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

Balance; Distorted Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307265
• Other study ID #: CHUB-Weighted jacket
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: July 27, 2018

Study information

• Verified date: July 2018
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Balance; Distorted
• Body Weight

Intervention

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

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Bernard Dachy

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Tinetti test	The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.	1 week after jacket utilisation
Secondary	Berg balance scale	The Berg balance scale includes 14 tests that assess static balance and dynamic balance.	1 week after jacket utilisation