Improving Upper Extremity Bradykinesia in Parkinson’s Disease: A Randomized Clinical Trial on the Use of Gravity-Supporting Exoskeletons

Abstract

Hand movements are particularly impaired in patients with Parkinson’s Disease (PD), contributing to functional disability and difficulties in activities of daily living. Growing evidence has shown that robot-assisted therapy may be considered an effective and reliable method for the delivery of the highly repetitive training that is needed to trigger neuroplasticity, as intensive, repetitive and task-oriented training could be an ideal strategy to facilitate the relearning of motor function and to minimize motor deficit. The purpose of this study is to evaluate the improvement of hand function with semi-autonomous exercises using an upper extremity exoskeleton in patients with PD. A multicenter, parallel-group, randomized clinical trial was then carried out at the IRCCS Centro Neurolesi Bonino-Pulejo (Messina, Italy). Thirty subjects with a diagnosis of PD and a Hoehn–Yahr score between 2 and 3 were enrolled in the study. Patients were 1:1 randomized into either the experimental group (ERT), receiving 45 min training daily, 6 days weekly, for 8 weeks with Armeo®Spring (Volketswil, Switzerland) (a gravity-supporting device), or the control group (CPT), which was subjected to the same amount of conventional physical therapy. Motor abilities were assessed before and after the end of the training. The main outcomes measures were the Nine-hole peg test and the motor section of the UPDRS. All patients belonging to ERT and 9 out of 15 patients belonging to the CPT completed the trial. ERT showed a greater improvement in the primary outcome measure (nine-hole peg test) than CPT. Moreover, a statistically significant improvement was found in ERT concerning upper limb mobility, and disease burden as compared to CPT. Using an upper extremity exoskeleton (i.e., the Armeo®Spring) for semi-autonomous training in an inpatient setting is a new perspective to train patients with PD to improve their dexterity, executive function and, potentially, quality of life.

Type, Timing, Frequency, and Durability of Outcome of Physical Therapy for Parkinson Disease

“…Most studies (27 [59%]) were published after 2016 (Table 1 and eAppendix 2 in Supplement 1). More than half of the trials were conducted in Italy (19 [41%]), Brazil (5 [11%]), or the US (5 [11%]) . A fraction of the remaining trials was conducted in the UK (4 [9%]) .…”

“…The number of participants per trial ranged between 15 and 762 participants. Thirty-two studies (70%) involved 50 participants or less, and 8 studies (17%) enrolled more than 100 participants . Only 2 studies had sample sizes exceeding 500 .…”

“…The mean age of participants ranged from 61 to 77 years. With respect to baseline disease severity, more than half of the trials (25 [54%]) included participants with a Hoehn and Yahr stage between 2 and 3. Overall, 44 trials (96%) used a parallel design and 2 (5%) used a crossover design .…”

“…With respect to baseline disease severity, more than half of the trials (25 [54%]) included participants with a Hoehn and Yahr stage between 2 and 3. Overall, 44 trials (96%) used a parallel design and 2 (5%) used a crossover design . Of the 44 parallel design trials, 43 (98%) were single-blinded and only 1 (2%) was double-blinded .…”

“…Overall, 44 trials (96%) used a parallel design and 2 (5%) used a crossover design . Of the 44 parallel design trials, 43 (98%) were single-blinded and only 1 (2%) was double-blinded . Overall, 45 trials (98%) were conducted in an outpatient setting and only 1 (2%) in an inpatient setting …”