Stroke Clinical Trial
Official title:
The Effects of a Task Based Computerised Exercise System Versus Conventional Physiotherapy on Upper Extremity Functionality, Cognitive Function and Quality of Life in the Rehabilitation of Stroke Patients: a Randomised Control Study
Verified date | May 2021 |
Source | Baskent University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stroke occurs as a result of blood vessels of the brain becoming blocked or bleeding which in turn can result in loss of function in the limbs. Rehabilitation of patients following stroke includes repetitive, task based exercises to help regain normal limb function. Developments in stroke rehabilitation have resulted in more and more therapeutic options being available for inclusion in the treatment plan of stroke patients. The benefits of computerised task based arm and hand rehabilitation exercises in stroke rehabilitation are well known. Computer based rehabilitation supports the stroke patient in performing high intensity, multiple repetition exercises and in doing so encourages the regeneration of brain cells. In addition, it is believed that the stimulating environment provided by computerised exercise programs encourages the ability to problem solve and perform tasks. However, the effects of such computer based treatments on cognition have rarely been studied. In Turkey to date there are no community based, task specific computerised exercise programmes available to stroke sufferers. Such systems may provide inpatient and community based stroke sufferers with a practical and economical therapeutic option as a part of stroke rehabilitation. Moreover, this may provide the patient with a mode of ongoing, long term therapeutic exercise and maintenance of skills acquired in the hospital rehabilitation period shortly after stroke. The aim of this study was to investigate the benefits of computer based, task specific exercises when compared to conventional rehabilitation alone on arm and hand function, quality of life and cognition in stroke patients.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 15, 2020 |
Est. primary completion date | November 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Between the ages of 18-80 years - Admitted to our PRM Department with a diagnosis of hemiplegia secondary to stroke for rehabilitation - Upper extremity and hand Brunnstrom staging of =3. - MMSE score of =23. Exclusion Criteria: - Presence of disability of the arms and hand which affects upper extremity motor function prior to stroke - Presence of diplegia - Presence of neglect - Presence of visual field defect - Presence of loss of hearing - Presence of spasticity in the hemiplegic upper extremity and hand of grade 3 and above according to the Modified Ashworth Scale - Presence of acute musculoskeletal pain which will affect exercise participation - Inability to sit upright in a chair for 30 minutes. - Those who are clinically unstable due to comorbidities. |
Country | Name | City | State |
---|---|---|---|
Turkey | Baskent University Faculty of Medicine, Ankara Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Baskent University |
Turkey,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in upper extremity impairment | The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It has been extensively used as an outcome measure in rehabilitation trials and to record poststroke recovery, particularly in the USA.
The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. It is free, requires only household items for testing, and takes up to 30 minutes to administer.The total score ranges from 0-66 where 66. The higher the score the less the level of impairment. |
Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment). | |
Secondary | Change in motor activity | The Brunnstrom Stages of Stroke Recovery is a test that evaluates the motor development of stroke patients. In 1966, Signe Brunnstrom identified the stages of motor development observed in a large number of hemiplegic patients. In this staging, the hemiplegic upper extremity, lower extremity and hand are evaluated separately and the motor development of these three areas are staged from 1-6. The lowest stage according to this staging system is stage 1 (flask, no movement); the highest stage is stage 6 (normal motor function). Higher Brunnstrom stages indicate better motor development. | Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment). | |
Secondary | Mini mental state examination (MMSE) | The MMS is a test used to evaluate cognitive function which consists of eleven questions. The maximum score which can be obtained is thirty. The cut off score for normal cognitive function is 23. The MMS is divided into two sections, the first of which requires vocal responses only and covers orientation, memory, and attention; the maximum score is 21. The second part tests ability to name, follow verbal and written commands, write a sentence spontaneously, and copy a complex polygon similar to a Bender-Gestalt Figure; the maximum score is nine. The validity and reliability of the Turkish version of the MMS has been studied and proven | Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment). | |
Secondary | Montreal Cognitive Assessment (MoCA) test | The MoCA is used to assess and detect mild cognitive impairment and has been shown to be a reliable tool in the assessment of cognitive function following acute onset of stroke. The MoCA is a thirty point test with a cut off for 'normal' cognition of 21. The MoCA consists of a series of questions aimed at evaluating short-term memory recall, visuospatial abilities, executive functions, attention, concentration, and working memory and language. | Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment). | |
Secondary | Stroke Specific Quality of Life (SS-QOL) Scale | The SS-QOL is a questionnaire used to evaluate a stroke patient's independence in activities of daily living, social role within the family and community and quality of life (QOL). The SS-QOL consists of 49 questions which are each given a score between 1 and 5 giving a total score between 49 and 245. The higher the total score the better the patient's QOL. The validity and reliability of the Turkish version of the SS-QOL has been studied. | Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment). |
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