A randomized control trial comparing functional outcomes in patients with immediate post-operative hand stiffness mobilized by an automated assistive glove and conventional hand therapy and hand therapy alone.

Abstract

A prospective single-center randomized, controlled trial was performed to compare a portable, motorized assistive glove (MAG) and conventional hand therapy, with conventional therapy alone as a prophylactic measure to prevent the stiffness of the hand. The aim was to test the null hypothesis that there are no significant differences in the functional outcomes between the two modalities. Adult patients operated on either for hand fractures, flexor tendon, or neurovascular injuries were recruited at three weeks, randomized, and allocated to the trial. The wearable MAG device works on the principle of continuous passive movement and has an hour/twice-daily sessions of mobilization along with the conventional therapy. In the conventional group, standard mobilization protocols were followed under the guidance of hand therapists. The intervention was provided for six-weeks. All the patients were assessed for total active motion (TAM) and Quick-DASH scores at the baseline, six-weeks, and three-months. One hundred patients (controls - 41; study group - 59) were randomized. The mean TAM in the study and control group improved from (138° ± 15°, 145° ± 20°) to (233° ± 10°, 209° ± 18°) and the mean Quick-DASH score, from (55 ± 11, 57 ± 11) to (8 ± 9, 25 ± 15) respectively. The improvement was statistically significant. No patients were lost to follow-up, nor were adverse effects reported. The novel automated assistive device improves the Total active movement in patients with immediate post-operative hand-stiffness compared to conventional hand therapy.