Analysis of the Effectiveness of Visual Training in Stroke Rehabilitation

August 30, 2024 updated by: Dr. Asim Waris, National University of Science and Technology, Pakistan
The study was a randomized control trial conducted to determine whether VR games incorporated with cognitive engagement within visual training feedback are feasible intervention options in stroke rehabilitation. An investigation has been conducted to assess the efficacy of virtual reality games that enhance hand motor functions to attain long-lasting improvements. Patients were randomly assigned to the experimental and control groups. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week, for a total duration of 6 weeks. Developed four VR-based hand games that include hitting a rolling ball, grasping a balloon, swapping hands, and gripping a pencil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The field of stroke rehabilitation frequently faces limitations in therapies and struggles to achieve long-lasting improvements in hand motor function. The integration of fully immersive virtual reality (VR) games with visual training feedback significantly improves the efficacy of stroke rehabilitation. Virtual reality (VR) games that incorporate repetitive and particular tasks stimulate the gradual activation of brain pathways linked to motor activities. VR research has the potential to enhance VR intervention games by combining cognitive engagement with visual feedback.

The objective of this study was to develop and evaluate virtual reality games that utilize an approach of cognitive engagement within visual feedback in order to enhance hand-motor capabilities. The study utilized completely immersive virtual reality (VR) games specifically designed for subacute stroke patients. The implementation of fully immersive virtual reality (VR) games as an intervention proved to be highly effective in significantly maintaining the motor recovery of patients who had experienced a stroke in the subacute phase. Stroke patients exhibited enhanced dexterity, heightened range of motion, greater hand strength, and improved grip.

Developed VR games utilize a virtual reality device and are designed to be controlled by hand movements such as flexion/extension, close/open, supination/pronation, and pinch. Patients were randomly assigned to the experimental and control groups. The experimental group received a VR hand game intervention with conventional physical therapy, while the control group only received conventional physical therapy. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks.

Study Type

Interventional

Enrollment (Actual)

52

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
      • Rawalpindi, Punjab, Pakistan, 46000
        • Physiotherapy Department, Holy Family Hospital.

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:

  • Montreal Cognitive Assessment (MOCA ≥ 21)
  • Modified Ashworth Scale (MAS< 4)
  • Fugl-Meyer Assessment (FMA between 25 and 55)
  • Age ≥ 18 years
  • Stroke patient type (Subacute patients)

Exclusion Criteria:

  • Wrist Impairments
  • Contractures
  • Patients with vestibular issues
  • Permanent external fixation

