Clinical trial NCT02759328: Xbox Kinect™ Training for Stroke Rehabilitation
Official title: Clinical Feasibility of the Xbox Kinect™ Training for Stroke Rehabilitation: a Single Blind Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Serious games
Virtual reality
Xbox Kinect™
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Commercial interactive game consoles including the Nintendo Wii™ and the Sony Playstation Eyetoy™ have been used in stroke rehabilitation with variable success and seemed to be safe, feasible and effective treatment options. The more recently released Xbox Kinect™ game console has superiorities to the others such as not requiring any special controller and having a more sensitive sensor which provides more accurate motion-capturing. However, there is limited evidence on clinical utility of the Xbox Kinect™ in stroke rehabilitation. Currently it has been designed for physically and mentally healthy people just like previous consoles. Therefore, the safety and feasibility of the system should be evaluated in first place before using it as an alternative or adjunctive training method in stroke patients. To the best of our knowledge, no studies have evaluated the clinical feasibility of the Xbox Kinect™ in stroke rehabilitation. The aim of this pilot study was to evaluate the feasibility and safety of the Xbox Kinect™ training of upper extremity in subacute stroke rehabilitation. The secondary aim was to evaluate its efficacy on upper extremity motor and functional recovery.

Detailed description: This study was planned as a single-blind, randomized controlled, pilot trial. It was approved by the Ankara University Faculty of Medicine Ethics Committee and was conducted in accordance with the Declaration of Helsinki. Stroke patients who were hospitalized for inpatient rehabilitation at the Ankara University Faculty of Medicine, Cebeci Research and Application Hospital, Physical Medicine and Rehabilitation Clinic from December 2012 to March 2014, were assessed to determine their eligibility for the study. All patients were diagnosed with stroke by a neurologist according to World Health Organization stroke definition and confirmed by neuroimaging (computed tomography or magnetic resonance imaging). All patients who fulfilled the inclusion criteria received a detailed explanation of the study and written informed consent was obtained from all participants prior to enrollment. Patient characteristics were collected at baseline including socio-demographic features (age, gender, marital status, educational level, vocation), stroke type, time from stroke onset to enrollment, affected side, handedness, comorbid conditions, spasticity grade (according to Modified Ashworth Scale) and motor recovery stages according to Brunnstrom Motor Assessment Scale (BMAS). Affected upper extremity was examined using the Box and Blocks Test (BBT) and the Wolf Motor Function Test (WMFT). Baseline level of functional independence was assessed using the Functional Independence Measure (FIM). Participants were randomly allocated to two groups; the experimental group and the control group. Both the experimental group and the control group received a conventional rehabilitation program for 4 weeks (60 minutes/day, 5 days/week). The experimental group underwent an additional training with the Xbox Kinect™ for 4 weeks (60 minutes/day, 5 days/week). The primary outcome measures of this pilot study are related to feasibility and safety of the Xbox Kinect™ in subacute stroke rehabilitation. Treatment attendance ratio, which is the proportion of the completed training time to the planned training time, was used as the primary feasibility outcome. The treatment attendance ratios were calculated for three different measurements: total training time, training time per session and the number of sessions. In addition, the result obtained from patient feedback survey was also used as a feasibility outcome. The ratio of patients who had adverse events related to the intervention or any serious adverse event during the study was defined as the primary safety outcome. Rating of perceived exertion measured according to the Borg 10 Point Scale was also used as a safety outcome. To determine the efficacy of the intervention, BBT, WMFT, FIM, BMAS were used as secondary outcome measures. Mean, standard deviation, median, min-max and percentile values were calculated for the socio-demographic and clinical features, primary and secondary outcome measures by descriptive statistics. The Shapiro-Wilk test was used for normality testing. The Wilcoxon signed rank test was used to evaluate differences within groups. The Mann Whitney U test was used to evaluate differences between groups. P value of less than .05 was considered as statistically significant.

Eligibility criteria: Inclusion Criteria:

* First-time ischemic or hemorrhagic stroke occurring in the last 9 months
* Between 18 and 80 years of age
* Brunnstrom motor recovery stage in the affected upper extremity ≥ 3
* Ability to understand and follow simple explanations and commands
* Mini-Mental State Examination score of ≥ 24

Exclusion Criteria:

* History of epilepsy or seizure (except childhood febrile seizures)
* Arthritis or pain restricting the repetitive training of the affected upper extremity
* Severe aphasia
* Neglect phenomena
* Cognitive or psychiatric disorders
* ≥ Grade 3 spasticity in the affected upper extremity according to Modified Ashworth Scale
* Medical conditions which may affect physical performance or the physical activity may become unsafe (unstable angina, myocardial infarction within the last 3 months, uncontrolled blood pressure, pulmonary disease, etc.)
* Participation in another clinical trial

Primary outcomes:
measure: Treatment attendance ratios
timeFrame: Every training session during 4 weeks (total 20 sessions)
measure: Number of patients with adverse events
timeFrame: Every training session during 4 weeks (total 20 sessions)
Secondary outcomes:
measure: Box and Blocks Test
timeFrame: Change from baseline at 4 weeks
measure: Wolf Motor Function Test
timeFrame: Change from baseline at 4 weeks
measure: Functional Independence Measure
timeFrame: Change from baseline at 4 weeks
measure: Brunnstrom Motor Assessment Scale
timeFrame: Change from baseline at 4 weeks
measure: Patient feedback survey
timeFrame: At 4 weeks (after completion of all treatment sessions (total 20 sessions))
measure: Borg 10 Point Scale
timeFrame: Every training session during 4 weeks (total 20 sessions)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, Cebeci Research and Application Hospital
Study officials:
affiliation: Ankara University
name: Haydar GOK, Professor
role: PRINCIPAL_INVESTIGATOR
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