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StrokeNCT06308341

Combined Effects of Virtual Reality and Motor Imagery Techniques With Routine Physical Therapy in Post Stroke Patients

A study testing Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy, Virtual Reality + Routine Physical Therapy and Motor Imagery +Routine Physical Therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke a devastating neurological condition, causing severe neurological challenges such as balance issues, motor function and cognitive deficits among survivors and can cause disability and death. The use of Virtual Reality and Motor Imagery in rehabilitation of neurologic disorders is on the rise. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Stroke
What is being tested?
Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy, Virtual Reality + Routine Physical Therapy and Motor Imagery +Routine Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 sitePakistan
Study dates
25 Feb 2024to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of stroke of any etiology
  • Age between 40 to 65 years
  • Both genders
  • At least 6 months post-stroke onset
  • Able to follow and understand visual and verbal commands.
  • Hemiparetic
Show all 9Show fewer
  • No prior experience with VR-based rehabilitation.
  • Able to walk with the use of walking aids or assistive devices.
  • Mini-Mental State Examination (MMSE) score equal to or greater than 24

Who cannot join

  • Presence of aphasia, apraxia, and hemineglect
  • Serious cardiovascular disease (heart failure, arrhythmias, angina pectoris or myocardial infarction)
  • Cerebellar lesion
  • Multiple brain accidents
  • Muscular disorder effect upper and lower extremities
  • History of seizures or epilepsy.
Show all 10Show fewer
  • Patients whose injury occurred fewer than 6 months previously, considering the expected time for spontaneous recovery;
  • Patients with associated disorders such as epilepsy, and sensory and perceptual deficits such as hemineglect and Pusher syndrome;
  • Patients with osteo degenerative disorders that would prevent participation in the games or that could influence the body balance; and individuals who had cognitive and communication disorders, affecting understanding, that could compromise performance in the games
  • Inability to commit to the study schedule or attend the required therapy sessions

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Riphah International University

    Lahore, Punjab Province, 54660

Other trials in Pakistan

About this study

Official title: Combined Effects of Virtual Reality and Motor Imagery Techniques With Routine Physical Therapy on Balance, Motor Function and Activities of Daily Living in Post Stroke Patients

Stroke a devastating neurological condition, causing severe neurological challenges such as balance issues, motor function and cognitive deficits among survivors and can cause disability and death. The use of Virtual Reality and Motor Imagery in rehabilitation of neurologic disorders is on the rise. In stroke patients, VR and MI combination has not been studied. This study aims to investigate the combined effects of Virtual Reality and Motor Imagery Techniques with Routine Physical Therapy in patients with post stroke patients.

Read the detailed description

This randomized control trial will be conducted at Safi Hospital Faisalabad in 7 months after the approval of synopsis, involving a sample size of 75 participants selected through convenience sampling based on the inclusion criteria. Participants will be randomly assigned to three groups using lottery method, in which Group A, will receive Virtual Reality and Motor Imagery training in conjunction with routine physical therapy three days a week for 12 weeks. Group B will receive VR and routine physical therapy, supplemented by 10-15 minutes of cycling and walking and Group C will receive routine physical therapy with MI techniques, along with 10-15 minutes of cycling and walking.

Fugal-Meyer Scale will be used to motor function, Berg Balance Scale for balance and Barthel Index will be used to assess activities of daily living. Assessment will be carried out at baseline, 6th week, 8th week and at 12th week and at 16th week after the discontinuation of treatment. The data will be entered and analyzed by using SPSS 26

Conditions
Stroke
Being tested
Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy, Virtual Reality + Routine Physical Therapy, Motor Imagery +Routine Physical Therapy
Keywords
Activities of Daily Living, Stroke, Motor Control, Randomized Clinical Trial
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality technique + Motor Imagery technique + Routine Physical TherapyOther

    Routine physical therapy for 30 minutes is explained as: warm up for 10 mins, stretching of lower limb and upper limb for 10 min, task specific training, gait training and balance training exercises for 15min, strengthening exercises for 10 min

  • Virtual Reality + Routine Physical TherapyOther

    Routine physical therapy protocol will be given for 30 minutes along with cycling and walking for 10-15 minutes.

