RehabilitationHUBER-FALLSNCT04687293
Rehabiliation Using HUBER 360 to Reduce the Risk of Falls
A study testing HUBER (LPG Systems, France) in people with Rehabilitation and Exercise Therapy, run by University of Liege at 1 site in Belgium.
Trial summary
Aim: The aim of the present study was to analyse the effects of training performed on a rotating, motorised platform (the Huber/SpineForce device from LPG Systems, Valence, France) intended to reduce the risk of falls. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rehabilitation, Exercise Therapy, Treatment Outcome
- What is being tested?
- HUBER (LPG Systems, France)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Dec 2020to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF
- Patient presenting a pathological situation justifying functional rehabilitation with HUBER 360®
- Patient presenting any pathology not constituting an exclusion criterion
- Patient giving informed consent to research.
Who cannot join
- Cardiac or respiratory or neurological or rheumatological disease incompatible with physical activity ;
- Joint inflammation;
- Rheumatic disease in acute phase;
- Recent trauma, infection of the musculoskeletal system;
- Fever;
- Venous thrombosis ;
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- Discopathy in acute phase;
- Neuropsychological problems that do not allow to integrate the instructions or other serious psychological problems;
- Cardiovascular diseases and any progressive, chronic, counter-indicative disease;
- Large anatomical deformities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Rehabilitation Using the HUBER 360 Tool to Reduce the Risk of Falls in People in Pathological Situations Requiring Functional Rehabilitation
Aim: The aim of the present study was to analyse the effects of training performed on a rotating, motorised platform (the Huber/SpineForce device from LPG Systems, Valence, France) intended to reduce the risk of falls.
Subjects: any patient 1) benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF, Belgium; 2) presenting a pathological situation justifying functional rehabilitation with HUBER 360®; 3) presenting any pathology not constituting an exclusion criterion; 4) giving informed consent to research will be include in this 8-week interventional trial.
Read more
Design: randomized open-label trial. Patients will be randomized into the intervention group (HUBER trainig, 45 minutes of training, twice a week during 8 weeks) or in the control group (standard care).
Outcomes: the effect of the training will be measured on the Time-Up-and-Go test, on the Short-Physical performance battery test and on quality of life.
- Conditions
- Rehabilitation, Exercise Therapy, Treatment Outcome, Quality of Life, Fall
- Being tested
- HUBER (LPG Systems, France)
- Keywords
- Huber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUBER (LPG Systems, France)Device
The HUBER® device consists of an oval motorized platform, which performs rotating, oscillatory movements with a controlled amplitude and speed. It also comprises, two large handles with force sensors, mounted on a movable column. Its originality is based on its capacity to capture simultaneously the subjects' balance, core stability, core strength and total body strength; and adapt the training accordingly. Indeed, the platform interferes with the balance of the patient who must continually adjust his/her posture by exerting isometric pushing and pulling efforts with the arms. As a result, the device provides postural and muscle adaptation with visual feedback. Due to the constant adaptation of the device, it is thought to enhance muscular strength and improve neuromuscular coordination simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| HUBER | Experimental | HUBER is an isometric strengthening device. It consists of an oval motorized platform, which performs rotating, oscillatory movements with a controlled amplitude and speed.
Intervention will consist of 2 sessions of HUBER per week. Each session lasts approximatively 30 minutes. The intervention is 8 weeks long. Receives: Device: HUBER (LPG Systems, France) |
| Control | No intervention | The control group will not received any intervention except usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of falls, in seconds
Measured with Timed-Up-and Go test
Measured: 8 weeks
Secondary outcomes (3)
Physical performance
Short Physical Performance Battery test (SPPB test). The test is scored from 0 (lower physical performance) to 12 (highest physical performance)
Measured: 8 weeks
Quality of life, measured with the Short Form-36 questionnaire
SF-36 generic quality of life questionnaire. The score obtained from this questionnaire is composed with a Physcial component Scale (PMS) and a Mental component scale (MCS). Results are scored from 0 (worst quality of life) to 100 (best quality of life).
