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Completed

NCT Number: NCT04687293

Rehabiliation Using HUBER 360 to Reduce the Risk of Falls

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Liège, CNRF

Tinlot, Liège, 4557, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Risk of falls, in seconds

    Time frame: 8 weeks

    Measured with Timed-Up-and Go test

Secondary outcomes

  1. Physical performance

    Time frame: 8 weeks

    Short Physical Performance Battery test (SPPB test). The test is scored from 0 (lower physical performance) to 12 (highest physical performance)

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

    Time frame: 8 weeks

    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).

  3. Utility score using the EuroQol- 5 Dimension questionnaire

    Time frame: 8 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study 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

Acronym: HUBER-FALLS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2020
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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