    VR techniques for 10-15 minutes The first eight weeks focus on simple activities to enhance balance and motor function, such as tennis, boxing, bowling, kicking, soccer, table tilt, penguin slide, tilt city, single-leg extension, and torso twist. Exercise difficulty is adjusted based on performance, gradually progressing from easier to more challenging activities.

  • Motor Imagery +Routine Physical TherapyOther

    Routine physical therapy protocol will be given for 30 minutes along with Cycling and walking for 10-15 minutes MI techniques for 10-15 minutes The motor imagery program me will be performed in three steps; STEP I: The patients will watch the videos recorded by the examiner. STEP II: The patients will be asked to close their eyes, focus, and imagine how they are doing the task they had previously observed ten times.

    Step III: The patient will be asked to attempt the activity with his affected limbs according to the verbal command of the examiner Routine physical therapy for 30 minutes is explained as: warm up for 10 mins, stretching of lower limb and upper limb for 10 min, task specific training, gait training and balance training exercises for 15min, strengthening exercises for 10 min.

Study groups in NCT06308341
Study groupRoleWhat they receive
Group A: (Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy)OtherParticipants in this group will receive Virtual Reality (VR) for and Motor Imagery (MI) training with routine physical therapy for every alternate day (3 days per week) for 12 weeks. Total 45 minutes of session. Routine physical therapy protocol will be given for 30 minutes. VR techniques for 10-15 minutes MI techniques for 05-10 minutes
Receives: Other: Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy
Group B: (Virtual Reality + Routine Physical Therapy )ExperimentalThe VR system consisted of a wall-mounted display, a Nintendo Wii box, a Wii remote, and a Wii Fit board. The participants will be instructed to stand on Wii Fit board while interacting with the VR system and playing the selected games. Routine physical therapy protocol will be given for 30 minutes along with cycling and walking for 10-15 minutes. VR techniques for 10-15 minutes.
Receives: Other: Virtual Reality + Routine Physical Therapy
Group C: (Motor Imagery +Routine Physical Therapy)ExperimentalDuring the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video. Routine physical therapy protocol will be given for 30 minutes along with Cycling and walking for 10-15 minutes MI techniques for 10-15 minutes
Receives: Other: Motor Imagery +Routine Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Berg Balance Scale

    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.

    Measured: 16 weeks

  2. Fugal-Meyer Scale

    Motor Function will be measured with Fugal-Meyer Scale. Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.

    Measured: 16 weeks

  3. Barthel Index

    Activities of Daily Living will be measured with Barthel Index. The Barthel Index for Activities of Daily Living is an ordinal scale which measures a person's ability to complete activities of daily living (ADL). A score of 95 or 100 (the Barthel Index was measured in 5-point increments between 0 and 100) was considered a favorable outcome.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start25 Feb 2024
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06308341
Sponsor's protocol ID
REC/RCR&AHS/23/0295
Status last verified
Oct 2024
First submitted
4 Mar 2024
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reznik ME, Drake J, Margolis SA, Moody S, Murray K, Costa S, Mahta A, Wendell LC, Thompson BB, Rao SS, Barrett AM, Boukrina O, Daiello LA, Asaad WF, Furie KL, Jones RN. Deconstructing Poststroke Delirium in a Prospective Cohort of Patients With Intracerebral Hemorrhage. Crit Care Med. 2020 Jan;48(1):111-118. doi: 10.1097/CCM.0000000000004031.

    PubMed 31567406

  • Yin XJ, Wang YJ, Ding XD, Shi TM. Effects of motor imagery training on lower limb motor function of patients with chronic stroke: A pilot single-blind randomized controlled trial. Int J Nurs Pract. 2022 Jun;28(3):e12933. doi: 10.1111/ijn.12933. Epub 2021 Apr 10.

    PubMed 33837986

  • Anwar N, Karimi H, Ahmad A, Gilani SA, Khalid K, Aslam AS, Hanif A. Virtual Reality Training Using Nintendo Wii Games for Patients With Stroke: Randomized Controlled Trial. JMIR Serious Games. 2022 Jun 13;10(2):e29830. doi: 10.2196/29830.

