Here is the design of a clinical trial:

Official Title: Motor Imagery to Facilitate Sensorimotor Relearning (MOTIFS) After ACL Injury: A Randomized Controlled Trial

Included conditions:
- Anterior Cruciate Ligament Injury

Study Armgroups:
- {'label': 'Neuromuscular Training', 'type': 'NO_INTERVENTION', 'description': 'Participants in this group will undergo rehabilitation for ACL injury consisting of neuromuscular training according to care-as-usual treatment common to physical therapy professionals.'}
- {'label': 'MOTIFS', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive an intervention that has been developed according to our new training model, known as MOTor Imagery to Facilitate Sensorimotor re-learning (MOTIFS). In this intervention, patients will receive a neuromuscular training rehabilitation program with integrated dynamic motor imagery.', 'interventionNames': ['Behavioral: MOTIFS']}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'MOTIFS', 'description': 'o MOTor Imagery to Facilitate Sensorimotor re-learning (MOTIFS) is an individualized and physical activity-specific integrated model that includes aspects of both neuromuscular training, as used in rehabilitation practices, and Dynamic Motor Imagery (DMI). DMI is a form of mental training in which the participant images him-/herself performing a task from a first-person perspective in order to maximize functional equivalence to the task in question. This includes dynamic, physical movement, as well as mental imaging. The intervention provides a framework for designing individualized, physical activity-specific rehabilitation exercises for knee-injured people.', 'armGroupLabels': ['MOTIFS'], 'otherNames': ['Neuromuscular Training Plus Mental Training', 'Train the Brain Model']}

Primary Outcomes:
- {'measure': 'Side Hop', 'description': 'Change in hop performance on the injured leg from baseline to 12 weeks, expressed in number of hops completed', 'timeFrame': '12 weeks'}
- {'measure': 'Anterior Cruciate Ligament Return to Sport After Injury Scale', 'description': '12 question self-reported outcome scale measuring readiness to return to sport. Scale ranges from 0-10 for each question. Scores summed from 0 (worst) - 100 (best).', 'timeFrame': '12 months'}

Please estimate the sample size based on the assumption: 
Significance level set at p<0.025, power of 0.80, and an estimated 20% drop-out rate. Adjustments for clustering effects using observed within- and between-cluster variance to more accurately estimate ICC.
Sample size
          Based on previous studies examining ACL-RSI [49] and side-hop function [50], a preliminary sample size was estimated, to be used in the first phase of this adaptive RCT, which resulted in n=106 participants. This included adjustments for potential cluster effects using a preliminary Intra-Cluster Correlation Coefficient (ICC). An approximation is required as comparable studies are unavailable to reliably perform a sample size estimation. This is necessary in this phase in order to evaluate whether an intervention effect is detectable and within practical limitations, which will thereafter inform more accurate sample-size estimations.
          A new sample size will be calculated by a blinded third-party member of the data management committee using collected data from an interim analysis, therefore allowing for more accurate between-group differences in the main outcomes. Observed within- and between-cluster variance will also be calculated in order to more accurately estimate an Intra-Cluster Correlation Coefficient (ICC, denoted as Ï). This will be performed using the formula \documentclass[12pt]{minimal}
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				\begin{document}$$ \rho =\frac{s_b^2}{s_b^2+{s}_w^2} $$\end{document}Ï=sb2sb2+sw2 [51] in order to adjust for the fact that different clinics are included in the trial (i.e., potential clustering effects). The adjusted sample size will therefore be calculated using the formula \documentclass[12pt]{minimal}
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				\begin{document}$$ \frac{n_ik\left(1-\rho \right)}{k-{n}_i\rho } $$\end{document}nik1âÏkâniÏ [52], along with an estimated 20% drop-out rate, in order to reach a power of 0.80, with significance set at p<0.025. As an estimated sample size has been calculated, the new sample size will only be adjusted up; that is, the number of participants included will not be less than n=106 required in the original sample-size estimation.