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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Virtual reality training with motor imagery
Conventional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Services Hospital LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality training with motor imagery

Conventional physical therapy

Arm Description

Xbox Kinect VR with MI training Five Xbox Kinect gaming will be selected and explained to the patients for the virtual training session

a range of motion exercises, muscle strengthening, functional training, balance training, and gait training. T

Outcomes

Primary Outcome Measures

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
Berg Balance Scale BBS
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
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.
Six Minute Walk Test
It is used to assess aerobic capacity and endurance.

Secondary Outcome Measures

Barthel index
It is functional independence measure.

Full Information

First Posted
June 6, 2022
Last Updated
January 4, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05411653
Brief Title
Xbox Kinect Virtual Reality and Motor Imagery on Lower Limb Function in Chronic Stroke Patients
Official Title
Combined Effects of Xbox Kinect Virtual Reality and Motor Imagery on Lower Limb Function, Dynamic Balance and Gait in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
January 24, 2023 (Anticipated)
Study Completion Date
January 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality training with motor imagery
Arm Type
Experimental
Arm Description
Xbox Kinect VR with MI training Five Xbox Kinect gaming will be selected and explained to the patients for the virtual training session
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
a range of motion exercises, muscle strengthening, functional training, balance training, and gait training. T
Intervention Type
Other
Intervention Name(s)
Virtual reality training with motor imagery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Dynamic Gait Index DGI
Description
Clinical tool to assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks
Time Frame
6th week
Title
Berg Balance Scale BBS
Description
Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Time Frame
6th week
Title
Fugl-Meyer Scale for lower extremity
Description
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.
Time Frame
6th week
Title
Six Minute Walk Test
Description
It is used to assess aerobic capacity and endurance.
Time Frame
6th week
Secondary Outcome Measure Information:
Title
Barthel index
Description
It is functional independence measure.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, phD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, PHD*
Organizational Affiliation
Riphah international university lahore campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Services Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baseerat Iqbal, Ms NMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28771379
Citation
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Results Reference
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Citation
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Results Reference
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25206611
Citation
Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
Results Reference
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Citation
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Citation
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Xbox Kinect Virtual Reality and Motor Imagery on Lower Limb Function in Chronic Stroke Patients

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