    PubMed 35699989

  • Wang X, Carcel C, Woodward M, Schutte AE. Blood Pressure and Stroke: A Review of Sex- and Ethnic/Racial-Specific Attributes to the Epidemiology, Pathophysiology, and Management of Raised Blood Pressure. Stroke. 2022 Apr;53(4):1114-1133. doi: 10.1161/STROKEAHA.121.035852. Epub 2022 Mar 28.

    PubMed 35344416

  • Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

    PubMed 21571152

  • Gaughan TCLS, Boe SG. Investigating the dose-response relationship between motor imagery and motor recovery of upper-limb impairment and function in chronic stroke: A scoping review. J Neuropsychol. 2022 Mar;16(1):54-74. doi: 10.1111/jnp.12261. Epub 2021 Aug 16.

    PubMed 34396708

  • Schuster-Amft C, Eng K, Suica Z, Thaler I, Signer S, Lehmann I, Schmid L, McCaskey MA, Hawkins M, Verra ML, Kiper D. Effect of a four-week virtual reality-based training versus conventional therapy on upper limb motor function after stroke: A multicenter parallel group randomized trial. PLoS One. 2018 Oct 24;13(10):e0204455. doi: 10.1371/journal.pone.0204455. eCollection 2018.

    PubMed 30356229

  • Dickstein R, Deutsch JE, Yoeli Y, Kafri M, Falash F, Dunsky A, Eshet A, Alexander N. Effects of integrated motor imagery practice on gait of individuals with chronic stroke: a half-crossover randomized study. Arch Phys Med Rehabil. 2013 Nov;94(11):2119-25. doi: 10.1016/j.apmr.2013.06.031. Epub 2013 Jul 18.

    PubMed 23872048

  • Patsaki I, Dimitriadi N, Despoti A, Tzoumi D, Leventakis N, Roussou G, Papathanasiou A, Nanas S, Karatzanos E. The effectiveness of immersive virtual reality in physical recovery of stroke patients: A systematic review. Front Syst Neurosci. 2022 Sep 22;16:880447. doi: 10.3389/fnsys.2022.880447. eCollection 2022.

    PubMed 36211591

  • Sip P, Kozlowska M, Czysz D, Daroszewski P, Lisinski P. Perspectives of Motor Functional Upper Extremity Recovery with the Use of Immersive Virtual Reality in Stroke Patients. Sensors (Basel). 2023 Jan 8;23(2):712. doi: 10.3390/s23020712.

    PubMed 36679511

  • Chen J, Or CK, Chen T. Effectiveness of Using Virtual Reality-Supported Exercise Therapy for Upper Extremity Motor Rehabilitation in Patients With Stroke: Systematic Review and Meta-analysis of Randomized Controlled Trials. J Med Internet Res. 2022 Jun 20;24(6):e24111. doi: 10.2196/24111.

    PubMed 35723907

  • Felipe FA, de Carvalho FO, Silva ER, Santos NGL, Fontes PA, de Almeida AS, Garcao DC, Nunes PS, de Souza Araujo AA. Evaluation instruments for physical therapy using virtual reality in stroke patients: a systematic review. Physiotherapy. 2020 Mar;106:194-210. doi: 10.1016/j.physio.2019.05.005. Epub 2019 Jun 5.

    PubMed 31542173

  • Lee SY, Kim DY, Sohn MK, Lee J, Lee SG, Shin YI, Kim SY, Oh GJ, Lee YH, Lee YS, Joo MC, Lee SY, Ahn J, Chang WH, Choi JY, Kang SH, Kim IY, Han J, Kim YH. Determining the cut-off score for the Modified Barthel Index and the Modified Rankin Scale for assessment of functional independence and residual disability after stroke. PLoS One. 2020 Jan 29;15(1):e0226324. doi: 10.1371/journal.pone.0226324. eCollection 2020.

    PubMed 31995563

  • Kouvelioti V, Kellis E, Kofotolis N, Amiridis I. Reliability of Single-leg and Double-leg Balance Tests in Subjects with Anterior Cruciate Ligament Reconstruction and Controls. Res Sports Med. 2015;23(2):151-66. doi: 10.1080/15438627.2015.1005292. Epub 2015 Feb 4.

    PubMed 25649642

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy, Virtual Reality + Routine Physical Therapy and Motor Imagery +Routine Physical Therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06308341, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.

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