Clinical trial NCT04036422: Effects of a Computerised Exercise System on Functionality of the Arm,Cognition and Quality of Life in Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Neuronal Plasticity
Hemiplegia
Keywords: stroke
neuronal plasticity
cognition
hemiplegia
Remote rehabilitation
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomized into one of two groups (fifteen patients in each group) using the Random Allocation Software. All patients will receive a one hourly 'one-on-one' session of physiotherapy five days a week to a total of twenty hours (four weeks) which includes strengthening, balance and walking exercises. In addition to this, one group will receive half and hour of conventional occupational therapy which includes task based exercises aimed at improving upper arm dexterity, coordination and strength seven days a week to a total of twenty eight hours (four weeks), whereas patients in the other group will receive half an hour of Rejoyce computerized exercise to a total of twenty eight hours (four weeks).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In developed countries only 5-10% of chronic stroke patients receive an active rehabilitation program. In Turkey, there is no community based rehabilitation program available to stroke patients in the subacute - chronic phase of the disease, even though it is known that functional gain can continue in this part of the disease when supported by an adequate rehabilitation program. Equally, functional gain can be lost over time if appropriate physical therapy is discontinued.

Recent Advances in technology have allowed for the development of new approaches in stroke rehabilitation. Computer based treatment options include virtual reality (VR), robotic training and computer based task specific games. Computer based rehabilitation can encourage patients in performing high intensity, repetitive exercises which in turn aids neuroplasticity; the benefits of such treatments in upper extremity rehabilitation following stroke have been established. It is also believed that the stimulating environment provided by computed based exercises can enhance the development of problem solving and functionality in stroke patients. However, the effects of such technology on cognitive function in stroke patients has not been established in the literature. The disadvantages of VR and robotic training is that the necessary hard and software is often expensive and use of the machinery requires special training. Therefore, these options are often unavailable in rehabilitation centres. Contrary to this, computerized task specific gaming systems can be more economical and practical for both therapist and patient and can be used in the home environment without the necessity of direct supervision of a physiatrist.

A review by Johansson et al. on home computer based task specific gaming exercises in stroke patients concluded that patients enjoyed the treatment but determining the benefits of treatment require further randomized control studies of better quality to be conducted. A pilot study based on a six week computer based task specific gaming exercise program in chronic stroke patients resulted in an improvement in learnt tasks and clinical evaluation.

Rejoyce (Rehabilitation Joystick for Computerized Exercise), is a computer game based task specific exercise system developed by Rehabtronics Inc. for use as part of the treatment of stroke and spinal cord injury patients. Rejoyce aims to improve upper extremity and hand function by encouraging neuroplasticity through repeated task specific games.

The aim of this study was to study the effects of computer game based task specific exercise system on upper extremity and hand function as well as cognitive function and quality of life compared to conventional rehabilitation in stroke patients.

Patients who have developed a stroke in the past year and who have been admitted to our Physical and Rehabilitation Medicine (PRM) Department in Turkey for stroke rehabilitation will be included in the study. The total number of patients to be included in the study to obtain a study power of 80% and 5% type I error is thirty.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in upper extremity impairment
timeFrame: 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 outcomes:
measure: Change in motor activity
timeFrame: 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).
measure: Mini mental state examination (MMSE)
timeFrame: 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).
measure: Montreal Cognitive Assessment (MoCA) test
timeFrame: 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).
measure: Stroke Specific Quality of Life (SS-QOL) Scale
timeFrame: 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).
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Faculty of Medicine, Ankara Hospital
Study officials:
affiliation: Baskent University Faculty of Medicine
name: Selin Ozen, MBBS,BSc
role: PRINCIPAL_INVESTIGATOR
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