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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03307265
Recruitment Status : Completed
First Posted : October 11, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Bernard Dachy, Brugmann University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Balance; Distorted Device: Personalized weighted jacket Device: Control jacket Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Impact of the Use of a Weighted Jacket on the Balance (While Walking or Standing) of Patients With a Balance Disorder.
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : July 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Imbalance correction Device: Personalized weighted jacket
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.

Active Comparator: Control Device: Control jacket
Patients in this group will wear a jacket with weights (200 grams maximum) evenly distributed.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307265


Locations
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Belgium
CHU Brugmann
Brussel, Belgium, 1020
Sponsors and Collaborators
Bernard Dachy

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Responsible Party: Bernard Dachy, Head of neurology department, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03307265    
Other Study ID Numbers: CHUB-Weighted jacket
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bernard Dachy, Brugmann University Hospital:
Weighted Jacket
Balance disorder
Equilibrium disorder
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms