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Trial registered on ANZCTR


Registration number
ACTRN12611000261910
Ethics application status
Approved
Date submitted
10/03/2011
Date registered
10/03/2011
Date last updated
10/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Quantitative Motor Assessment in patients with mild to moderate Alzheimer’s Disease
Scientific title
Quantitative Motor Assessment in patients with mild to moderate Alzheimer’s Disease
Secondary ID [1] 259766 0
Nil
Universal Trial Number (UTN)
Trial acronym
Q Motor in AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease 261342 0
Condition category
Condition code
Neurological 259497 259497 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study uses four isometric computerised motor tasks as novel objective and quantitative measures for the assessment of observable motor characteristics and dysfunction in AD.
Assessment of the variability of tongue protrusion forces, grip force, and tapping may provide objective and quantitative measures that (1) provides much needed empirical data on the motor symptoms of AD and help elucidate a motor pattern, and (2) correlates with illness
severity (thus may be a measure of disease progression).


Initials, date of birth and medical history will be recorded.

For the study, a number of examinations and tests will be completed. The study will take place in Normanby House, Kew in one visit and will take approximately one hour. The visit will involve:
a) Tests to measure mental functioning, everyday functioning, and thinking ability (MMSE)
b) A neurological examination and a rating of physical/motor function (UPDRS)
c) The four motor tasks use a force transducer sensor. All participants complete all four tasks.
Task 1.Grip force analysis task. This assesses the coordination of the grip between thumb and index finger. Both hands are tested by lifting and holding 1) a light weight, and 2) a heavy weight. Five trials of 35 seconds duration will be performed with each hand. Duration: 15 minutes.

Task 2. Grip force matching task. Participants will try to match grip to the target force on the computer (with visual feedback). Both hands are tested. Duration: 5 minutes.

Task 3. Tapping tasks. Using the index finger, participants will tap the sensor in a number of different conditions (speeded tapping, speeded tapping with serial 2s, tone paced tapping, and self-paced tapping). Duration: 5 minutes.

Task 4. Tongue force task. With their tongue on the force transducer, participants will need to match and maintain a specified force level for 20 seconds. Duration: 10 minutes.

All AD participants will be on stable dosages of AD medication for at least 6 months (any dosage), as we are screening for participants on stable AD therapy. This also limits side effect confounders.
Intervention code [1] 264192 0
Early detection / Screening
Comparator / control treatment
This study uses four isometric computerised motor tasks as novel objective and quantitative measures for the assessment of observable motor characteristics and dysfunction. Controls (20 cognitively healthy and age-matched control participants) will be compared to 20 AD participants.

Both groups (all participants) have the same protocol and will complete the same tasks and measures.
Control group
Active

Outcomes
Primary outcome [1] 262302 0
There will be different motor phenotype between AD and control participants as indicated by Task one: Grip force analysis task. This assesses the coordination of the grip between thumb and index finger.
Timepoint [1] 262302 0
Timepoint is at the end of all participant visits (n=40, 20 AD participants and 20 control participants)
Primary outcome [2] 262305 0
There will be different motor phenotype between AD and control participants as indicated by Task Two: Grip force matching task. This assesses accuracy of matching of grip to the target force on the computer (with visual feedback).
Timepoint [2] 262305 0
Timepoint is at the end of all participant visits (n=40, 20 AD participants and 20 control participants)
Primary outcome [3] 262306 0
There will be different motor phenotype between AD and control participants as indicated by Task Three: Tapping tasks (speeded tapping, speeded tapping with serial 2s, tone paced tapping, and self-paced tapping)
Timepoint [3] 262306 0
Timepoint is at the end of all participant visits (n=40, 20 AD participants and 20 control participants)
Secondary outcome [1] 273498 0
There will be different motor phenotype between AD and control participants as indicated by Task Four: Tongue force task, matching and maintaining a specified force level for 20 seconds.
Timepoint [1] 273498 0
Timepoint is at the end of all participant visits (n=40, 20 AD participants and 20 control participants)

Eligibility
Key inclusion criteria
20 cognitively healthy and age-matched control participants.

Patients with mild-to-moderate Alzheimer’s Disease (MMSE between 10-24), both women and men, who are on stable treatment. Stable treatment means that participants will be on treatment on a stable dose (any dose) for at least six months prior to the Study Day 1 (baseline visit). Treatment can be the cholinesterase inhibitors donezepil, galantamine, rivastigmine, or the NMDA glutamate blocking drug memantine.

