Xbox Kinect™ Training for Stroke Rehabilitation

NCT02759328 | Completed

• 1 other identifier: 20-645-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; Serious games; Virtual reality; Xbox Kinect™

Outcome Measures

Primary Outcomes (2)

• Treatment attendance ratios

  A feasibility outcome. The proportion of the completed training time to the planned training time.

  Every training session during 4 weeks (total 20 sessions)

• Number of patients with adverse events

  A safety outcome.

  Every training session during 4 weeks (total 20 sessions)

Secondary Outcomes (6)

• Box and Blocks Test

  Change from baseline at 4 weeks

• Wolf Motor Function Test

  Change from baseline at 4 weeks

• Functional Independence Measure

  Change from baseline at 4 weeks

• Brunnstrom Motor Assessment Scale

  Change from baseline at 4 weeks

• Patient feedback survey

  At 4 weeks (after completion of all treatment sessions (total 20 sessions))

Study Arms (2)

Xbox Kinect™ training group

EXPERIMENTAL

60 minutes/day, 5 days/week, 4 weeks (20 sessions) conventional rehabilitation program plus 60 minutes/day, 5 days/week, 4 weeks (20 sessions) Xbox Kinect™ upper extremity training. Two games both of which require using upper extremities, were chosen and each game was played for 30 minutes per session.

Behavioral: Xbox Kinect™ training

Conventional rehabilitation group

ACTIVE COMPARATOR

60 minutes/day, 5 days/week, 4 weeks (20 sessions) conventional rehabilitation program only. The treatment protocol was individualized according to the goals which were determined depending on each patient's needs and functional level.

Behavioral: Conventional rehabilitation

Interventions

Xbox Kinect™ training BEHAVIORAL

Xbox Kinect™ (Xbox 360, Microsoft, United States) game console which is one of the commercial interactive game consoles was used. It was comprised of 3 components; Kinect™ sensor, Xbox 360™ game console and 42 inch Liquid crystal display (LCD) television.

Xbox Kinect™ training group

Conventional rehabilitation BEHAVIORAL

The conventional rehabilitation program consisted of passive and active range of motion exercises, therapeutic stretching, muscle strengthening, neurophysiologic exercises, sitting, standing, balance and gait exercises, occupational therapy and activities of daily living training such as eating, grooming, dressing, toileting and transfer.

Conventional rehabilitation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine, Cebeci Research and Application Hospital

Ankara, Ankara, 06620, Turkey (Türkiye)

Location

Related Publications (28)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Haydar GOK, Professor

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 3, 2016
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 3, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)