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-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Post-Intensive Care Syndrome
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in handgrip strength by handheld dynamometer at 4 weeks
Secondary outcome
Difference in handgrip strength by handheld dynamometer at 12 weeks
Difference in upper limb function by Stroke Upper Limb Capacity Scale, MRC
score and range of motion at 4 and 12 weeks
Difference in balance and mobility using the Morton Mobility Index at 4 and 12
weeks
Observational and interview data on support needs
Background summary
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.
Study 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.
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.
Intervention
4-week VR-exergame intervention.
Study burden and risks
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.
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
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 defibrilator
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL85317.099.23 |