To develop an exergame system which helps patients, ICU staff (including physiotherapists), in ameliorating early mobilisation exercises (frequency, intensity and patient and staff experience), finally aiming to accelerated rehabilitation and reduce…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Patienten die langer dan 24 uur zijn opgenomen op de Intensive Care
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the feasibility of the exergame device to be
developed.
Secondary outcome
Experience of patients and ICU staff with the exergame device to be developed.
Background summary
Healthcare expenditures keep rising. One particularly costly and important
aspect is the Intensive Care Unit (ICU). On the ICU the most fragile and
critical patients are admitted. In ICU patients bed rest and prolonged
immobility commonly occur, increasing the risk of ICU-acquired weakness
(ICU-AW) and other complications. Early mobilization of ICU patients, both
(guided) active exercise therapy and mobilization in a chair, is recommended,
as soon as justified, as it leads to improved muscle strength and functional
independence. It has also been associated with a shorter duration of delirium,
mechanical ventilation, and ICU length of stay. Despite the safety and
feasibility of early mobilisation, most ICU patients remain immobilized for
long periods of time and the number of daily activities is low and limited to
contact moments with the physiotherapist and/or the nursing staff. Intelligent
systems to support data-driven early mobilisation while supporting the ICU
staff are an unmet need. Exergaming, or active video gaming, might be useful in
adding extra exercise moments in supporting early mobilisation. However,
current exergaming devices are not yet suitable for early mobilisation in ICU
patients.
Study objective
To develop an exergame system which helps patients, ICU staff (including
physiotherapists), in ameliorating early mobilisation exercises (frequency,
intensity and patient and staff experience), finally aiming to accelerated
rehabilitation and reduce healthcare costs.
Study design
This is a multicentre feasibility study in which an existing exergaming device
for use in the ICU will be further developed, and evaluated on its feasibility
and validity. Two sites, Erasmus Medical Centre (Erasmus MC) Rotterdam and
Stichting Gelre Hospitals Apeldoorn, are involved in this study.
Study burden and risks
Early mobilisation is shown to be safe and considerated as standard of care.
Early mobilisation exists of kinesiotherapy, transfer and locomotion training,
cycle ergometry as well as neuromuscular electro stimulation. In this process,
the physiotherapist encourages the patient to perform movements and activities.
The exergame device to be developed will be supportive in the early
mobilisation process and will evoke the patient to perform these movements and
activities by means of an interactive video game.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- * 18 years of age
- ICU admission *24 hours
- The ability to sign an informed consent or by a designated family member;
- Being awake, defined as a Richmond Agitation and Sedation Scale (RASS) score
of -1 to 1 (i.e. not sedated or agitated) [41]
- At least Moderate cooperative / some cooperation is possible defined as
Standardized 5 questions; S5Q > 3 [41]
- Absence of delirium, defined as a negative score on the Confusion Assessment
Method for the Intensive Care Unit (CAM-ICU) or *4 on the Intensive Care
Delirium Screening Checklist (ICDSC) [52]
Exclusion criteria
- Haemodynamic instability in which physical exercise is advised against by the
attending physician or attending ICU nurse;
- Impaired sight or hearing that is expected to considerably influence the
ability to play or evaluate the game;
- Language barrier or mentally incapacitated;
- Delirium, defined as a positive score on the CAM-ICU scale (CAM-ICU
positive)>= 3 or >4 on the ICDSC;
- Loss of one or more limbs due to amputations or genetic defects.
Design
Recruitment
Medical products/devices used
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 | NL78997.078.22 |