Unsupervised robot-assisted rehabilitation after stroke: feasibility, effect on therapy dose, and user experience.

BACKGROUND: Unsupervised robot-assisted rehabilitation is a promising approach to increase the dose of therapy after stroke, which may help promote sensorimotor recovery without requiring significant additional resources and manpower. However, the unsupervised use of robotic technologies is not yet a standard, as rehabilitation robots often show low usability or are considered unsafe to be used by patients independently. In this paper we explore the feasibility of unsupervised therapy with an upper limb rehabilitation robot in a clinical setting, evaluate the effect on the overall therapy dose, and assess user experience during unsupervised use of the robot and its usability. METHODS: Subacute stroke patients underwent a four-week protocol composed of daily 45 min-sessions of robot-assisted therapy. The first week consisted of supervised therapy, where a therapist explained how to interact with the device. The second week was minimally supervised, i.e., the therapist was present but intervened only if needed. After this phase, if participants learnt how to use the device, they proceeded to two weeks of fully unsupervised training. Feasibility, dose of robot-assisted therapy achieved during unsupervised use, user experience, and usability of the device were evaluated. Questionnaires to evaluate usability and user experience were performed after the minimally supervised week and at the end of the study, to evaluate the impact of therapists' absence. RESULTS: Unsupervised robot-assisted therapy was found to be feasible, as 12 out of the 13 recruited participants could progress to unsupervised training. During the two weeks of unsupervised therapy participants on average performed an additional 360 min of robot-assisted rehabilitation. Participants were satisfied with the device usability (mean System Usability Scale scores > 79), and no adverse events or device deficiencies occurred. CONCLUSIONS: We demonstrated that unsupervised robot-assisted therapy in a clinical setting with an actuated device for the upper limb was feasible and can lead to a meaningful increase in therapy dose. These results support the application of unsupervised robot-assisted therapy as a complement to usual care in clinical settings and pave the way to its application in home settings. TRIAL REGISTRATION: Registered on 13.05.2020 on clinicaltrials.gov (NCT04388891).

Progressive Transition From Supervised to Unsupervised Robot-Assisted Therapy After Stroke: Protocol for a Single-Group, Interventional Feasibility Study.

BACKGROUND: Increasing the dose of therapy delivered to patients with stroke may improve functional outcomes and quality of life. Unsupervised technology-assisted rehabilitation is a promising way to increase the dose of therapy without dramatically increasing the burden on the health care system. Despite the many existing technologies for unsupervised rehabilitation, active rehabilitation robots have rarely been tested in a fully unsupervised way. Furthermore, the outcomes of unsupervised technology-assisted therapy (eg, feasibility, acceptance, and increase in therapy dose) vary widely. This might be due to the use of different technologies as well as to the broad range of methods applied to teach the patients how to independently train with a technology. OBJECTIVE: This paper describes the study design of a clinical study investigating the feasibility of unsupervised therapy with an active robot and of a systematic approach for the progressive transition from supervised to unsupervised use of a rehabilitation technology in a clinical setting. The effect of unsupervised therapy on achievable therapy dose, user experience in this therapy setting, and the usability of the rehabilitation technology are also evaluated. METHODS: Participants of the clinical study are inpatients of a rehabilitation clinic with subacute stroke undergoing a 4-week intervention where they train with a hand rehabilitation robot. The first week of the intervention is supervised by a therapist, who teaches participants how to interact and train with the device. The second week consists of minimally supervised therapy, where the therapist is present but intervenes only if needed as participants exercise with the device. If the participants properly learn how to train with the device, they proceed to the unsupervised phase and train without any supervision during the third and fourth weeks. Throughout the duration of the study, data on feasibility and therapy dose (ie, duration and repetitions) are collected. Usability and user experience are evaluated at the end of the second (ie, minimally supervised) and fourth (ie, unsupervised) weeks, allowing us to investigate the effect of therapist absence. RESULTS: As of April 2023, 13 patients were recruited and completed the protocol, with no reported adverse events. CONCLUSIONS: This study will inform on the feasibility of fully unsupervised rehabilitation with an active rehabilitation robot in a clinical setting and its effect on therapy dose. Furthermore, if successful, the proposed systematic approach for a progressive transition from supervised to unsupervised technology-assisted rehabilitation could serve as a benchmark to allow for easier comparisons between different technologies. This approach could also be extended to the application of such technologies in the home environment, as the supervised and minimally supervised sessions could be performed in the clinic, followed by unsupervised therapy at home after discharge. TRIAL REGISTRATION: ClinicalTrials.gov NCT04388891; https://clinicaltrials.gov/study/NCT04388891. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48485.

