The recruitment and retention of participants and the blinding of participants, health care providers, and data collectors present challenges for clinical trial investigators. This article reviews challenges and alternative strategies associated with these three important clinical trial activities. Common recruiting pitfalls, including low sample size, unfriendly study designs, suboptimal testing locations, and untimely recruitment are discussed together with strategies for overcoming these barriers. The use of active controls, technology-supported visit reminders, and up-front scheduling is recommended to prevent attrition and maximize retention of participants. Blinding is conceptualized as the process of concealing research design elements from key players in the research process. Strategies for blinding participants, health care providers, and data collectors are suggested.
This case report is the first in a series of reports designed to determine the feasibility of implementing game-based neurorehabilitation using telehealth technologies (GbN+TT) for children with cerebral palsy, evaluate the responsiveness of relevant outcome measures to changes in motor impairment and activity participation after intervention, and identify technological challenges associated with implementation of GbN+TT. The participant completed more than 56 hr of game-based neurorehabilitation over 8 wk using the Timocco platform in his home. The primary measures of motor impairment (Bruininks-Oseretsky Test of Motor Proficiency, Second Edition) and function (Pediatric Motor Activity Log) were both sensitive to change. Results indicate that it is feasible to administer GbN+TT to a child with cerebral palsy and monitor outcomes using standardized assessments.
It appears that the w/h UE FM is a promising tool to measure distal upper extremity movement in patients with little active paretic wrist and finger movement. This finding widens the segment of patients on whom the w/h UE FM can be effectively used and addresses a gap, as commonly used measures necessitate active distal upper extremity movement.
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