Rehabiliation Using HUBER 360 to Reduce the Risk of Falls (HUBER-FALLS)

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.

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 Overview

• Status: Completed
• Conditions: Quality of Life; Rehabilitation; Fall; Exercise Therapy; Treatment Outcome
• Intervention / Treatment: Device: HUBER (LPG Systems, France)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège
    • Tinlot, Liège, Belgium, 4557
      • CHU Liège, CNRF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HUBER; 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.	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.
No Intervention: Control; The control group will not received any intervention except usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of falls, in seconds	Measured with Timed-Up-and Go test	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Study Director: Jean-François Kaux, MD PhD, Centre Hospitalier Universitaire de Liège

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Huber
• Other Study ID Numbers: HUBER_CNRF01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No