NCT07308054

Brief Summary

This randomized controlled trial aims to evaluate the effects of Fresnel prism glasses on visual perception, balance, gait, and functional independence in post-stroke patients. Stroke survivors, particularly those with right hemisphere involvement, often experience visuospatial deficits such as unilateral spatial neglect, leading to impaired balance, abnormal gait, and reduced functional independence. Fresnel prism glasses offer a low-cost, non-invasive intervention that may improve visuospatial alignment and postural control by modifying visual input. Adult post-stroke patients will be randomly allocated into an intervention group receiving Fresnel prism glasses alongside conventional physical therapy, and a control group receiving conventional therapy alone. Outcome measures will include the Motor-Free Visual Perception Test, Berg Balance Scale, Functional Independence Measure, and JAKC Observational Gait Analysis. Assessments will be conducted at baseline, post-intervention, and follow-up. The study is expected to provide evidence on whether Fresnel prism glasses can serve as an effective adjunct to conventional rehabilitation for improving mobility, balance, and functional outcomes in stroke survivors.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
0mo left

Started Dec 2025

Shorter than P25 for not_applicable stroke

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Dec 2025May 2026

Study Start

First participant enrolled

December 13, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2026

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

Visual PerceptionFunctional IndependenceFresnel Prism GlassesGaitBalance

Outcome Measures

Primary Outcomes (4)

  • Motor-Free Visual Perception Test

    The Motor-Free Visual Perception Test (MVPT) is a standardized assessment tool consisting of 36 items that evaluate multiple domains of visual perception, including figure-ground discrimination, visual discrimination, visual memory, visual closure, and spatial relationships. It is designed to assess visual field deficits and overall visual perceptual function in patients who have experienced brain injuries or strokes. In this study, we measured participants' response behaviors to identify the extent of unilateral neglect by recording their responses to both the left and right sides of the body, regardless of accuracy. Correct responses are scored as raw points, while the total time taken to complete the assessment is recorded as the visual perceptual processing time. The maximum score achievable is 36 points. The MVPT demonstrates high reliability, with a test-retest intraclass correlation coefficient (ICC) of 0.92 (95% CI: 0.84-0.96). In this trial, the MVPT will be utilized.

    Baseline, before intervention, 8 weeks post intervention

  • Berg Balance Scale

    The Functional Independence Measure (FIM) is a key tool used to assess the level of disability in patients undergoing rehabilitation. It evaluates 18 different activities of daily living on a scale from 1 to 7, where 1 means the person is fully dependent and 7 means they can do everything independently without any assistance. The highest possible score is 126, which signifies complete functional independence, while the lowest score of 18 indicates total dependence. The activities are divided into two main categories: 13 motor skills (like personal care, sphincter control, mobility, and locomotion) and five cognitive skills (which include communication and social cognition)

    baseline, before interventio, 8 weeks post intervention

  • Functional Independence Measure

    Independence Measure (FIM) is a key tool used to assess the level of disability in patients undergoing rehabilitation. It evaluates 18 different activities of daily living on a scale from 1 to 7, where 1 means the person is fully dependent and 7 means they can do everything independently without any assistance(23). The highest possible score is 126, which signifies complete functional independence, while the lowest score of 18 indicates total dependence. The activities are divided into two main categories: 13 motor skills (like personal care, sphincter control, mobility, and locomotion) and five cognitive skills (which include communication and social cognition)

    baseline, before intervention, 8 weeks post intervention

  • JAKC's Observational Gait Analysis

    The JAKC Observational Gait Analysis (Joint Angle Kinematic Coordination) is a wellstructured clinical tool designed to evaluate gait patterns, especially in individuals dealing with neurological or musculoskeletal issues like stroke. It zeroes in on the coordination and quality of movement in key joints-namely the hip, knee, ankle, and trunk-throughout various stages of the gait cycle. By closely observing joint angles, timing, and how limbs work together, therapists can spot unusual movement patterns and compensatory behaviors. The JAKC scale aids in clinical decision-making by pinpointing specific gait deviations, which helps in crafting targeted interventions and tracking progress over time. It's a practical, non-invasive approach that's widely embraced in rehabilitation environments

    Baseline, before intervention, 8 week post intervention

Study Arms (2)

Arm/group

EXPERIMENTAL

Participants allocated to the experimental group will receive Fresnel prism glasses (15 prism diopters) in addition to conventional physiotherapy. The Fresnel prism lenses will be affixed to the participant's spectacles to induce visuospatial realignment during therapeutic activities. Participants will wear the prism glasses during supervised rehabilitation sessions focused on balance training, gait training, and functional mobility tasks. Conventional physiotherapy will include postural control exercises, weight-shifting activities, gait re-education, and task-oriented functional training. The intervention will be administered for 4 weeks, with sessions conducted 5 days per week, under the supervision of a qualified physiotherapist.

Device: Fresnel Prism GlasseBehavioral: Convetional physical therapy

Arm/Group

ACTIVE COMPARATOR

Participants allocated to the control group will receive conventional physiotherapy alone, without the use of Fresnel prism glasses. The rehabilitation program will follow standard neurorehabilitation protocols and will include balance exercises, gait training, strengthening, postural alignment exercises, and functional mobility tasks. Therapy will be provided with the same frequency and duration as the experimental group (5 sessions per week for 4 weeks) to ensure comparability between groups.

Behavioral: Convetional physical therapy

Interventions

Fresnel prism glasses consist of lightweight, flexible, press-on plastic prism lenses with a power of 15 prism diopters, affixed to the inner surface of standard spectacle lenses. The prisms are designed to shift the visual field horizontally to promote visuospatial realignment and improve sensory integration during functional activities. Participants assigned to the experimental group will wear Fresnel prism glasses during supervised physiotherapy sessions. The intervention will be administered alongside conventional physiotherapy, including balance training, gait training, postural control exercises, and functional mobility tasks. The prism glasses will be worn throughout the therapy session to facilitate visual feedback and encourage symmetrical weight-bearing and improved postural alignment. The intervention will be delivered for a duration of 4 weeks, with sessions conducted 5 days per week. Each session will last approximately 30-45 minutes and will be supervised by a qualified

Arm/group

Conventional physiotherapy will be provided to all participants in both groups according to standard neurorehabilitation protocols. The program will include balance exercises, gait training, strengthening exercises, postural alignment activities, weight-shifting exercises, and task-oriented functional training. Participants in the control group will receive conventional physiotherapy alone, without Fresnel prism glasses, for the same duration and frequency as the experimental group.

Arm/GroupArm/group

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ha SY, Sung YH. Effects of Fresnel prism glasses on balance and gait in stroke patients with hemiplegia: A randomized controlled trial pilot study. Technol Health Care. 2020;28(6):625-633. doi: 10.3233/THC-191973.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Muhammad Asad Azam, Master of physical therapy

CONTACT

Salwa Atta, Supervisor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After recruitment of participants into the study, they will be allocated to their respective group utilizing the online randomization tool.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 29, 2025

Study Start

December 13, 2025

Primary Completion (Estimated)

May 26, 2026

Study Completion (Estimated)

May 26, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share