Transforming waiting pauses into opportunity for physical activity: the "Activate your Wait" pilot study.

BACKGROUND AND AIM: Physical activity is recognized as a major health determinant. However, the prevalence of inactivity can be as high as 80% in some adult subpopulations. From the urgent need to implement strategies to fight sedentary behaviour, considering that physical activity is defined as any bodily movement produced by skeletal muscles that require energy expenditure, the pilot study "Activate your Wait" was born. The project aim is to transform waiting pauses during everyday life into opportunities to perform simple stretching and active mobilization exercises. METHODS: The pilot study was carried out in 2019 at Terme S. Egidio (Italy). It was divided in three phases: in the pre-intervention a questionnaire was used to evaluate the interest in the project (96 responders); during the intervention, examples of simple exercises that people can do by themselves were illustrated and undertaken by about 120 participants; in the post-intervention an evaluation questionnaire was administered (71 responders). RESULTS: The intervention aroused enthusiastic participation and high approval and resulted in an increase both in willingness to perform exercises during daily waiting pauses (68% vs 94%) and belief in positive results of physical activity on health (74% vs 96%). CONCLUSIONS: In a context where the opportunities for physical activity are decreasing and a sedentary lifestyle has reached a high level, this project represents a contribution to the increase in the awareness of the importance of physical activity and the promotion of the culture of movement in the entire population, with an opportunity of easy accessibility in different contexts of life, at all ages.

Automatic and Personalized Adaptation of Therapy Parameters for Unsupervised Robot-Assisted Rehabilitation: a Pilot Evaluation.

Growing evidence shows that increasing the dose of upper limb therapy after stroke might improve functional outcomes and unsupervised robot-assisted therapy may be a solution to achieve such an increase without adding workload on therapists. However, most of existing robotic devices still need frequent supervision by trained personnel and are currently not designed or ready for unsupervised use. One reason for this is that most rehabilitation devices are not capable of delivering and adapting personalized therapy without external intervention. Here we present a set of clinically-inspired algorithms that automatically adapt therapy parameters in a personalized way and guide the course of robot-assisted therapy sessions. We implemented these algorithms on a robotic device for hand rehabilitation and tested them in a pilot study with 5 subacute stroke subjects over 10 robot-assisted therapy sessions, some of which unsupervised. Results show that our algorithms could adapt the therapy difficulty throughout the whole study without requiring external intervention, maintaining performance around a predefined 70% target value (mean performance for all the subjects over all the sessions: 64.5%). Moreover, the algorithms could guide patients through the therapy sessions, minimizing the number of actions that subjects had to learn and perform. These results open the door to the use of robotic devices in an unsupervised setting to increase therapy dose after stroke.

["Activate your Wait" project : pilot study carried out at a thermal centre]

Physical activity is recognised as a major health determinant, with positive effects on health, environmental sustainability and economy. National surveillance data show that one out of three Italians - adult and elderly alike - declares to be sedentary, with a progressively increasing trend. From the urgent need to implement strategies to promote physical activity the "Activate your Wait" ("Attiva l'Attesa") project was born, aimed at transforming the waiting pauses during day to day life into opportunities to perform simple stretching and active mobilization exercises. The pilot study was carried out at the Terme S. Egidio, Suio Terme Castelforte (Latina). The results of the questionnaire distributed in the pre-intervention phase, aimed at assessing the users' interest in the project and physical activity in general, are reported. The questionnaire was administrated in the waiting rooms in September 2018 and September 2019. A total of 129 subjects responded to the questionnaire: 43% declared themselves sedentary, 73% reported willingness to perform simple physical exercises while waiting, and 76% believed that physical activity during waiting moments could have a positive impact on health. The project's subsequent goal is to identify suitable exercises to be proposed during the intervention period, which can be easily reproduced independently by users in their everyday life.

Efficacy of Whole-Body Vibration Board Training on Strength in Athletes After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Study.

