Rehabiliation Using HUBER 360 to Reduce the Risk of Falls

NCT04687293 | Completed DMC

• 1 other identifier: HUBER_CNRF01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Huber

Outcome Measures

Primary Outcomes (1)

• Risk of falls, in seconds

  Measured with Timed-Up-and Go test

  8 weeks

Secondary Outcomes (3)

• Physical performance

  8 weeks

• Quality of life, measured with the Short Form-36 questionnaire

  8 weeks

• Utility score using the EuroQol- 5 Dimension questionnaire

  8 weeks

Study Arms (2)

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.

Device: HUBER (LPG Systems, France)

Control

NO INTERVENTION

The control group will not received any intervention except usual care.

Interventions

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.

HUBER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF
• Patient presenting a pathological situation justifying functional rehabilitation with HUBER 360®
• Patient giving informed consent to research.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU Liège, CNRF

Tinlot, Liège, 4557, Belgium

Location

Study Officials

• Jean-François Kaux, MD PhD

  Centre Hospitalier Universitaire de Liege

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 29, 2020
• Study Start: December 9, 2020
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)