Thiagarajan 2014.
Methods | Oculomotor rehabilitation versus sham training for traumatic brain injury Allocation: single masked Masking: single masked Exclusions: 0 Losses: 0 Design: cross‐over RCT |
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Participants |
Country: USA Number of participants randomised: 12 Age: 29 ± 3 years Gender: not specified Aetiologies: type of acquired brain injury not specified Ocular motility condition: any acquired disorder Inclusion criteria: TBI onset at least one year post‐incident to ensure that any subsequent changes during training are not secondary to their natural neurological recovery function period (6‐9 months). Participants exhibit at least one symptom (e.g. skipping lines while reading, blur, diplopia, etc.) and one clinical sign (e.g. receded near point of convergence) of a non‐strabismic oculomotor dysfunction related to impaired sustained reading. Intact cognitive ability to perform the required tasks for the study. Stable systemic health. Exclusion criteria: persons over the age of 40 years, as they typically will not have sufficient accommodation to measure reliably. Best corrected visual acuity poorer than 20/30 in either eye. Constant strabismus, amblyopia, or ocular disease in either eye. Medications that alter oculomotor function or attentional state (or both) |
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Interventions |
Intervention: ocular motor rehabilitation — training of versions, vergence and accommodation for 15 minutes each interspaced with 5 minute rest intervals. Dose: 2 sessions of 60 minutes training per week, block of 6 weeks Control: sham treatment of basic reading tasks Dose: 2 sessions of 60 minutes training per week, block of 6 weeks Duration: 2 blocks of 6 weeks with one‐week interim wash‐out |
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Outcomes |
Measurements: Reading rate, infra‐red eye recording of reading eye movements, saccade ratio — progression and regression saccades by eye movement recording, binocular accommodative amplitude, near point of convergence, convergence insufficiency symptom survey questionnaire Timepoints: Baseline, 6 weeks and post final block |
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Notes |
Health economic costs: not reported Funding: US Army, DoD award, College of Optometrists in Vision Development and SUNY Graduate programme Dates of study: not reported Declaration of interests: no interests to declare Trial registration ID: not specified |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "During phase 1, every odd‐numbered subject first received OMT, and every even‐numbered subject first received ST, and vice‐versa during phase 2." |
Allocation concealment (selection bias) | High risk | Single‐masked |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "A cross‐over, interventional experimental design of a single‐blinded nature (for the subject) was used." Judgement comment: this implies the participants were masked to the intervention, but the intervention and control are so different it is likely that the participants may be influenced by knowledge of the intervention. It is unclear what the impact of this would have been and may be considered to be part of the intervention so we have graded this as unclear risk of bias. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not masked |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete data |
Selective reporting (reporting bias) | Unclear risk | No access to study protocol or trials registry entry. |
Other bias | High risk |
Additional risk of bias assessment for cross‐over study Was the cross‐over design suitable: probably not Was there a carry‐over effect: uncertain, no analysis done. Was only first period data are available: no, first period data not available Was the analysis correct: unclear, no estimates of effect reported, data for intervention group only reported Comparability of results with those from parallel‐group trials: no parallel group trials |
A & E: Accident and Emergency AIDS: acquired immune deficiency syndrome BT: botulinum toxin PD: prism dioptre RCT: randomised controlled trial SEM: standard error mean TBI: traumatic brain injury USPHS: United States Public Health Service