JMIR Publications

ABSTRACT

Background:

Impairments of the forearm, wrist, and hand affect a sizable proportion of individuals and represents a significant economic burden for healthcare systems. The FEPSimTM (flexion, extension, pronation, and supination) is a medical device for hand and wrist rehabilitation. The FEPSimTM device could be part of the standard of care for upper extremity rehabilitation during therapeutic activities designed to increase range of motion, dexterity, and strength. The FEPSimTM has not yet been tested in a healthcare setting; therefore, a trial of the effectiveness of the FEPSimTM in upper extremity rehabilitation is warranted.

Objective:

The primary objective of this proposed study is 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 the data collection methods. This study also aims to gather clinical and statistical information, as well as information related to the cost and usability (adoption) of the new technology used in this study

Methods:

The trial will use a randomized controlled design comprising 47 intervention participants and 47 control group participants. Participants will be adults (18 years of age and older) attending outpatient rehabilitation with limitations in their forearm, wrist, or hand function due to distal radial/ulnar fractures, stroke, or osteoarthritis. This study’s primary outcome variables are related to range of motion and strength: 1) angles of active range of motion (AROM) and passive range of motion (PROM) of wrist flexion and extension, and forearm pronation and supination; 2) grip strength; and 3) pinch grip force. The secondary outcome variables are the patients’ perceived wrist pain and disability in activities of daily living. The control group will receive the standard of care at each of two hospital facilities. The intervention group will receive the same standard of care as the control group at each facility and will use the FEPSimTM device for the therapeutic activities to increase strength, range of motion, resistance, and dexterity. All of the participants will be assessed at baseline (week 0), weeks 4 and 8, and post-intervention (week 10).

Results:

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 the FEPSimTM.

Conclusions:

This study will provide valuable information on the measurement of comparative intervention effects, technology acceptance by hand therapists, and how associated treatment costs and product costings will contribute to the evidence planning process, which will be crucial for the future adoption of the FEPSimTM. Clinical Trial: International Registered Report Identifier (IRRID): ISRCTN13656014