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

NCT ID: NCT06308341

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-25

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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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

Group Type OTHER

Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy

Intervention Type 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 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.

Group Type EXPERIMENTAL

Virtual Reality + Routine Physical Therapy

Intervention Type 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 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

Group Type EXPERIMENTAL

Motor Imagery +Routine Physical Therapy

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muhammad Kashif, PhD-PT

Role: STUDY_CHAIR

Riphah International University

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

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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.

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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.

Reference Type BACKGROUND
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Other Identifiers

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REC/RCR&AHS/23/0295

Identifier Type: -

Identifier Source: org_study_id

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