Only individuals who are clinically free of extrapyramidal signs or parkinsonism to be included.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Control participants will be used, who will be cognitively healthy (inclusion criteria - no diagnosis of dementia)

Exclusion criteria: (1) other co-existing chronic neurological diseases, (2) arthritis or orthopedic disorders, (3) active psychosis, (4) upper extremity weakness (5) incapability of following simple verbal instructions, or (6) visual or other impairments that would interfere with completion of the tasks.
Rationale for excluding upper extremity weakness – as the experimental tasks involve gripping and tapping with the hands, we wish to exclude those with known pre-existing difficulties that would confound our results. Those with upper extremity weakness include those with weakness due to stroke, peripheral neuropathy, those with orthopaedic diagnoses, spinal cord injuries, or have any condition or reason that, in the opinion of the research team, interferes with the ability of the patient to participate in or complete the trial, which places the patient at undue risk, or complicates the interpretation of data.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All subjects receive the same study measures (two groups are controls and AD participants)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
na
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264638 0
Hospital
Name [1] 264638 0
St Vincent's Hospital (Melbourne)
Country [1] 264638 0
Australia
Primary sponsor type
University
Name
The University of Melbourne, AUPOA
Address
AUPOA
Normanby Unit
283 Cotham Rd
Kew, VICTORIA 3101
Country
Australia
Secondary sponsor category [1] 263776 0
None
Name [1] 263776 0
Address [1] 263776 0
Country [1] 263776 0
Other collaborator category [1] 251868 0
University
Name [1] 251868 0
University of Muenster
Address [1] 251868 0
Albert Schweitzer Strasse 33
48129 Muenster
Germany
Country [1] 251868 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266639 0
St Vincent's Hospital (Melbourne)
Ethics committee address [1] 266639 0
St Vincent's PO Box 2900, Fitzroy VIC 3065, Australia
Ethics committee country [1] 266639 0
Australia
Date submitted for ethics approval [1] 266639 0
Approval date [1] 266639 0
07/03/2011
Ethics approval number [1] 266639 0
1/11/0002

Summary
Brief summary
The prevalence of dementia in Australia is expected to triple by 2051. Over 165,000 Australians are affected by Alzheimer's disease (AD), and it is expected that 500,000 Australians will be diagnosed by 2040. AD is currently incurable. Motor signs of AD include problems with speech/facial expression, rigidity, balance, posture/gait, bradykinesia (slowed ability to start and continue movements), tremor, incoordination, apraxia (inability to perform coordinated movements or manipulate objects) and dysarthria (difficulty articulating words).

Current clinical rating scales lack sensitivity, have floor or ceiling effects (task items too challenging or not challenging enough), and require long observation periods to show changes. There are no known currently used quantitative assessments of motor signs in AD. This pioneering study uses four isometric motor tasks as novel objective and quantitative measures for the assessment of observable motor characteristics and dysfunction in AD. Twenty participants diagnosed with mild to moderate AD, both women and men, and 20 cognitively healthy and age-matched control participants will complete these motor tasks, in addition to tasks measuring cognitive performance and level of dementia. The performance of participants with AD will be compared to the healthy control participants.

Knowledge of the characteristics of motor signs in AD is important, given their predictive ability for rates of cognitive decline and mortality and their association with increased cost of care. Assessment of the variability of tongue protrusion forces, grip force, and tapping may provide objective and quantitative measures that (1) provides much needed empirical data on the motor symptoms of AD and help elucidate a motor pattern, and (2) correlates with illness severity (thus may be a measure of disease progression). This knowledge, in addition to improvements in the efficiency and precision of objective measurements of disease progression in individuals with AD, could lead to techniques that are better able to assess disease progression and measure effectiveness of therapeutic interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32331 0
Address 32331 0
Country 32331 0
Phone 32331 0
Fax 32331 0
Email 32331 0
Contact person for public queries
Name 15578 0
Dr Anita Goh
Address 15578 0
AUPOA
Normanby Unit
283 Cotham Rd
Kew
Victoria 3101
Country 15578 0
Australia
Phone 15578 0
+61 3 9816 0513
Fax 15578 0
Email 15578 0
[email protected]
Contact person for scientific queries
Name 6506 0
Dr Anita Goh
Address 6506 0
AUPOA
Normanby Unit
283 Cotham Rd
Kew
Victoria 3101
Country 6506 0
Australia
Phone 6506 0
+61 3 9816 0513
Fax 6506 0
Email 6506 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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