Effect of Oculomotor Therapy in Individuals With Convergence Insufficiency

Not Applicable

Not yet recruiting

• Conditions: Convergence Insufficiency

• Registration Number: NCT07036263
• Lead Sponsor: University of Nove de Julho

Brief Summary

The aim of this study is to investigate the effect of oculomotor therapy in individuals with ocular convergence insufficiency.

Detailed Description

Seventy participants with convergence insufficiency (CI) will be randomly allocated into two groups: Experimental Group (EG) (n=35) and Control Group (CG) (n=35). The primary outcome will be CI assessed by the convergence test. Secondary outcomes will include quality of life, postural balance, and gait speed. The EG will undergo five sessions of oculomotor therapy (once a week), based on and adapted from the established protocol for CI treatment. Results: Outcomes will be assessed by blinded evaluators at baseline, one week after the end of the treatment, and at 1 and 3 months follow-up. The CG will not receive any intervention. Data will be analyzed using statistical tests with a significance level set at p \< 0.05.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-08-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Individuals diagnosed with convergence insufficiency (CI);
• Aged between 18 and 60 years;
• Physically active individuals;
• Without cognitive impairments;
• Without vestibular system impairments (e.g., dizziness).

Exclusion Criteria

• Diagnosis of neurodegenerative diseases (e.g., Parkinson's, ALS);
• Presence of dementia;
• History of stroke;
• Presence of vestibular disorders;
• Systemic neuromuscular diseases;
• Disabling musculoskeletal pain;
• Diagnosis of diabetic polyneuropathy;
• Use of joint prostheses;
• Ongoing physical therapy treatment;
• Lack of physical ability to perform the prescribed physical activities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
General mobility	3 months	General mobility will be assessed using the Timed 'Up-and-Go' test with time measured in seconds as the unit of measurement.

Secondary Outcome Measures

Name	Time	Method
Single-Leg Stance Test	3 months	The single-leg stance test is used to assess static balance and predict frailty, particularly in community-dwelling older adults. Participants will be asked to stand on one leg for a maximum of 30 seconds, first with eyes open and then with eyes closed. The duration will be measured in three trials per visual condition, and the longest time will be considered. Longer stance duration indicates better balance. The examiner will remain beside the participant to prevent any risk of falling.
Postural Control Assessment	3 months	Postural control will be evaluated using a force platform (BIOMEC 400 v1.1, EMG System Ltda®). Tests will be performed under four conditions: (1) eyes open; (2) eyes closed; (3) eyes open, single-leg stance (dominant leg); and (4) eyes closed, single-leg stance (dominant leg). The main parameters will be the center of pressure (CoP) sway velocity (cm/s), in both anteroposterior (AP) and mediolateral (ML) directions.