Determining the Effectiveness of a New Device for Hand Therapy (The FEPSim Device): Feasibility Protocol for a Randomized Controlled Trial Study
Authors: Miguel-Cruz Sr Antonio , Guptill Christine , Gregson Geoffrey , Ladurner Anna-Maria , Holmes Cindy , Yeung Daniel , Siebert Justine , Dziwenko Gwen , Ríos Rincón Adriana 
Published: April 2021

Background
Impairments of the forearm, wrist, and hand affect a sizable proportion of individuals and impose a significant economic burden on health care systems. FEPSim is a medical device for hand and wrist rehabilitation. The FEPSim device could be part of the standard of care for upper extremity rehabilitation during therapeutic activities to increase range of motion, dexterity, and strength. FEPSim has not yet been tested in a health care setting; therefore, a trial of the effectiveness of FEPSim in upper extremity rehabilitation is warranted.

Objective
This study aims to assess the feasibility of conducting a definitive trial in terms of recruitment, eligibility criteria, the type and number of diagnoses included, the length and dosage of the intervention, and data collection methods. This study also aims to gather clinical and statistical information as well as information related to the cost and usability, which allows for an economic evaluation of the device.

Methods
The trial will use a randomized controlled design comprising 47 intervention participants and 47 control group participants. Participants will be adults (age≥18 years) attending outpatient rehabilitation with limitations in their forearm, wrist, or hand function due to distal radial or ulnar fractures, stroke, or osteoarthritis. This study’s primary outcome variables are related to patients’ range of motion and strength, specifically active and passive wrist flexion and extension range of motion; active and passive forearm pronation and supination range of motion; grip strength; and pinch strength. The secondary outcome variables are related to patients’ perceived wrist pain and disability in activities of daily living. The patients’ perceived wrist pain and disability in activities of daily living will be measured using the patient-rated wrist evaluation questionnaire. The control group will receive the standard of care at each of the 2 hospital facilities (Glenrose Rehabilitation and Royal Alexandra Hospitals). The intervention group will receive the same standard of care as the control group at each facility and will use the FEPSim device for therapeutic activities to increase strength, range of motion, resistance, and dexterity. All the participants will be assessed at baseline (week 0); weeks 2, 4, and 8; and postintervention (week 10).

Results
The FEPSim study was launched in April 2020. This study is currently on hold because of the global COVID-19 pandemic. The recruitment process is expected to resume by September 2020, and the primary impact analysis is expected to be conducted by December 2020.

Conclusions
This study will provide valuable information on the measurement of comparative intervention effects, technology acceptance by hand therapists, and how associated treatment and product costs will contribute to the evidence planning process, which will be crucial for the future adoption of FEPSim.

Trial Registration
International Standard Randomized Controlled Trial Number Registry ISRCTN13656014; https://www.isrctn.com/ISRCTN13656014

International Registered Report Identifier (IRRID)
PRR1-10.2196/22145