OBJECTIVE: To evaluate whether an 8-week whole-body vibration training program may improve recovery of knee flexion/extension muscular strength in athletes after arthroscopic anterior cruciate ligament (ACL) reconstruction. DESIGN: Randomized controlled trial. SETTING: Single outpatient rehabilitation center. PARTICIPANTS: Thirty-eight female volleyball/basketball players (aged between 20 and 30), randomized into 2 treatment groups. INTERVENTIONS: During a standardized six-month rehabilitation program, from week 13 to week 20 after surgery, the whole-body vibration group (n = 19) and the control group (n = 19) performed additional static knee flexor/extensor exercises on a vibration platform. For the whole-body vibration group, the vibration platform was set to 2.5 mm of amplitude and 26 Hz of frequency. The control group followed the same whole-body vibration board training with no vibrations. MAIN OUTCOME MEASURES: All patients were evaluated using an isokinetic strength test with a Biodex dynamometer at the beginning and at the end of the additional treatment protocol. The parameters tested were the peak torque and the maximum power of knee flexor and extensor muscles performing strength and endurance tests. RESULTS: No vibration-related side effects were observed. Improvements were noticed in both groups, but increase in knee muscle isokinetic strength values was statistically significant in the whole-body vibration group when compared with the control group (differences in extension: peak torque 11.316/10.263 N·m and maximum power 13.684/11.211 W; flexion: peak torque 9.632/11.105 N·m and maximum power 10.158/9.474 W; P < 0.001). CONCLUSIONS: When combined with a standardized rehabilitation program, whole-body vibration may increase muscular strength and be an effective additional treatment option in the rehabilitation of athletes after ACL arthroscopic reconstruction.

Short-term effect of local muscle vibration treatment versus sham therapy on upper limb in chronic post-stroke patients: a randomized controlled trial.

BACKGROUND: In recent years, local muscle vibration received considerable attention as a useful method for muscle stimulation in clinical therapy. Some studies described specific vibration training protocol, and few of them were conducted on post-stroke patients. Therefore there is a general uncertainty regarding the vibrations protocol. AIM: The aim of this study was to evaluate the effects of local muscle high frequency mechano-acoustic vibratory treatment on grip muscle strength, muscle tonus, disability and pain in post-stroke individuals with upper limb spasticity. DESIGN: Single-blind randomized controlled trial. SETTING: Outpatient rehabilitation center. POPULATION: Thirty-two chronic poststroke patients with upper-limb spasticity: 21 males, 11 females, mean age 61.59 years ±15.50, time passed from stroke 37.78±17.72 months. METHODS: The protocol treatment consisted of the application of local muscle vibration, set to a frequency of 300 Hz, for 30 minutes 3 times per week, for 12 sessions, applied to the skin covering the venter of triceps brachii and extensor carpi radialis longus and brevis muscles during voluntary isometric contraction. All participants were randomized in two groups: group A treated with vibration protocol; group B with sham therapy. All participants were evaluated before and after 4-week treatment with Hand Grip Strength Test, Modified Ashworth Scale, QuickDASH score, FIM scale, Fugl-Meyer Assessment, Jebsen-Taylor Hand Function Test and Verbal Numerical Rating Scale of pain. Outcomes between groups was compared using a repeated-measures ANOVA. RESULTS: Over 4 weeks, the values recorded in group A when compared to group B demonstrated statistically significant improvement in grip muscle strength, pain and quality of life and decrease of spasticity; P-values were <0.05 in all tested parameters. CONCLUSIONS: Rehabilitation treatment with local muscle high frequency (300 Hz) vibration for 30 minutes, 3 times a week for 4 weeks, could significantly improve muscle strength and decrease muscle tonus, disability and pain in upper limb of hemiplegic post-stroke patients. CLINICAL REHABILITATION IMPACT: Local muscle vibration treatment might be an additional and safe tool in the management of chronic poststroke patients, granted its high therapeutic efficiency, limited cost and short and repeatable protocol of use.

Efficacy of mechano-acoustic vibration on strength, pain, and function in poststroke rehabilitation: a pilot study.

