ICU-acquired WeaknessNCT07896057
Evidence-based, Customized, Motion-recognition Rehabilitation System Development for Bed-ridden Patients - Validation of Effectiveness: Rehabit: Swim
A study testing Rehabilitation in people with ICU-acquired Weakness, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This pilot study aims to evaluate the efficacy, safety, feasibility, and user satisfaction of "Rehabit: swim," a customized, evidence-based, motion-recognition-based rehabilitation exergame designed for hospitalized patients with limited mobility, particularly those with a history of intensive care unit (ICU)… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- ICU-acquired Weakness
- What is being tested?
- Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2026to 30 Sep 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older
- Patients who have a history of intensive care unit (ICU) admission during their hospital stay
Who cannot join
- Patients who have difficulty cooperating with the rehabilitation exercise program due to inappropriate conscious level or cognitive level
- Patients with persistent biomechanical instability
- Patients requiring movement restrictions due to fractures or skeletal instability that limit the necessary movements for the rehabilitation exercise program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This pilot study aims to evaluate the efficacy, safety, feasibility, and user satisfaction of "Rehabit: swim," a customized, evidence-based, motion-recognition-based rehabilitation exergame designed for hospitalized patients with limited mobility, particularly those with a history of intensive care unit (ICU) admission. A total of 20 participants will perform the rehabilitation exergaming program while lying or sitting in bed. The intervention consists of 30-minute sessions, once a day, for a total of 10 sessions over approximately 2 weeks. Clinical outcomes, physical performance measures, and user experience metrics will be assessed before and after the intervention.
Read the detailed description
Background \& Rationale: Hospitalized patients, especially those recovering from critical illnesses or experiencing ICU-acquired weakness (ICU-AW) and sarcopenia, often face severe mobility restrictions. While early rehabilitation is crucial for functional recovery and reducing complications, available exercise options for bedridden patients are frequently monotonous, limiting patient motivation and adherence. To overcome these limitations, "Rehabit: swim," a customized interactive exergame optimized for bedridden patients, was developed.
Study Objectives: The primary objective is to investigate the efficacy, safety, and feasibility of utilizing the Rehabit: swim exergaming program in improving physical function, muscle strength, mobility, and quality of life among hospitalized patients with a history of ICU stays.
Study Design \& Methods:
Design: A prospective, single-center pilot study. Participants: 20 adult inpatients (≥19 years old) who meet the inclusion and exclusion criteria, including a history of ICU admission during their hospital stay.
Intervention: Participants will perform tailored rehabilitation exercise games using Rehabit: swim while in a bed (lying or sitting posture). The intervention is planned for 30 minutes per session, once daily, 10 sessions total within a 2-week period (extendable up to 3 weeks depending on condition).
Outcomes and Data Collection:
Clinical \& Functional Assessments: Evaluated at pre- and post-intervention, including Medical Research Council Sum Score (MRC-SS), grip strength, Functional Ambulatory Category (FAC), ICU Mobility Scale (ICU-MS), EQ-5D, EQ-VAS, K-MMSE2, Intrinsic Motivation Inventory (IMI), and Game User Experience Satisfaction Scale-18 (GUESS-18).
Intervention Metrics: Physical motion data (range of motion, angles, speed) captured via Inertial Measurement Units (IMUs), built-in metrics (calories burned, game scores, exercise time), heart rate changes, adherence, session completion/cessation reasons, and adverse events (e.g., falls).
- Conditions
- ICU-acquired Weakness
- Being tested
- Rehabilitation
- Keywords
- Exergaming, Virtual Reality Rehabilitation, Motion Recognition, Bedridden Patients, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationDevice
Hospitalized patients with limited mobility, including those with a history of intensive care unit (ICU) admission, will perform customized rehabilitation exercise games using the "Rehabit: swim" motion-recognition system in a bed setting. The intervention is administered for 30 minutes per session, once daily, totaling 10 sessions over approximately 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | All participants will receive the Rehabit: swim rehabilitation exergaming intervention for approximately 2 weeks (total of 10 sessions, 30 minutes per session) while in a bed (lying or sitting posture). Receives: Device: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session Adherence Rate
Percentage of the 10 planned Rehabit: swim sessions attended by each participant, calculated as (number of sessions attended ÷ 10) × 100. A session is counted as attended when the participant starts the scheduled exercise-game session.
