Functional DeclineROBUSTNCT05782855
ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion
A study testing Active Robot assisted physical training during acute hospitalisation and Passive Robot assisted physical training during acute hospitalisation in people with Functional Decline and ADL, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients. Design: blinded RCT. Patients: n = 488. Primary outcome is functional decline, assessed by Barthel-Index and 30s chair stand test. One- and three months follow-up. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Functional Decline, ADL, Physical Inactivity
- What is being tested?
- Active Robot assisted physical training during acute hospitalisation and Passive Robot assisted physical training during acute hospitalisation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 488 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2023to 31 Jul 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥65 years of age
- Able to ambulate before hospitalisation (with/without assistance)
- Able to communicate with the research team
- Expected length of stay ≥2 days
- Residing on Funen, Denmark
Who cannot join
- Able to ambulate without assistance during current hospitalisation
- Known severe dementia
- Positive Confusion and Assessment Method score (20)
- Patients who have received less than 3 training sessions at discharge
- Terminal illness
- Recent major surgery or lower extremity bone fracture in the last 3 months
Show all 10Show fewer
- Conditions contradicting use of ROBERT (unstable vertebral-, pelvic, or lower extremity fractures; high intracranial pressure; pressure ulcers or risk of developing pressure ulcers due to fragile skin; patients with medical instability)
- Metastases at femur or hip
- Deemed not suitable for mobilization sessions with the robot by the healthcare professional
- If the patient weighs more than 165 kg (the robot cannot lift the leg if the patient is severely overweight)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion (ROBUST) - a Randomised Controlled Trial
This study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients.
Design: blinded RCT. Patients: n = 488. Primary outcome is functional decline, assessed by Barthel-Index and 30s chair stand test. One- and three months follow-up.
Read the detailed description
Introduction:
Inactivity during hospitalisation is associated with significant risk of functional decline especially in older patients. This have major impact on the individual level due to decreased wellbeing and higher level of dependency and on the society level due to increased caregiver burden following hospital discharge. This study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients.
Methods:
ROBUST is a blinded RCT. Patients (n = 488) admitted with acute medical illness to Department of Geriatric Medicine, Odense University Hospital will be randomised to usual care and robot assisted active strength training of lower extremities twice daily (intervention group) or usual care and robot assisted passive sham training (control group) until discharge. Both groups will receive protein supplements.
Inclusion criteria: ≥65 years of age, able to ambulate before hospitalisation, expected length of stay ≥2 days.
Exclusion criteria: Able to ambulate without assistance during current hospitalisation, severe dementia, delirium, conditions contradicting robot training.
The primary outcome, functional decline, will be assessed by Barthel-Index and 30s chair stand test.
Secondary outcomes include Quality of life (EQ-5D), Geriatric Depression Scale, Fear of falling (FES-I), cognition (MMSE), qualitative interviews, falls, caregiver burden, discharge destination, readmissions, healthcare costs, sarcopenia, and mortality.
Outcomes will be assessed at admission, discharge, and one- and three months follow-up. Data on comorbidity, medications, blood samples, and clinical frailty scale will be collected.
Discussion: This study will investigate the effects of in-hospital robot assisted strength training on functional status in older patients with multimorbidity.
- Conditions
- Functional Decline, ADL, Physical Inactivity, Acute Illness
- Being tested
- Active Robot assisted physical training during acute hospitalisation, Passive Robot assisted physical training during acute hospitalisation
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Robot assisted physical training during acute hospitalisationOther
Active training is delivered by an innovative training robot (ROBERT®). The robot is handled by staff who attaches the robot to the patient's leg. The staff programs the exercise movement, whereby the robot remembers the movement. The robot holds the patient's leg and perform extension of hip and knee. The patient must use their muscular power to stretch the leg while ROBERT® provides resistance.
Training is defined as a minimum of three sessions before discharge.
Passive Robot assisted physical training during acute hospitalisationOther
Passive training is delivered by an innovative training robot (ROBERT®). The robot is handled by staff who attaches the robot to the patient's leg. The staff programs the movement, whereby the robot remembers the movement. The robot holds the patient's leg and perform passive extension of hip and knee. ROBERT® moves the leg independently without the patient using any muscle power.
