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

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

Study Overview

• Status: Completed
• Conditions: Balance; Distorted
• Intervention / Treatment: Device: Personalized weighted jacket; Device: Control jacket

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Device: Control jacket; Patients in this group will wear a jacket with weights (200 grams maximum) evenly distributed.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imbalance	The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.	Data measured after 2 hours of jacket utilisation
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.	Data measured after 2 hours of jacket utilisation
Tinetti test	The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.	Data measured after 2 hours of jacket utilisation
Berg balance scale	The Berg balance scale includes 14 tests that assess static balance and dynamic balance.	Data measured after 2 hours of jacket utilisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imbalance	The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.	1 week after jacket utilisation
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.	1 week after jacket utilisation
Tinetti test	The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.	1 week after jacket utilisation
Berg balance scale	The Berg balance scale includes 14 tests that assess static balance and dynamic balance.	1 week after jacket utilisation

Collaborators and Investigators

• Sponsor: Bernard Dachy

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): July 27, 2018
• Study Completion (Actual): July 27, 2018

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Balance disorder; Weighted Jacket; Equilibrium disorder
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: CHUB-Weighted jacket

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No