Mild Cognitive ImpairmentNCT02681354
Dual Task Training in Elderly Using the BioRescue
A study testing Biorescue training in people with Mild Cognitive Impairment, run by Hasselt University at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Biorescue training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesBelgium
- Study dates
- Nov 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Hasselt University
Diepenbeek, 3560
Woon- en zorgcentrum Sint Elisabeth
Hasselt, 3500
About this study
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
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Biorescue training
- Keywords
- elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biorescue trainingOther
| Study group | Role | What they receive |
|---|---|---|
| A additional BioRescue training | Experimental | Using a playful rehabilitation, BioRescue Receives: Other: Biorescue training |
| Regular training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance
measured using the BioRescue
Measured: day 1
Static balance
measured using the BioRescue
Measured: week 8
Dynamic Balance
instrumented timed Up-and-Go test
Measured: day 1
Dynamic Balance
instrumented timed Up-and-Go test
Measured: week 8
instrumented timed Up-and-Go test while dual-tasking
instrumented timed Up-and-Go test while dual-tasking
Measured: day 1
instrumented timed Up-and-Go test while dual-tasking
instrumented timed Up-and-Go test while dual-tasking
Measured: week 8
"stops walking while talking" test
"stops walking while talking" test
Measured: day 1
"stops walking while talking" test
"stops walking while talking" test
Measured: week 8
Secondary outcomes (3)
fall incidence
The incidence of falls for each participant will be registered in the institution
Measured: up to 8 weeks
cognitive function
measured by the MOCA (Montreal Cognitive Assesment)
Measured: day 1
cognitive function
measured by the MOCA (Montreal Cognitive Assesment)
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feys, prof. dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681354
- Sponsor's protocol ID
- 2015-PFE-JSP-01
- Status last verified
- Jun 2016
- First submitted
- 6 Jul 2015
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02681354
- Acronym / sponsor ID
- 2015-PFE-JSP-01
- Conditions
- Mild Cognitive Impairment
- Keywords
- elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A additional BioRescue training | Experimental | Other: Biorescue trainingUsing a playful rehabilitation, BioRescue |
| Regular training | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biorescue training | Other | A additional BioRescue training |
Primary outcome
Static balance
Time frame: day 1
measured using the BioRescue
Static balance
Time frame: week 8
measured using the BioRescue
Dynamic Balance
Time frame: day 1
instrumented timed Up-and-Go test
Dynamic Balance
Time frame: week 8
instrumented timed Up-and-Go test
instrumented timed Up-and-Go test while dual-tasking
Time frame: day 1
instrumented timed Up-and-Go test while dual-tasking
instrumented timed Up-and-Go test while dual-tasking
Time frame: week 8
instrumented timed Up-and-Go test while dual-tasking
"stops walking while talking" test
Time frame: day 1
"stops walking while talking" test
"stops walking while talking" test
Time frame: week 8
"stops walking while talking" test
3 secondary outcomes
fall incidence
Time frame: up to 8 weeks
cognitive function
Time frame: day 1
cognitive function
Time frame: week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Feys, prof. dr. principal investigator
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biorescue training in people with Mild Cognitive Impairment, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance (time frame: day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.