Xbox Kinect Virtual Reality and Motor Imagery on Lower Limb Function in Chronic Stroke Patients

Study Overview
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Brief Summary
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As virtual reality has therapeutic benefits and improves motor learning by practicing exercises in environment that analogue and mimic occasions and events of real world, as VR is designed and tailored according to the need of patient so it may address the individual issues whereas motor imagery uses explicit learning process for muscle activation and movement. Therefore their combination may yield better outcomes in terms of lower limb function and dynamic mobility, so there is a need to assess the combined effects of Xbox kinect gaming with motor imagery in chronic stroke patients.

Detailed Description
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Stroke is focal neurological disorder that occurs due to the compromised blood flow to the brain. It results in mobility deficit, functional and gait impairment. Multiple rehabilitation methods have been designed and used, motor imagery (MI) and virtual reality (VR) are among the emerging techniques that are being used for the rehabilitation of patients with neurological conditions that improve motor learning through explicit and implicit processes. After stroke the residual symptoms such as muscle hyper tonicity, attention deficiency, hemi neglect, abnormal reflexes and sensorimotor functional impairment may persist. Additional to these neurological symptoms certain balance issues may cause decrease in proprioception, muscle strength, increased load on non-paretic extremity and postural oscillations. It has been reported that every year approximately 25.7 million people survive stroke attacks, 6.5 million die because of stroke and 113 million people have disability-adjusted life-years. Kinect based rehabilitation and virtual feedback have shown relevant activation changes in the primary sensorimotor cortex and can be responsible for that part of brain reorganization for improving in upper limb in stroke patients. Use of exer gaming is one of the emerging technologies that are being used for the physical, cognitive and motor rehabilitation of stroke patients. It is combination of video games and motion sensors incorporated in a virtual reality environment that engage the patients and improves motor learning therefore activating the motor areas of the brain for long term results. Non immersive virtual reality gaming has been used for improving balance among the stroke patients. Not only is it considered more beneficial as compared to the conventional therapies but also maintains the interest of patients in their rehabilitation protocol. The Kinect based games use sensors that catch movements of the patients and they are able to watch them in real time with immediate feedback that becomes a source of motivation for them. Xbox Kinect virtual gaming creates 3D environment with sensors and requires no controllers for patients to perform exercise whereas motor imagery is a state in which a particular motor action is internally activated without any motor output. Not only is VR and MI training motivating as compare to conventional therapies but also provide positive learning experience and neuroplasticity. With xbox kinect based VR therapies and MI, the exercise plan is tailored according to the needs of the patient. It will be a single blinded randomized control trial in which control group will be given conventional physiotherapy protocol for 30 minutes and experimental group will receive the VR and MI training with conventional treatment for a total 60 minutes, 3 days a week for 6 weeks. Motor function will be assessed by fugl-meyer scale (LE), dynamic mobility by berg balance scale and 6 minute walk test, quality of life by barthel index and gait with dynamic gait index. Patient will be assessed at baseline and at the end of six weeks. The data will be analyzed using SPSS 25 software.

Official Title
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Combined Effects of Xbox Kinect Virtual Reality and Motor Imagery on Lower Limb Function, Dynamic Balance and Gait in Chronic Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Other: Virtual reality training with motor imagery
* Other: Conventional physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are 45-65 years of age Participants who have had their first stroke attack at least 6 months prior A score of 21 or greater on the Mini-Mental State Examination (MMSE) Participants who were not diagnosed with visual or auditory issues Volunteers should be able to walk at least 10 meters with or without assistive devices The patient shouldn't be taking any medicine that can have an impact on the gait or balance. Exclusion Criteria: Patients younger than 45 years of age. Patients suffering from any condition that requires medical attention such as uncontrolled blood pressure or angina. Musculoskeletal impairments of the lower extremity. Patients with psychological or neurological problems other than stroke

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality training with motor imagery<br>Xbox Kinect VR with MI training Five Xbox Kinect gaming will be selected and explained to the patients for the virtual training session | Other: Virtual reality training with motor imagery<br>* comprised of 30 minutes, VRT (15 minutes) and MI (15 minutes) daily for 3 days respectively. Five Xbox Kinect gaming will be selected and explained to the patients for the virtual training session and additional 15 minutes will be given to them for practice. The games consists of 20,000 water leaks, river rush, reflex ridge, soccer and football for the patients.<br>|
| Active Comparator: Conventional physical therapy<br>a range of motion exercises, muscle strengthening, functional training, balance training, and gait training. T | Other: Conventional physical therapy<br>* range of motion exercises, muscle strengthening, functional training, balance training, and gait training. The specific tasks will be selected by the therapist based on the requirement of each patient. It will be performed for 30 minutes for 3 days a week for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Gait Index DGI | Clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks | 6th week | 
| Berg Balance Scale BBS | Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. | 6th week | 
| Fugl-Meyer Scale for lower extremity | This clinical tool is for assessment of lower limb function. It is a reliable and valid tool. Interrater and intrarater reliability coefficients are reported to be >0.85 for both upper and lower limb) the domain subscales and the entire scale. | 6th week | 
| Six Minute Walk Test | It is used to assess aerobic capacity and endurance. | 6th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index | It is functional independence measure. | 6th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke