Post-Intensive Care SyndromeHANDQUESTNCT06373341
Hand and Arm Rehabilitation Using VR
A study testing VR training for arm and hand rehabilitation in people with Post-Intensive Care Syndrome and ICU Acquired Weakness, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Intensive Care Syndrome, ICU Acquired Weakness
- What is being tested?
- VR training for arm and hand rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jan 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active delirium (CAM-ICU ≥1)
- Severe cognitive dysfunction
- Internal cardiac defibrillator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Dept of intensive care, Medical Centre Leeuwarden
Leeuwarden, Provincie Friesland, 8901 BR
Lise Beumeler, PhD, (058) 286 6738, lise.beumeler@mcl.nl
Lise Beumeler, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- VR training for arm and hand rehabilitation
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR training for arm and hand rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: VR training for arm and hand rehabilitation |
| Standard care | No intervention | The control group will receive standard care rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength
Handgrip strength measured by handheld dynamometer in kg/m2
Measured: 4 weeks after baseline
Secondary outcomes (6)
Handgrip strength
Handgrip strength measured by handheld dynamometer in kg/m2
Measured: 12 weeks after baseline
Arm and hand functionality
Arm and hand functionality measured by Stroke Upper Limb Capacity Scale (SULCS)
Measured: 4 and 12 weeks after baseline
Arm and hand functionality
Arm and hand functionality measured by Medical Research Council (MRC) score
Measured: 4 and 12 weeks after baseline
Arm and hand range of motion
Range of motion of arm and hand by goniometric measurement
Measured: 4 and 12 weeks after baseline
Balance and mobility
Balance and mobility measured by Morton Mobility Index score
Measured: 4 and 12 weeks after baseline
Support need and experience with VR training
Qualitative data obtained from participant observations and interviews on support needs and experience with the VR training
Measured: at baseline, 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start15 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lise Beumeler, Frisius Medisch Centrum
- Investigators
- Lise Beumeler, PhD, Principal investigator, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373341
- Sponsor's protocol ID
- NL85317.099.23
- Acronym
- HANDQUEST
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of HAND and Arm Function Using a Meta QUEST-based Virtual Reality Game in ICU Patients
- ClinicalTrials.gov ID
- NCT06373341
- Acronym / sponsor ID
- HANDQUEST / NL85317.099.23
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR training | Experimental | Behavioral: VR training for arm and hand rehabilitationThe 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. |
| Standard care | No intervention | –The control group will receive standard care rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Active delirium (CAM-ICU ≥1)
- Severe cognitive dysfunction
- Internal cardiac defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR training for arm and hand rehabilitationThe 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. | Behavioural | VR training |
Primary outcome
Handgrip strength
Time frame: 4 weeks after baseline
Handgrip strength measured by handheld dynamometer in kg/m2
6 secondary outcomes
Handgrip strength
Time frame: 12 weeks after baseline
Arm and hand functionality
Time frame: 4 and 12 weeks after baseline
Arm and hand functionality
Time frame: 4 and 12 weeks after baseline
Arm and hand range of motion
Time frame: 4 and 12 weeks after baseline
Balance and mobility
Time frame: 4 and 12 weeks after baseline
Support need and experience with VR training
Time frame: at baseline, 4 weeks and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lise Beumeler, PhD principal investigator
Frisius Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR training for arm and hand rehabilitation in people with Post-Intensive Care Syndrome and ICU Acquired Weakness, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Beumeler, PhD ((058) 286 6738, lise.beumeler@mcl.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip strength (time frame: 4 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.