Training is defined as a minimum of three sessions before discharge.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Participants in the control group will receive usual individualized training with a physiotherapist and passive sham training of lower extremities with the rehabilitation robot twice a day until day of discharge. The physiotherapist will be blinded to allocation. Sham training consists of 3 sets of 8 passive repetitions with each leg twice a day. Receives: Other: Passive Robot assisted physical training during acute hospitalisation |
| Intervention group | Active comparator | The intervention group will receive usual individualized training with a physiotherapist and active strength training of lower extremities by the robot twice a day until day of discharge. The physiotherapist will be blinded to allocation. Training will focus on the muscle groups in the lower extremities, which are used to get up from a chair and walk around (thigh- and calf muscles). Active training consists of 3 sets of maximum repetitions with a minimum of 65% (65-80%) intensity of 1 RM with each leg twice a day. Receives: Other: Active Robot assisted physical training during acute hospitalisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Barthel Index 100
Functional evaluation assessed by Barthel Index 100. The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.
Measured: Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)
Change from baseline 30 Second Sit to Stand Test
Functional evaluation assessed by 30 Second Sit to Stand Test . The 30 Second Sit to Stand Test is for testing leg strength and endurance in older adults.
Measured: Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)
Secondary outcomes (16)
Quality of life EQ-5D
Quality of life is assessed using the questionaire Quality of life EuroQol-5 dimension (EQ-5D). The EQ-5D comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each with three levels (no problems, some problems, extreme problems/unable), thus generating 243 possible health states.
The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Measured: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Mood status
Mood status are assessed by the 15-item Geriatric Depression Scale. The Short Form GDS consisting of 15 questions. Of the 15 items, 10 indicated the presence of depression when answered positively, while the rest indicated depression when answered negatively. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Measured: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Concern about falling including number of falls
Concern about falling is assessed using the 16-item Short Falls Efficacy Scale International (Short FES-I) questionaire. To calculate the Short FES-I score when all items are completed, simply add the scores for each item together to give a total that ranges as follows: minimum 7 (no concern about falling) to maximum 28 (severe concern about falling).
Measured: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Patient perspective by qualitative interviews
Qualitative semi-structured in-depth interviews will be performed with at least 12 patients at discharge and 1 month follow-up to explore their perspectives and experiences (PRO/PRE). The qualitative interviews will provide further and deeper explanations of the results from the quantitative parts of the study. By using this mixed-methods approach the research results will be strengthen by the complementary findings. The analysis of the qualitative data will be completed in line with manifest content analysis by Graneheim and Lundman. Data will be handled using the software NVivo
Measured: Day of hospital discharge (an average of 1 week); 1 month follow-up.
Cognitive function
Cognitive function is assessed by the Mini Mental State Examination. The Mini-Mental State Examination (MMSE) is a set of 11 questions that is used to check for cognitive impairment (problems with thinking, communication, understanding and memory). The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
Measured: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Muscle quantity
Muscle quantity is assessed using bioelectrical impedance by InBodyS10. Bioelectrical impedance analysis (BIA) is a method for estimating body composition, in particular body fat and muscle mass.
Measured: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Sarcopenia
Sarcopenia is assessed based on the 2019 European guidelines by Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère O, Cederholm T, et al.
Measured: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Need of care at home
Individual level data from the municipalities will be used to assess amount of need of care/home care provided by the municipality 3 months before admission and 3 months after discharge. Need of care at home is devided in the following categories: practical help, personnel care, nursing and training. Amount of need of care will be presented in hours.
Measured: From 3 months prior to day of hospital admission to 3 months following day of hospital discharge.
Length of hospital stay
Length of hospital stay will be defined as number of days in geriatric department.
Measured: From day of hospital admission to day of hospital discharge (an average of 1 week).
Discharge destination
Data about discharge destination will be collected at the day of discharge (own home, temporary rehabilitation units, nursing homes)
Measured: Day of hospital discharge (an average of 1 week).
Rate of hospital readmission
Patients will be followed through a review of medical records for any unplanned hospitalisation within 1 month after discharge.
Readmission definition: any unplanned hospital contact with a duration of 12+hours, occurring between 4 hours and 30 days after discharge from the Department of Geriatric Medicine.
Measured: 30 days following day of hospital discharge.
Health care cost evaluation
A researcher in health care economics will perform a health care cost evaluation addressing running cost using ROBERT, discharge destination, hospital readmissions, care giver burden, and visits to the general practitioner after 3 months.
Measured: 3 months follow-up.
Mortality
Administrative registers will be used to assess mortality at 1- and 3- months follow-up.
Measured: 1- and 3-months follow-up.
Change from baseline Barthel Index 100
Functional evaluation assessed by Barthel Index 100. The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.
Measured: Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.
Change from baseline 30 Second Sit to Stand Test
Functional evaluation assessed by 30 Second Sit to Stand Test . The 30 Second Sit to Stand Test is for testing leg strength and endurance in older adults.
Measured: Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.
