Dual Task Training in Elderly Using the BioRescue

Mild Cognitive Impairment Clinical Trial

Official title:

What is the Influence of Dualtask-training With the BioRescue (Analyses and Rehabilitation of Mobility) on Static Balance, Dynamic Balance During Gait and Cognitive-motor Dual Tasks During Gait: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681354
• Other study ID #: 2015-PFE-JSP-01
• Status: Completed
• Phase: N/A
• First received: July 6, 2015
• Last updated: June 13, 2016
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Mild cognitive impairment (MCI) is accompanied by gait and balance problems while dual tasking. During a 6 to 8 weeks training with the BioRescue (virtual reality), institutionalized elderly people with MCI will relearn dual tasks in combination with balance. Afterwards, the transferring effect on gait in general, balance and cognition will be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• minimum age: 65

• Participants with increased fall-risk (i.e. Timed Up-and-Go Test (TUG) > 20 sec)

• Participants with Mild Cognitive Impairment (MCI) measured by the Montreal Cognitive Assessment (MoCa < 25). MCI: A state of altered cognition, characterized by a decline in one or more cognitive domains, typically including memory while the independence for daily activities remains intact.

• Participants have a positive result on the 'Stops Walking While Talking' test

Exclusion Criteria:

• Diagnosis of Dementia, based on a specialized diagnostic bilan of a doctor-specialist.

• In rehabilitation for a recent injury or recent prothesis of the upper or lower extremities.

• Serious limitations of the lower and or upper limb.

• Not able to walk more than 10 meters independently (walking-aid allowed).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Other:
• Biorescue training

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek
Belgium	Woon- en zorgcentrum Sint Elisabeth	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static balance	measured using the BioRescue	day 1	No
Primary	Static balance	measured using the BioRescue	week 8	No
Primary	Dynamic Balance	instrumented timed Up-and-Go test	day 1	No
Primary	Dynamic Balance	instrumented timed Up-and-Go test	week 8	No
Primary	instrumented timed Up-and-Go test while dual-tasking	instrumented timed Up-and-Go test while dual-tasking	day 1	No
Primary	instrumented timed Up-and-Go test while dual-tasking	instrumented timed Up-and-Go test while dual-tasking	week 8	No
Primary	"stops walking while talking" test	"stops walking while talking" test	day 1	No
Primary	"stops walking while talking" test	"stops walking while talking" test	week 8	No
Secondary	fall incidence	The incidence of falls for each participant will be registered in the institution	up to 8 weeks	No
Secondary	cognitive function	measured by the MOCA (Montreal Cognitive Assesment)	day 1	No
Secondary	cognitive function	measured by the MOCA (Montreal Cognitive Assesment)	week 8	No