Impact of the Use of a Weighted Jacket on the Balance of Patients With a Balance Disorder.
Primary Purpose
Balance; Distorted
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Personalized weighted jacket
Control jacket
Sponsored by
About this trial
This is an interventional treatment trial for Balance; Distorted focused on measuring Weighted Jacket, Balance disorder, Equilibrium disorder
Eligibility 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
Sites / Locations
- CHU Brugmann
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Imbalance correction
Control
Arm Description
Outcomes
Primary Outcome Measures
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 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.
Tinetti test
The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.
Berg balance scale
The Berg balance scale includes 14 tests that assess static balance and dynamic balance.
Secondary Outcome Measures
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 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.
Tinetti test
The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.
Berg balance scale
The Berg balance scale includes 14 tests that assess static balance and dynamic balance.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03307265
Brief Title
Impact of the Use of a Weighted Jacket on the Balance of Patients With a Balance Disorder.
Official Title
Impact of the Use of a Weighted Jacket on the Balance (While Walking or Standing) of Patients With a Balance Disorder.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
July 27, 2018 (Actual)
Study Completion Date
July 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bernard Dachy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Balance; Distorted
Keywords
Weighted Jacket, Balance disorder, Equilibrium disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imbalance correction
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Personalized weighted jacket
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control jacket
Intervention Description
Patients in this group will wear a jacket with weights (200 grams maximum) evenly distributed.
Primary Outcome Measure Information:
Title
Imbalance
Description
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
Title
Time Up and Go
Description
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
Title
Tinetti test
Description
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
Title
Berg balance scale
Description
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 Outcome Measure Information:
Title
Imbalance
Description
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
Title
Time Up and Go
Description
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
Title
Tinetti test
Description
The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.
Time Frame
1 week after jacket utilisation
Title
Berg balance scale
Description
The Berg balance scale includes 14 tests that assess static balance and dynamic balance.
Time Frame
1 week after jacket utilisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Brugmann
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of the Use of a Weighted Jacket on the Balance of Patients With a Balance Disorder.
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