Measured: 8 weeks
Utility score using the EuroQol- 5 Dimension questionnaire
Descriptive data from the 5 dimensions can be used to generate a health-related quality of life profile for the subject. The questionnaire is scored from 0 (worst health state imaginable) to 100 (best health state imaginable).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start9 Dec 2020
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Beaudart, University of Liege
- Investigators
- Jean-François Kaux, MD PhD, Study director, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687293
- Sponsor's protocol ID
- HUBER_CNRF01
- Acronym
- HUBER-FALLS
- Status last verified
- May 2023
- First submitted
- 9 Dec 2020
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Rehabilitation Using the HUBER 360 Tool to Reduce the Risk of Falls in People in Pathological Situations Requiring Functional Rehabilitation
- ClinicalTrials.gov ID
- NCT04687293
- Acronym / sponsor ID
- HUBER-FALLS / HUBER_CNRF01
- Conditions
- Rehabilitation, Exercise Therapy, Treatment Outcome, Quality of Life, Fall
- Keywords
- Huber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 29 Dec 2020 (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.
Aim: The aim of the present study was to analyse the effects of training performed on a rotating, motorised platform (the Huber/SpineForce device from LPG Systems, Valence, France) intended to reduce the risk of falls.
Subjects: any patient 1) benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF, Belgium; 2) presenting a pathological situation justifying functional rehabilitation with HUBER 360®; 3) presenting any pathology not constituting an exclusion criterion; 4) giving informed consent to research will be include in this 8-week interventional trial.
Design: randomized open-label trial. Patients will be randomized into the intervention group (HUBER trainig, 45 minutes of training, twice a week during 8 weeks) or in the control group (standard care).
Outcomes: the effect of the training will be measured on the Time-Up-and-Go test, on the Short-Physical performance battery test and on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HUBER | Experimental | Device: HUBER (LPG Systems, France)HUBER is an isometric strengthening device. It consists of an oval motorized platform, which performs rotating, oscillatory movements with a controlled amplitude and speed. Intervention will consist of 2 sessions of HUBER per week. Each session lasts approximatively 30 minutes. The intervention is 8 weeks long. |
| Control | No intervention | –The control group will not received any intervention except usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF
- Patient presenting a pathological situation justifying functional rehabilitation with HUBER 360®
- Patient presenting any pathology not constituting an exclusion criterion
- Patient giving informed consent to research.
Key exclusion criteria (10 listed)
- Cardiac or respiratory or neurological or rheumatological disease incompatible with physical activity ;
- Joint inflammation;
- Rheumatic disease in acute phase;
- Recent trauma, infection of the musculoskeletal system;
- Fever;
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 |
|---|---|---|
| HUBER (LPG Systems, France)The HUBER® device consists of an oval motorized platform, which performs rotating, oscillatory movements with a controlled amplitude and speed. It also comprises, two large handles with force sensors, mounted on a movable column. Its originality is based on its capacity to capture simultaneously the subjects' balance, core stability, core strength and total body strength; and adapt the training accordingly. Indeed, the platform interferes with the balance of the patient who must continually adjust his/her posture by exerting isometric pushing and pulling efforts with the arms. As a result, the device provides postural and muscle adaptation with visual feedback. Due to the constant adaptation of the device, it is thought to enhance muscular strength and improve neuromuscular coordination simultaneously. | Device | HUBER |
Primary outcome
Risk of falls, in seconds
Time frame: 8 weeks
Measured with Timed-Up-and Go test
3 secondary outcomes
Physical performance
Time frame: 8 weeks
Quality of life, measured with the Short Form-36 questionnaire
Time frame: 8 weeks
Utility score using the EuroQol- 5 Dimension questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- 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.
Jean-François Kaux, MD PhD study director
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HUBER (LPG Systems, France) in people with Rehabilitation and Exercise Therapy, run by University of Liege at 1 site in Belgium.
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 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: finished, as of the sponsor's last update on 12 May 2023. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Risk of falls, in seconds (time frame: 8 weeks). 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 12 May 2023.