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Clinical Trials/NCT05232526
NCT05232526
Recruiting
Not Applicable

The Effectiveness of Mental Imagery in Motor and Cognitive Rehabilitation in Subjects of Early Stage of Dementia

University of West Attica1 site in 1 country105 target enrollmentOctober 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Imagery
Sponsor
University of West Attica
Enrollment
105
Locations
1
Primary Endpoint
Change is being assessed (Change from Baseline Balance at 12 weeks)
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

The purpose of the present study is to investigate the effectiveness of mental imagery (MI) in subjects with early stage of dementia. The hypothesis of the study is that MI will have a beneficial effect in motor, cognitive and emotional state in this clinical population.

Detailed Description

Dementia is a disorder that is characterized by a decline in cognition involving one or more cognitive domains (learning and memory, language, executive function, complex attention, perceptual-motor, social cognition). The most common form of dementia in older adults is Alzheimer disease (AD), accounting for 60 to 80 percent of cases. Mental imagery (MI) is a technique which involves envisioning motor actions without actual execution. MI is considered an effective rehabilitative tool in athletes, Parkinson's disease, and post stroke because it engages the same or similar neural systems as the actual execution of motor actions to improve gait, gait-related, and cognitive functions having as a result improvements in gait speed, stride length, tandem stance, timed up and go, clock drawing and stroop interference. The recruitment of the population will be carried out by Day Care Centers in Athens Alzheimer Association. A group of elderly patients with early stage of dementia, aged 65 to 95 years, will participate. Information sheet and consent form will be provided to all participants. A randomized intervention study is designed to assess the efficacy of MI as therapeutic strategy for subjects with early stage of dementia and the sample will be randomized to one of the three following study groups: 1. MI and exercise program (intervention group) 2. Only exercise program (control group) 3. Neither MI nor exercise program (2nd control group). Assessment will be obtained in three-time periods: prior to the program, middle of the program and after the program.

Registry
clinicaltrials.gov
Start Date
October 10, 2021
End Date
October 10, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anna Christakou

Principal Investigator

University of West Attica

Eligibility Criteria

Inclusion Criteria

  • 95 years\<age\>65 years
  • Diagnosed early stage of dementia
  • Good oral and written speech and to perform orders
  • Both sexes
  • Ambulatory
  • No other health issues in the last month

Exclusion Criteria

  • Late stage of dementia
  • Psychiatric problems
  • Serious health problems
  • Not able to walk

Outcomes

Primary Outcomes

Change is being assessed (Change from Baseline Balance at 12 weeks)

Time Frame: Prior to the 1st week of the program, the 12th week of the program

The Berg Balance Scale (BBS) is used to objectively determine a subject's ability to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a 5-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.

Change is being assessed (Change from Baseline Functional status at 12 weeks)

Time Frame: Prior to the 1st week of the program, the 12th week of the program

The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility. It measures the time that a subject takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.

Change is being assessed (Change from Baseline Stability at 12 weeks)

Time Frame: Prior to the 1st week of the program, the 12th week of the program

The Multidirectional Reach Test (Reach in Four Directions Test) is a screening tool to determine the limits of stability of subjects in 4 directions: forward, backward, leftward and rightward. Subjects performed maximal outstretched arm reach in each direction with their feet flat on the floor.

Change is being assessed (Change from Baseline Siti-to-stand ability at 12weeks)

Time Frame: Prior to the 1st week of the program, the 12th week of the program

The Five Times Sit-to-Stand Test (FTSST) is considered to be a useful, consistent and low-cost tool to assess sit-to-stand ability. The FTSST measures the time taken to stand five times from a sitting position as quickly as possible that measures of lower limb strength, balance control and exercise capacity.

Secondary Outcomes

  • Cognitive ability(Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program)
  • Depression(Prior to the 1st week of the program, the 6th week of the program, the 12th week of the program)
  • Quality of life(Prior to the 6th week of the program, the 6th week of the program, the 12th week of the program)

Study Sites (1)

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