NCT05411653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2023

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

June 6, 2022

Last Update Submit

January 28, 2024

Conditions

Keywords

Stroke

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Barthel index

    6th week

Study Arms (2)

Virtual reality training with motor imagery

EXPERIMENTAL

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

Conventional physical therapy

ACTIVE COMPARATOR

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

Other: Conventional physical therapy

Interventions

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.

Virtual reality training with motor imagery

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

Conventional physical therapy

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (14)

  • Lee HC, Huang CL, Ho SH, Sung WH. The Effect of a Virtual Reality Game Intervention on Balance for Patients with Stroke: A Randomized Controlled Trial. Games Health J. 2017 Oct;6(5):303-311. doi: 10.1089/g4h.2016.0109. Epub 2017 Aug 3.

    PMID: 28771379BACKGROUND
  • Aslam M, Ain QU, Fayyaz P, Malik AN. Exer-gaming reduces fall risk and improves mobility after stroke. J Pak Med Assoc. 2021 Jun;71(6):1673-1675. doi: 10.47391/JPMA.875.

    PMID: 34111095BACKGROUND
  • 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.

    PMID: 25206611BACKGROUND
  • Silva S, Borges LR, Santiago L, Lucena L, Lindquist AR, Ribeiro T. Motor imagery for gait rehabilitation after stroke. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD013019. doi: 10.1002/14651858.CD013019.pub2.

    PMID: 32970328BACKGROUND
  • Bovonsunthonchai S, Aung N, Hiengkaew V, Tretriluxana J. A randomized controlled trial of motor imagery combined with structured progressive circuit class therapy on gait in stroke survivors. Sci Rep. 2020 Apr 24;10(1):6945. doi: 10.1038/s41598-020-63914-8.

    PMID: 32332810BACKGROUND
  • Lin RC, Chiang SL, Heitkemper MM, Weng SM, Lin CF, Yang FC, Lin CH. Effectiveness of Early Rehabilitation Combined With Virtual Reality Training on Muscle Strength, Mood State, and Functional Status in Patients With Acute Stroke: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2020 Apr;17(2):158-167. doi: 10.1111/wvn.12429. Epub 2020 Mar 25.

    PMID: 32212254BACKGROUND
  • Askin A, Atar E, Kocyigit H, Tosun A. Effects of Kinect-based virtual reality game training on upper extremity motor recovery in chronic stroke. Somatosens Mot Res. 2018 Mar;35(1):25-32. doi: 10.1080/08990220.2018.1444599. Epub 2018 Mar 13.

    PMID: 29529919BACKGROUND
  • Malik AN, Masood T. Effects of virtual reality training on mobility and physical function in stroke. J Pak Med Assoc. 2017 Oct;67(10):1618-1620.

    PMID: 28955088BACKGROUND
  • Chanpimol S, Seamon B, Hernandez H, Harris-Love M, Blackman MR. Using Xbox kinect motion capture technology to improve clinical rehabilitation outcomes for balance and cardiovascular health in an individual with chronic TBI. Arch Physiother. 2017;7:6. doi: 10.1186/s40945-017-0033-9. Epub 2017 May 31.

    PMID: 28824816BACKGROUND
  • In T, Lee K, Song C. Virtual Reality Reflection Therapy Improves Balance and Gait in Patients with Chronic Stroke: Randomized Controlled Trials. Med Sci Monit. 2016 Oct 28;22:4046-4053. doi: 10.12659/msm.898157.

    PMID: 27791207BACKGROUND
  • Im H, Ku J, Kim HJ, Kang YJ. Virtual Reality-Guided Motor Imagery Increases Corticomotor Excitability in Healthy Volunteers and Stroke Patients. Ann Rehabil Med. 2016 Jun;40(3):420-31. doi: 10.5535/arm.2016.40.3.420. Epub 2016 Jun 29.

    PMID: 27446778BACKGROUND
  • Gibbons EM, Thomson AN, de Noronha M, Joseph S. Are virtual reality technologies effective in improving lower limb outcomes for patients following stroke - a systematic review with meta-analysis. Top Stroke Rehabil. 2016 Dec;23(6):440-457. doi: 10.1080/10749357.2016.1183349. Epub 2016 May 30.

    PMID: 27237336BACKGROUND
  • Bae YH, Ko Y, Ha H, Ahn SY, Lee W, Lee SM. An efficacy study on improving balance and gait in subacute stroke patients by balance training with additional motor imagery: a pilot study. J Phys Ther Sci. 2015 Oct;27(10):3245-8. doi: 10.1589/jpts.27.3245. Epub 2015 Oct 30.

    PMID: 26644684BACKGROUND
  • Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.

    PMID: 28606661BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    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
SPONSOR

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 9, 2022

Study Start

March 4, 2022

Primary Completion

January 24, 2023

Study Completion

February 24, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations