arm functionality by Stroke Upper Limb Capacity Scale and MRC score, hand and wrist range of motion, balance and mobility by Morton Mobility Index and support needs by observational field notes combined with a semi-structured interview.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: VR-based exercises have been used previously in various patient groups, including ICU-patients, and are a safe addition to standard healthcare. Participation with this training is voluntary and an addition to the standard care physical rehabilitation protocol. Patients can stop the exercise at any moment in time, without having to provide an explanation. The exercise activity will be guided and supervised by a trained researcher. Participation in the study measurements and semi-structured interview will require mental effort, but can be conducted in the patients' current living situation to limit burden. Overall, the expected extent of the burden and risks associated with using this healthcare innovation are limited.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Friesland
      • Leeuwarden, Friesland, Netherlands, 8901 BR
        • Recruiting
        • Dept of intensive care, Medical Centre Leeuwarden
        • Contact:
        • Principal Investigator:
          • Lise Beumeler, PhD
        • Principal Investigator:
          • Carina Bethlehem, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VR training
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
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.
No Intervention: Standard care
The control group will receive standard care rehabilitation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: 4 weeks after baseline
Handgrip strength measured by handheld dynamometer in kg/m2
4 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: 12 weeks after baseline
Handgrip strength measured by handheld dynamometer in kg/m2
12 weeks after baseline
Arm and hand functionality
Time Frame: 4 and 12 weeks after baseline
Arm and hand functionality measured by Stroke Upper Limb Capacity Scale (SULCS)
4 and 12 weeks after baseline
Arm and hand functionality
Time Frame: 4 and 12 weeks after baseline
Arm and hand functionality measured by Medical Research Council (MRC) score
4 and 12 weeks after baseline
Arm and hand range of motion
Time Frame: 4 and 12 weeks after baseline
Range of motion of arm and hand by goniometric measurement
4 and 12 weeks after baseline
Balance and mobility
Time Frame: 4 and 12 weeks after baseline
Balance and mobility measured by Morton Mobility Index score
4 and 12 weeks after baseline
Support need and experience with VR training
Time Frame: at baseline, 4 weeks and 12 weeks
Qualitative data obtained from participant observations and interviews on support needs and experience with the VR training
at baseline, 4 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical Centre Leeuwarden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lise Beumeler, PhD, Medical Centre Leeuwarden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL85317.099.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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