Measured: From the first intervention session (Game 1) through the tenth session (Game 10), up to 3 weeks
Intervention Completion Rate
Percentage of enrolled participants who complete all 10 Rehabit: swim sessions within 3 weeks of the first session.
Measured: From the first intervention session (Game 1) through the tenth session (Game 10), up to 3 weeks
Secondary outcomes (8)
Medical Research Council Sum Score (MRC-SS)
Change in muscle strength assessed using the MRC-SS. Scores range from 0 to 60; higher scores indicate greater muscle strength (better outcome).
Measured: Baseline and post-intervention (approx. 2 weeks).
Grip Strength
Change in handgrip strength.
Measured: Baseline and post-intervention (approx. 2 weeks).
Functional Ambulatory Category (FAC)
Changes in functional mobility and ambulation status measured by the Functional Ambulation Category (FAC). Scores range from 0 (nonfunctional ambulator) to 5 (independent ambulator on any surface, including stairs); higher scores indicate greater walking independence (better outcome).
Measured: Baseline and post-intervention (approx. 2 weeks).
ICU Mobility Scale (ICU-MS)
Changes in functional mobility and ambulation status measured by the Intensive Care Unit Mobility Scale (ICU-MS). Scores range from 0 (lying in bed, no active movement) to 10 (walking independently without a gait aid); higher scores indicate greater mobility (better outcome).
Measured: Baseline and post-intervention (approx. 2 weeks).
EQ-5D-5L Index
Health-related quality of life measured with the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), which assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on 5 levels from no problems to extreme problems. Responses are converted to a single index value using the Korean EQ-5D-5L value set (range -0.066 to 1; higher values indicate better health). Change is calculated as the post-intervention value minus the baseline value; positive values indicate improvement.
Measured: Baseline and post-intervention (approx. 2 weeks).
EQ-VAS
Self-rated overall health measured with the EQ-VAS, ranging from 0 (worst imaginable health) to 100 (best imaginable health); higher scores indicate better self-rated health. Change is calculated as the post-intervention score minus the baseline score; positive values indicate improvement.
Measured: Baseline and post-intervention (approx. 2 weeks).
Intrinsic Motivation Inventory (IMI) Interest/Enjoyment Subscale Score
Intrinsic motivation toward the Rehabit: swim exercise game measured with the Interest/Enjoyment subscale of the IMI, consisting of 7 items rated from 1 ("not at all true") to 7 ("very true"), with 2 items reverse-scored. The subscale score is the mean of the 7 items (range 1 to 7); higher scores indicate greater intrinsic motivation.
Measured: Baseline and post-intervention (approx. 2 weeks).
Game User Experience Satisfaction Scale-18 (GUESS-18) Composite Score
Satisfaction with the Rehabit: swim exercise game measured with the GUESS-18, consisting of 18 items across 9 subscales rated from 1 ("strongly disagree") to 7 ("strongly agree"), with 1 item reverse-scored. Items are averaged within each subscale, and the 9 subscale scores are summed to obtain the composite score (range 9 to 63); higher scores indicate greater game satisfaction.
Measured: Baseline and post-intervention (approx. 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU-acquired WeaknessStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896057
- Sponsor's protocol ID
- S2026-2528-0001
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based, Customized, Motion-recognition Rehabilitation System Development for Bed-ridden Patients - Validation of Effectiveness: Rehabit: Swim
- ClinicalTrials.gov ID
- NCT07896057
- Acronym / sponsor ID
- S2026-2528-0001
- Conditions
- ICU-acquired Weakness
- Keywords
- Exergaming, Virtual Reality Rehabilitation, Motion Recognition, Bedridden Patients, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
This pilot study aims to evaluate the efficacy, safety, feasibility, and user satisfaction of "Rehabit: swim," a customized, evidence-based, motion-recognition-based rehabilitation exergame designed for hospitalized patients with limited mobility, particularly those with a history of intensive care unit (ICU) admission. A total of 20 participants will perform the rehabilitation exergaming program while lying or sitting in bed. The intervention consists of 30-minute sessions, once a day, for a total of 10 sessions over approximately 2 weeks. Clinical outcomes, physical performance measures, and user experience metrics will be assessed before and after the intervention.
Detailed description
Background \& Rationale: Hospitalized patients, especially those recovering from critical illnesses or experiencing ICU-acquired weakness (ICU-AW) and sarcopenia, often face severe mobility restrictions. While early rehabilitation is crucial for functional recovery and reducing complications, available exercise options for bedridden patients are frequently monotonous, limiting patient motivation and adherence. To overcome these limitations, "Rehabit: swim," a customized interactive exergame optimized for bedridden patients, was developed.
