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. 2018 Mar 5;2018(3):CD011290. doi: 10.1002/14651858.CD011290.pub2

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
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)
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
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
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
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