Rehabiliation Using HUBER 360 to Reduce the Risk of Falls

Quality of Life Clinical Trial

— HUBER-FALLS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687293
• Other study ID #: HUBER_CNRF01
• Status: Completed
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: November 2, 2022

Study information

• Verified date: May 2023
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 ;

• 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.

Related Conditions & MeSH terms

• Exercise Therapy
• Fall
• Quality of Life
• Rehabilitation
• Treatment Outcome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	CHU Liège, CNRF	Tinlot	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of falls, in seconds	Measured with Timed-Up-and Go test	8 weeks
Secondary	Physical performance	Short Physical Performance Battery test (SPPB test). The test is scored from 0 (lower physical performance) to 12 (highest physical performance)	8 weeks
Secondary	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).	8 weeks
Secondary	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).	8 weeks