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group: Virtual reality intervention plus conventional physical therapy
The experimental group initially got VR intervention by playing all four easy-level games twice for three minutes each during the first and second weeks. This group again underwent VR intervention, playing all four same games with a difficulty level of twice 5 min duration for the third, fourth, fifth, and sixth weeks. The experimental group had an intervention of 24 sessions, lasting 4 days/week for a total of 6 weeks. During the first two weeks, patients received 24 minutes of VR hand games and 24 minutes of therapy sessions per day and for the next four weeks, this group received 40 minutes of VR hand games and 40 minutes of conventional therapy session per day. This group received conventional physical therapy that consists of range of motion, stretching, resistance, and strengthening exercises. At follow-up of two weeks this group only received conventional physical therapy.
Device: Virtual reality Game intervention plus conventional physical therapy
The experimental group initially got VR intervention by playing all four easy-level games named hitting a rolling ball, grasping a balloon, swapping hands, and gripping twice for three minutes each during the first and second weeks. This group again underwent VR intervention by playing all four same games with a difficulty level twice 5 min duration for the third, fourth, fifth, and sixth weeks. The experimental group had an intervention of 24 sessions, lasting 4 days/week for a total of 6 weeks. During the first two weeks, patients received 24 minutes of VR hand games and 24 minutes of therapy sessions per day and for the next four weeks, this group received 40 minutes of VR hand games and 40 minutes of conventional therapy session per day. This group received conventional physical therapy that consists of range of motion, stretching, resistance, and strengthening exercises. At follow-up of two weeks this group only received conventional physical therapy.
Other Names:
  • VRGI+CPT
Active Comparator: Control Group: Conventional physical therapy
The control group received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises. The CPT group had a conventional intervention of 24 sessions, lasting 4 days per week for a total of 6 weeks. The CPT group was given 48 minutes of conventional physical therapy sessions per day for weeks 1 and 2, followed by 80 minutes of conventional physical therapy sessions per day for the next 4 weeks. At a follow-up of two weeks, this group also received conventional physical therapy.
Device: Conventional Physical Therapy
The control group received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises by using powerweb, thera putty, and occupational therapy equipment. The CPT group had a conventional intervention of 24 sessions, lasting 4 days/week for a total of 6 weeks. The CPT group was given 48 minutes of conventional physical therapy sessions per day for weeks 1 and 2 followed by 80 minutes of conventional physical therapy sessions per day for the next 4 weeks. At follow-up of two weeks, this group also received conventional physical therapy.
Other Names:
  • CPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Time Frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
The Fugl-Meyer Assessment-Upper Extremity subscale was employed to examine the motor function restoration in the upper extremity of stroke patients following interventions. The Fugl-Meyer Assessment-Upper Extremity consists of 33 items that assess motor function, with a scoring range of 0-66, The minimum score 0 represents severe impairment, and maximum score 66 represents normal motor function. Higher scores indicate better motor function.
Baseline, 4th week, 6th week, and 9th week (follow-up)
Action Research Arm Test (ARAT)
Time Frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
The Action Research Arm Test is utilized to examine the functional capabilities of stroke patients upper extremities, specifically in terms of reaching, gripping, pinching, and overall movement tasks. Each item is allocated a rating score of 4 points, with the potential total values ranging from 0 to 57. The minimum score 0 represents severe impairment, and the maximum score 57 represents normal upper extremity function. Higher scores on the Action Research Arm Test indicate better functional capabilities of the upper extremities.
Baseline, 4th week, 6th week, and 9th week (follow-up)
Box and Block Test (BBT)
Time Frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
The BBT evaluated the manual dexterity of individuals who had suffered a stroke. During this assessment, participants are required to transfer blocks from one container to another within a one-minute time limit.
Baseline, 4th week, 6th week, and 9th week (follow-up)
Correlation between electromyography signal features and clinical outcomes
Time Frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
Electromyography signals are obtained in order to evaluate the electrical activity generated by muscles. Electromyography was utilized for the objective assessment of the effectiveness of immersive VR-based hand games. The objective assessment includes the evaluation of the correlation between electromyography signal features and clinical outcomes, which includes the Fugl-Meyer Assessment-Upper Extremity, Action Research Arm Test, and Box and Block Test.
Baseline, 4th week, 6th week, and 9th week (follow-up)
Movement performance
Time Frame: Baseline, 4th week, 6th week, and 9th week (follow-up)
The weekly movement performance was evaluated by machine learning algorithms that include k-nearest neighbors, random forest, and support vector machine classifiers on the electromyography signals of stroke patients.
Baseline, 4th week, 6th week, and 9th week (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Barthel Index (MBI)
Time Frame: Baseline and 9th week (follow-up)
The Modified Barthel Index assesses an individual's ability to perform both practical and routine tasks independently. The Modified Barthel Index consists of 10 items, each scored based on the level of assistance required or the level of autonomy demonstrated by the patient. The total score ranges from a minimum of 0 to a maximum of 20. Lower scores indicate greater dependence, with scores below 10 typically representing severe disability and scores below 15 usually indicating moderate disability. Moreover, higher scores reflect greater independence in performing daily activities.
Baseline and 9th week (follow-up)
Stroke-Specific Quality of Life (SSQOL)
Time Frame: Baseline and 9th week (follow-up)
The Stroke-Specific Quality of Life measure was used to assess the health-related quality of life of stroke survivors. The Stroke-Specific Quality of Life scale consists of 49 comprehensive items that evaluate various aspects of quality of life based on the patient's current state. The total score ranges from a minimum of 49 to a maximum of 245. Lower scores indicate poorer health-related quality of life, and higher scores indicate better health-related quality of life.
Baseline and 9th week (follow-up)

Collaborators and Investigators

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

Sponsor

National University of Science and Technology, Pakistan

Investigators

  • Study Chair: Asim Waris, PhD, National University of Sciences and Technology (NUST), Islamabad, Pakistan

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)

November 14, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

August 24, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMES/REC/22/027

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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