The Short-Term Efficacy of Integrating the Easy-Flex Device with Inpatient Rehabilitation in Total Knee Arthroplasty Patients: Insights from a Single-Blind Randomized Controlled Trial.

ABSTRACT

OBJECTIVE: To determine the effect of Easy-Flex as an adjunct to standard inpatient rehabilitation on clinical and functional outcomes. DESIGN: Prospective randomized controlled trial SETTING: Outpatient clinic and research laboratory PARTICIPANTS: A total of 44 patients were randomized to the Easy-Flex Group (EFG) or Control Group (CG). INTERVENTION A rehabilitation program averaging 50-60 minutes per day was implemented for the CG patients. In the EFG, in addition to 30-40 minutes of exercise with the Easy-Flex, the rehabilitation program applied to the CG was integrated with reduced sets and repetitions, with an average duration of 20 minutes. All interventions were performed under the supervision of a physiotherapist during hospitalization. After discharge, both groups received the same home exercise program. OUTCOME MEASUREMENTS The primary outcome is the flexion and extension range of motion (ROM). The secondary outcomes include the Numeric Pain Rating Scale (NPRS), Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Five Times Sit-to-Stand Test (5TSST), 10-Meter Walking Test (10MWT), Short Form-12v2, and Global Rating of Change score (GRCS). RESULTS: After 6 weeks, the overall group-by-time interaction for the 2 × 3 mixed-model ANOVA was found to be significant for flexion ROM (p=0.005), NPRS-rest (p=0.04), NPRS-activity (p=0.01), 10-MWT (p=0.003), WOMAC (p=0.021) and SF-12-PCS (p=0.032) in favor of EFG exercising with Easy-Flex in addition to standard rehabilitation. The between-group differences in favor of the EFG were -8.0° knee ROM, 1.35 to 1.5 points for pain intensity, and 0.12 m/sec for gait speed. Furthermore, differences favouring EFG in NPRS-rest,10-MWT speed, and SF-12 PCS were greater than the reported MCID. CONCLUSIONS: Incorporating Easy-Flex into standard physical therapy can be a beneficial, safe, and effective approach in clinical practice, as patients undergoing TKA typically prioritize improving their quality of life by reducing pain and increasing ROM.