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

NCT03307265 | Completed

• 1 other identifier: CHUB-Weighted jacket
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Balance; Distorted

Keywords

Weighted Jacket; Balance disorder; Equilibrium disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Imbalance

  1 week after jacket utilisation

• Time Up and Go

  1 week after jacket utilisation

• Tinetti test

  1 week after jacket utilisation

• Berg balance scale

  1 week after jacket utilisation

Study Arms (2)

Imbalance correction

EXPERIMENTAL

Device: Personalized weighted jacket

Control

ACTIVE COMPARATOR

Device: Control jacket

Interventions

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.

Imbalance correction

Control jacket DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bernard Dachy: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of neurology department

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 11, 2017
• Study Start: September 12, 2017
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)