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Clinical Trial Summary

The purpose of this study is to verify the efficacy of speed-feedback therapy in improving the cognitive function of elderly people with dementia by a randomized controlled trial, and to demonstrate how that affects ADL and QOL.


Clinical Trial Description

Dementia is a syndrome caused by diseases of the cerebral parenchyma, and it is a state in which cognitive functions, including attention, memory, thinking, comprehension, judgment, and computation, are diminished. Because of the mental symptoms, problem behaviors, and decreased activities of daily living (ADL) it is also recognized as a major social problem. However, rehabilitation of elderly people with dementia is still at the trial-and-error stage, and establishing a method of rehabilitation is an urgent task. In 2004, the authors devised and created a training method that integrates exercise therapy with feedback therapy to treat the cognitive dysfunction of elderly people with dementia. To do so the authors introduced speed-feedback therapy with a bicycle ergometer as a feedback therapy intervention. The results of a preliminary study of the efficacy of this method in improving cognitive dysfunction in 17 elderly persons with dementia showed improvement in cognitive dysfunction, and their attentiveness also improved, suggesting that the impaired attentiveness may have improved in response to treatment by this method and, as a result, have led to improvement of cognitive dysfunction. However, it became clear that it would be necessary to further improve and develop the system, and to demonstrate its efficacy in a controlled trial and verify associations between improvement of cognitive dysfunction and improvement of the ADL of dementia patients and their quality of life (QOL). ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00450047
Study type Interventional
Source Hiroshima University
Contact
Status Completed
Phase Phase 4
Start date September 2005
Completion date December 2006

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