Analysis of the Effectiveness of Visual Training in Stroke Rehabilitation

NCT ID: NCT06582303

Last Updated: 2024-09-03

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke, Subacute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subacute stroke patients were randomly assigned to the experimental group and the control group. The experimental group received a VR hand game intervention along 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. The VR intervention consists of four games that utilize a virtual reality device and are controlled by affected hand movements such as flexion/extension, close/open, supination/pronation, and pinch. The control group and experimental groups received conventional physical therapy, which consists of range of motion, stretching, resistance, and strengthening exercises.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual reality Game intervention plus conventional physical therapy

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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VRGI+CPT CPT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University of Science and Technology, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Dr. Asim Waris

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asim Waris, PhD

Role: STUDY_CHAIR

National University of Sciences and Technology (NUST), Islamabad, Pakistan

Locations

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Physiotherapy Department, Holy Family Hospital.

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Bae S, Park HS. Development of Immersive Virtual Reality-Based Hand Rehabilitation System Using a Gesture-Controlled Rhythm Game With Vibrotactile Feedback: An fNIRS Pilot Study. IEEE Trans Neural Syst Rehabil Eng. 2023;31:3732-3743. doi: 10.1109/TNSRE.2023.3312336. Epub 2023 Sep 28.

Reference Type BACKGROUND
PMID: 37669214 (View on PubMed)

Fregna G, Schincaglia N, Baroni A, Straudi S, Casile A. A novel immersive virtual reality environment for the motor rehabilitation of stroke patients: A feasibility study. Front Robot AI. 2022 Aug 29;9:906424. doi: 10.3389/frobt.2022.906424. eCollection 2022.

Reference Type BACKGROUND
PMID: 36105763 (View on PubMed)

Lange B, Koenig S, Chang CY, McConnell E, Suma E, Bolas M, Rizzo A. Designing informed game-based rehabilitation tasks leveraging advances in virtual reality. Disabil Rehabil. 2012;34(22):1863-70. doi: 10.3109/09638288.2012.670029. Epub 2012 Apr 12.

Reference Type BACKGROUND
PMID: 22494437 (View on PubMed)

Hernandez A, Bubyr L, Archambault PS, Higgins J, Levin MF, Kairy D. Virtual Reality-Based Rehabilitation as a Feasible and Engaging Tool for the Management of Chronic Poststroke Upper-Extremity Function Recovery: Randomized Controlled Trial. JMIR Serious Games. 2022 Sep 27;10(3):e37506. doi: 10.2196/37506.

Reference Type BACKGROUND
PMID: 36166289 (View on PubMed)

Huang J, Lin M, Fu J, Sun Y, Fang Q. An Immersive Motor Imagery Training System for Post-Stroke Rehabilitation Combining VR and EMG-based Real-Time Feedback. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:7590-7593. doi: 10.1109/EMBC46164.2021.9629767.

Reference Type BACKGROUND
PMID: 34892847 (View on PubMed)

Amin F, Waris A, Syed S, Amjad I, Umar M, Iqbal J, Omer Gilani S. Effectiveness of Immersive Virtual Reality-Based Hand Rehabilitation Games for Improving Hand Motor Functions in Subacute Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2024;32:2060-2069. doi: 10.1109/TNSRE.2024.3405852. Epub 2024 May 30.

Reference Type RESULT
PMID: 38801680 (View on PubMed)

Other Identifiers

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BMES/REC/22/027

Identifier Type: -

Identifier Source: org_study_id

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