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

October 24, 2024 updated by: Riphah International University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54660
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Presence of aphasia, apraxia, and hemineglect
  2. Serious cardiovascular disease (heart failure, arrhythmias, angina pectoris or myocardial infarction)
  3. Cerebellar lesion
  4. Multiple brain accidents
  5. Muscular disorder effect upper and lower extremities
  6. History of seizures or epilepsy.
  7. Patients whose injury occurred fewer than 6 months previously, considering the expected time for spontaneous recovery;
  8. Patients with associated disorders such as epilepsy, and sensory and perceptual deficits such as hemineglect and Pusher syndrome;
  9. 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
  10. Inability to commit to the study schedule or attend the required therapy sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A: (Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy)

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
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
Experimental: Group B: (Virtual Reality + Routine Physical Therapy )

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

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.
Experimental: Group C: (Motor Imagery +Routine Physical Therapy)

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Study Chair: Muhammad Kashif, PhD-PT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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