Study Objectives: The primary objective is to investigate the efficacy, safety, and feasibility of utilizing the Rehabit: swim exergaming program in improving physical function, muscle strength, mobility, and quality of life among hospitalized patients with a history of ICU stays.
Study Design \& Methods:
Design: A prospective, single-center pilot study. Participants: 20 adult inpatients (≥19 years old) who meet the inclusion and exclusion criteria, including a history of ICU admission during their hospital stay.
Intervention: Participants will perform tailored rehabilitation exercise games using Rehabit: swim while in a bed (lying or sitting posture). The intervention is planned for 30 minutes per session, once daily, 10 sessions total within a 2-week period (extendable up to 3 weeks depending on condition).
Outcomes and Data Collection:
Clinical \& Functional Assessments: Evaluated at pre- and post-intervention, including Medical Research Council Sum Score (MRC-SS), grip strength, Functional Ambulatory Category (FAC), ICU Mobility Scale (ICU-MS), EQ-5D, EQ-VAS, K-MMSE2, Intrinsic Motivation Inventory (IMI), and Game User Experience Satisfaction Scale-18 (GUESS-18).
Intervention Metrics: Physical motion data (range of motion, angles, speed) captured via Inertial Measurement Units (IMUs), built-in metrics (calories burned, game scores, exercise time), heart rate changes, adherence, session completion/cessation reasons, and adverse events (e.g., falls).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: RehabilitationAll participants will receive the Rehabit: swim rehabilitation exergaming intervention for approximately 2 weeks (total of 10 sessions, 30 minutes per session) while in a bed (lying or sitting posture). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 19 years or older
- Patients who have a history of intensive care unit (ICU) admission during their hospital stay
Key exclusion criteria (3 listed)
- Patients who have difficulty cooperating with the rehabilitation exercise program due to inappropriate conscious level or cognitive level
- Patients with persistent biomechanical instability
- Patients requiring movement restrictions due to fractures or skeletal instability that limit the necessary movements for the rehabilitation exercise program
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 |
|---|---|---|
| RehabilitationHospitalized patients with limited mobility, including those with a history of intensive care unit (ICU) admission, will perform customized rehabilitation exercise games using the "Rehabit: swim" motion-recognition system in a bed setting. The intervention is administered for 30 minutes per session, once daily, totaling 10 sessions over approximately 2 weeks. | Device | Interventional |
Primary outcome
Session Adherence Rate
Time frame: From the first intervention session (Game 1) through the tenth session (Game 10), up to 3 weeks
Percentage of the 10 planned Rehabit: swim sessions attended by each participant, calculated as (number of sessions attended ÷ 10) × 100. A session is counted as attended when the participant starts the scheduled exercise-game session.
Intervention Completion Rate
Time frame: From the first intervention session (Game 1) through the tenth session (Game 10), up to 3 weeks
Percentage of enrolled participants who complete all 10 Rehabit: swim sessions within 3 weeks of the first session.
8 secondary outcomes
Medical Research Council Sum Score (MRC-SS)
Time frame: Baseline and post-intervention (approx. 2 weeks).
Grip Strength
Time frame: Baseline and post-intervention (approx. 2 weeks).
Functional Ambulatory Category (FAC)
Time frame: Baseline and post-intervention (approx. 2 weeks).
ICU Mobility Scale (ICU-MS)
Time frame: Baseline and post-intervention (approx. 2 weeks).
EQ-5D-5L Index
Time frame: Baseline and post-intervention (approx. 2 weeks).
EQ-VAS
Time frame: Baseline and post-intervention (approx. 2 weeks).
Intrinsic Motivation Inventory (IMI) Interest/Enjoyment Subscale Score
Time frame: Baseline and post-intervention (approx. 2 weeks).
Game User Experience Satisfaction Scale-18 (GUESS-18) Composite Score
Time frame: Baseline and post-intervention (approx. 2 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 26 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with ICU-acquired Weakness, run by Asan Medical Center at 1 site in South Korea.
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 2 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 South Korea. 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 Won Kim, ph.D. (82+2-3010-1694, duocl79@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session Adherence Rate (time frame: From the first intervention session (Game 1) through the tenth session (Game 10), up to 3 weeks). The study lists 2 primary outcomes in all. 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 26 Oct 2026.