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

NCT06308341 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0295
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

Activities of Daily Living; Stroke; Motor Control; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (3)

• 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.

  16 weeks

• 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.

  16 weeks

• 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.

  16 weeks

Study Arms (3)

Group A: (Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy)

OTHER

Participants 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

Other: Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy

Group B: (Virtual Reality + Routine Physical Therapy )

EXPERIMENTAL

The 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.

Other: Virtual Reality + Routine Physical Therapy

Group C: (Motor Imagery +Routine Physical Therapy)

EXPERIMENTAL

During 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

Other: Motor Imagery +Routine Physical Therapy

Interventions

Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy OTHER

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

Group A: (Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy)

Virtual Reality + Routine Physical Therapy OTHER

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.

Group B: (Virtual Reality + Routine Physical Therapy )

Motor Imagery +Routine Physical Therapy OTHER

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.

Group C: (Motor Imagery +Routine Physical Therapy)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

Related Publications (14)

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  PMID: 33837986 BACKGROUND

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  PMID: 35344416 BACKGROUND

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• 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.

  PMID: 34396708 BACKGROUND

• 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.

  PMID: 30356229 BACKGROUND

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• 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.

  PMID: 36679511 BACKGROUND

• 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.

  PMID: 35723907 BACKGROUND

• 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.

  PMID: 31542173 BACKGROUND

• 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.

  PMID: 31995563 BACKGROUND

• 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.

  PMID: 25649642 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammad Kashif, PhD-PT

  Riphah International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 13, 2024
• Study Start: February 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)