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CompletedNCT03307265Updated Jul 30, 2018

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

An interventional study of Personalized weighted jacket and Control jacket in Balance; Distorted, sponsored by Bernard Dachy. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-30.

Sponsored by Bernard Dachy · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Balance; Distorted

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Keywords

  • Weighted Jacket
  • Balance disorder
  • Equilibrium disorder
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Imbalance correction

    Device: Personalized weighted jacket

  • Active comparator
    Control

    Device: Control jacket

Interventions

  • DevicePersonalized 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.

  • DeviceControl jacket

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

05

What researchers measure

Primary outcomes

  1. Imbalance

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

    Time frame: Data measured after 2 hours of jacket utilisation

  2. Time Up and Go

    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.

    Time frame: Data measured after 2 hours of jacket utilisation

  3. Tinetti test

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

    Time frame: Data measured after 2 hours of jacket utilisation

  4. Berg balance scale

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

    Time frame: Data measured after 2 hours of jacket utilisation

Secondary outcomes

  1. Imbalance

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

    Time frame: 1 week after jacket utilisation

  2. Time Up and Go

    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.

    Time frame: 1 week after jacket utilisation

  3. Tinetti test

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

    Time frame: 1 week after jacket utilisation

  4. Berg balance scale

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

    Time frame: 1 week after jacket utilisation

06

Study locations

1 site
  • CHU Brugmann
    Brussel, 1020, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03307265
Lead sponsor
Bernard Dachy
Responsible party
Bernard Dachy (Head of neurology department, Brugmann University Hospital) — Sponsor-investigator
First posted
Oct 11, 2017
Start date
Sep 12, 2017
Primary completion
Jul 27, 2018
Completion
Jul 27, 2018
Last update
Jul 30, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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