Clinical Frailty Scale
The 9-point Clinical Frailty Scale (CFS) with pictograms is used at baseline before randomisation, at discharge, and at 1- and 3-month follow-up (28) to examine the impact of the exercise intervention on frailty and to determine the impact of baseline frailty on the effectiveness of the intervention
Measured: Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start5 Jan 2023
- Primary completion20 Dec 2024
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Functional DeclineStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Ryg, Odense University Hospital
- Investigators
- Jesper Ryg, Professor, Principal investigator, Department of geriatric medicine Odense University hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782855
- Sponsor's protocol ID
- ROBUST
- Acronym
- ROBUST
- Status last verified
- Sep 2025
- First submitted
- 27 Dec 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertelsen AS, Storm A, Minet L, Ryg J. Use of robot technology in passive mobilization of acute hospitalized geriatric medicine patients: a pilot test and feasibility study. Pilot Feasibility Stud. 2020 Jan 6;6:1. doi: 10.1186/s40814-019-0545-z. eCollection 2020.
PubMed 31921434Bertelsen AS, Ryg J, Masud T, Suetta C, Minet LR. Robot-Assisted Physical Exercise in Acutely Hospitalised Geriatric Patients: Insights From the ROBUST RCT - A Case Report. Int Med Case Rep J. 2026 Jan 24;19:558654. doi: 10.2147/IMCRJ.S558654. eCollection 2026.
PubMed 41867392Bertelsen AS, Masud T, Suetta C, Rosenbek Minet L, Andersen S, Lauridsen JT, Ryg J. ROBot-assisted physical training of older patients during acUte hospitaliSaTion-study protocol for a randomised controlled trial (ROBUST). Trials. 2024 Apr 4;25(1):235. doi: 10.1186/s13063-024-08044-6.
PubMed 38576046
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion (ROBUST) - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05782855
- Acronym / sponsor ID
- ROBUST / ROBUST
- Conditions
- Functional Decline, ADL, Physical Inactivity, Acute Illness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Mar 2023 (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 study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients.
Design: blinded RCT. Patients: n = 488. Primary outcome is functional decline, assessed by Barthel-Index and 30s chair stand test. One- and three months follow-up.
Detailed description
Introduction:
Inactivity during hospitalisation is associated with significant risk of functional decline especially in older patients. This have major impact on the individual level due to decreased wellbeing and higher level of dependency and on the society level due to increased caregiver burden following hospital discharge. This study aims to address if robot assisted physical training can prevent functional decline during acute hospitalisation in older geriatric patients.
Methods:
ROBUST is a blinded RCT. Patients (n = 488) admitted with acute medical illness to Department of Geriatric Medicine, Odense University Hospital will be randomised to usual care and robot assisted active strength training of lower extremities twice daily (intervention group) or usual care and robot assisted passive sham training (control group) until discharge. Both groups will receive protein supplements.
Inclusion criteria: ≥65 years of age, able to ambulate before hospitalisation, expected length of stay ≥2 days.
Exclusion criteria: Able to ambulate without assistance during current hospitalisation, severe dementia, delirium, conditions contradicting robot training.
The primary outcome, functional decline, will be assessed by Barthel-Index and 30s chair stand test.
Secondary outcomes include Quality of life (EQ-5D), Geriatric Depression Scale, Fear of falling (FES-I), cognition (MMSE), qualitative interviews, falls, caregiver burden, discharge destination, readmissions, healthcare costs, sarcopenia, and mortality.
Outcomes will be assessed at admission, discharge, and one- and three months follow-up. Data on comorbidity, medications, blood samples, and clinical frailty scale will be collected.
Discussion: This study will investigate the effects of in-hospital robot assisted strength training on functional status in older patients with multimorbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Passive Robot assisted physical training during acute hospitalisationParticipants in the control group will receive usual individualized training with a physiotherapist and passive sham training of lower extremities with the rehabilitation robot twice a day until day of discharge. The physiotherapist will be blinded to allocation. Sham training consists of 3 sets of 8 passive repetitions with each leg twice a day. |
| Intervention group | Active comparator | Other: Active Robot assisted physical training during acute hospitalisationThe intervention group will receive usual individualized training with a physiotherapist and active strength training of lower extremities by the robot twice a day until day of discharge. The physiotherapist will be blinded to allocation. Training will focus on the muscle groups in the lower extremities, which are used to get up from a chair and walk around (thigh- and calf muscles). Active training consists of 3 sets of maximum repetitions with a minimum of 65% (65-80%) intensity of 1 RM with each leg twice a day. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- ≥65 years of age
- Able to ambulate before hospitalisation (with/without assistance)
- Able to communicate with the research team
- Expected length of stay ≥2 days
- Residing on Funen, Denmark
Key exclusion criteria (10 listed)
- Able to ambulate without assistance during current hospitalisation
- Known severe dementia
- Positive Confusion and Assessment Method score (20)
- Patients who have received less than 3 training sessions at discharge
- Terminal illness
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 |
|---|---|---|
| Active Robot assisted physical training during acute hospitalisationActive training is delivered by an innovative training robot (ROBERT®). The robot is handled by staff who attaches the robot to the patient's leg. The staff programs the exercise movement, whereby the robot remembers the movement. The robot holds the patient's leg and perform extension of hip and knee. The patient must use their muscular power to stretch the leg while ROBERT® provides resistance. Training is defined as a minimum of three sessions before discharge. | Other | Intervention group |
| Passive Robot assisted physical training during acute hospitalisationPassive training is delivered by an innovative training robot (ROBERT®). The robot is handled by staff who attaches the robot to the patient's leg. The staff programs the movement, whereby the robot remembers the movement. The robot holds the patient's leg and perform passive extension of hip and knee. ROBERT® moves the leg independently without the patient using any muscle power. Training is defined as a minimum of three sessions before discharge. | Other | Control group |
Primary outcome
Change from baseline Barthel Index 100
Time frame: Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)
Functional evaluation assessed by Barthel Index 100. The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.
Change from baseline 30 Second Sit to Stand Test
Time frame: Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)
Functional evaluation assessed by 30 Second Sit to Stand Test . The 30 Second Sit to Stand Test is for testing leg strength and endurance in older adults.
16 secondary outcomes
Quality of life EQ-5D
Time frame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Mood status
Time frame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Concern about falling including number of falls
Time frame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Patient perspective by qualitative interviews
Time frame: Day of hospital discharge (an average of 1 week); 1 month follow-up.
Cognitive function
Time frame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Muscle quantity
Time frame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Sarcopenia
Time frame: Day of hospital admission; day of hospital discharge (an average of 1 week); 1 month follow-up; 3 months follow-up.
Need of care at home
Time frame: From 3 months prior to day of hospital admission to 3 months following day of hospital discharge.
Length of hospital stay
Time frame: From day of hospital admission to day of hospital discharge (an average of 1 week).
Discharge destination
Time frame: Day of hospital discharge (an average of 1 week).
Rate of hospital readmission
Time frame: 30 days following day of hospital discharge.
Health care cost evaluation
Time frame: 3 months follow-up.
Mortality
Time frame: 1- and 3-months follow-up.
Change from baseline Barthel Index 100
Time frame: Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.
Change from baseline 30 Second Sit to Stand Test
Time frame: Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.
Clinical Frailty Scale
Time frame: Change from baseline (day of hospital admission) to 1 month follow-up and 3 months follow-up.
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 8 Sep 2025.
- Background: PubMed 31921434Bertelsen AS, Storm A, Minet L, Ryg J. Use of robot technology in passive mobilization of acute hospitalized geriatric medicine patients: a pilot test and feasibility study. Pilot Feasibility Stud. 2020 Jan 6;6:1. doi: 10.1186/s40814-019-0545-z. eCollection 2020.
- Derived from this study: PubMed 41867392Bertelsen AS, Ryg J, Masud T, Suetta C, Minet LR. Robot-Assisted Physical Exercise in Acutely Hospitalised Geriatric Patients: Insights From the ROBUST RCT - A Case Report. Int Med Case Rep J. 2026 Jan 24;19:558654. doi: 10.2147/IMCRJ.S558654. eCollection 2026.
- Derived from this study: PubMed 38576046Bertelsen AS, Masud T, Suetta C, Rosenbek Minet L, Andersen S, Lauridsen JT, Ryg J. ROBot-assisted physical training of older patients during acUte hospitaliSaTion-study protocol for a randomised controlled trial (ROBUST). Trials. 2024 Apr 4;25(1):235. doi: 10.1186/s13063-024-08044-6.
- 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. This study is not recruiting at the moment.
Jesper Ryg, Professor principal investigator
Department of geriatric medicine Odense University hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Robot assisted physical training during acute hospitalisation and Passive Robot assisted physical training during acute hospitalisation in people with Functional Decline and ADL, run by Odense University Hospital at 1 site in Denmark.
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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Barthel Index 100 (time frame: Change from baseline (day of hospital admission) to day of hospital discharge (an average of 1 week)). 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?
On the ClinicalTrials.gov record for NCT05782855, which also lists 3 linked publications.
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 8 Sep 2025.