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Completed

NCT Number: NCT03307265

Impact of the Use of a Weighted Jacket on the Balance of Patients With a Balance Disorder.

The aim of the study is to test whether wearing a weighted jacket can help improve the balance distortion of patients with neurologic pathologies.

The center of mass of the patient will be analyzed in order to determine the direction in which the imbalance is most important. Weights will be placed accordingly in a jacket in order to correct the imbalance. In the experimental group, weights will represent 1.5 to 2% of the patient body mass. In the control group, the investigators will use weights of 200 grams maximum, placed evenly on both sides of the jacket. Patients will wear the jacket for 2 consecutive hours.

After wearing the jacket for 2 hours, data similar to those recorded at the beginning of the experiment will be taken again, namely the determination of the center of mass and of the deviations caused by the imbalance.

A final series of tests will take place approximately one week after wearing the jacket, to determine if there are any residual effects.

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Key information

Conditions

Balance; Distorted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • good level of French understanding
  • be able to walk a minimum distance of 10 meters with or without rod/walker
  • walk 10 meters in more than 12 seconds.
  • have a diagnosis of Multiple Sclerosis, Parkinson's, or any other neurological pathology that could cause balance disorders
  • be able to endure at least 2 hours of tests, interviews or medical care.
  • score of more than 8 seconds at the time up and go (TUG), less than 24 points out of 28 in the Tinetti test

Exclusion criteria

  • the patient underwent a period of exacerbation of his pathology in the last two months (especially for multiple sclerosis patients)
  • chronic back pain
  • poor eyesight (not be able to perform the tests)
  • osteoporosis

Treatment and study plan

Personalized weighted jacket

Device

Patients in this group will wear a jacket with weights (1,5 to 2% of the total body mass) strategically placed in order to correct their imbalance.

Control jacket

Device

Patients in this group will wear a jacket with weights (200 grams maximum) evenly distributed.

Primary outcomes

  1. Imbalance

    Time frame: Data measured after 2 hours of jacket utilisation

    The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.

  2. Time Up and Go

    Time frame: Data measured after 2 hours of jacket utilisation

    The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

  3. Tinetti test

    Time frame: Data measured after 2 hours of jacket utilisation

    The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.

  4. Berg balance scale

    Time frame: Data measured after 2 hours of jacket utilisation

    The Berg balance scale includes 14 tests that assess static balance and dynamic balance.

Secondary outcomes

  1. Imbalance

    Time frame: 1 week after jacket utilisation

    The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.

  2. Time Up and Go

    Time frame: 1 week after jacket utilisation

    The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

  3. Tinetti test

    Time frame: 1 week after jacket utilisation

    The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.

  4. Berg balance scale

    Time frame: 1 week after jacket utilisation

    The Berg balance scale includes 14 tests that assess static balance and dynamic balance.

Sponsors and collaborators

Lead sponsor

Bernard Dachy

Other

Registry information

Official study title

Impact of the Use of a Weighted Jacket on the Balance (While Walking or Standing) of Patients With a Balance Disorder.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2017
Registry last updated
Jul 30, 2018

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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