BACKGROUND: Vibration therapy may be used to help cortical reorganization after stroke as it can cause different adaptive metabolic and mechanical effects. OBJECTIVE: This study examined whether the application of mechano-acoustic vibration on upper limb muscles could induce changes in range of motion (ROM), function, pain, and grip strength in individuals with chronic stroke. METHODS: Out of 52 individuals post stroke with upper limb spasticity who were eligible,16 received mechano-acoustic vibration therapy (ViSS device) 3 times weekly for 12 sessions. The frequency of vibration was set to 300 Hz for 30 minutes. The treated muscles were the extensor carpi radialis longus and brevis and triceps brachii during voluntary contraction. All participants were evaluated in both upper limbs before (T0) and at the end (T1) of treatment with a dynamometer (hand grip strength), Modified Ashworth Scale, QuickDASH, FIM score, Fugl-Meyer scale, Verbal Numerical Rating Scale of pain, and Jebsen-Taylor Hand Function Test. RESULTS: After 4 weeks, hand grip power had improved and pain and spasticity had decreased. Improvements were recorded for all parameters and were considered statistically significant. CONCLUSIONS: Application of vibratory stimuli to a muscle can increase the motor-evoked potential recorded from the muscle, suggesting an enhancement of corticospinal excitability. Low amplitude, high-frequency vibration treatment (300 Hz) can significantly decrease tone and pain and improve strength in upper limb of hemiplegic individuals, when applied for 30 minutes, 3 times a week over 4 weeks.

Effectiveness of Back School program versus hydrotherapy in elderly patients with chronic non-specific low back pain: a randomized clinical trial.

BACKGROUND AND AIM OF THE WORK: Chronic low back pain (CLBP) is a major cause of disability, for which clinical practice guidelines suggest exercise programs, such as Back School program (stretching and selective muscle reinforcement techniques) and Hydrotherapy technique, as an effective treatment to reduce pain intensity and disability. METHODS: We enrolled 56 elderly individuals, affected by non-specific CLBP, whose pain had worsened in the last three months, which were randomly allocated to Back School (group A) or to Hydrotherapy program (group B). Each group underwent two one-hour-treatment sessions per week, over a 12-week period. Each patient was evaluated using the Roland Morris Disability Questionnaire (RMDQ) and the 36-Item Short Form Health Survey (SF-36) V2.0 at the beginning (T0), at the end of treatment (T1) and at the 3-month follow-up (T2). RESULTS: At T1 and T2 we observed a highly significant statistical difference in the values measured  in both groups: at T1 in group A RMDQ improvement of 3.26±1.02 (p<0.001) and SF-36 of 13.30±1.44 (p<0.001); in group B RMDQ improvement of 4.96±0.71 (p<0.001) and SF-36 of 14.19±1.98 (p<0.001). We have also evaluated the difference in effectiveness of the two programs and no significant statistical differences were found between the two groups. CONCLUSIONS: Back School program and Hydrotherapy could be valid treatment options in the rehabilitation of non-specific CLBP in elderly people. Both therapies proved to be effective and can be used in association with other rehabilitation programs. We believe that Back School program should be favored for its simplicity and the small number of resources required.

Isokinetic strength test and functional outcomes in proximal humeral fractures treated with a locking plate.

BACKGROUND: Despite the use of many shoulder outcome scales in subjects with rotator cuff pathology or instability symptoms, it can be problematic to select an instrumental evaluation in the shoulder trauma population. In this study we evaluated patients with proximal humeral fractures treated with internal fixation with a locking plate, analyzing the recovery of strength with an isokinetic test and its correlation with clinical and functional outcomes. METHODS: We enrolled 46 individuals (17 men, 29 women). The evaluation included a structured interview, measurement of ROM, isokinetic strength test and Constant-Murley and QuickDASH scores. The isokinetic test was performed in flexion/extension and external/internal rotation of the operated shoulder in comparison with the contralateral side and concentric contractions in all movements. The parameter tested was peak torque. RESULTS: In the operated shoulder values we noticed a statistically significant correlation between the QuickDASH and Constant-Murley score. QuickDASH showed a significant correlation with flexion isokinetic strength, partial correlation with extension isokinetic values and no correlation with external/internal rotation values. In addition, we found a correlation between the Constant-Murley score and all the isokinetic strength parameters. Comparing the operated shoulder and the contralateral, in Neer type 2 fractures there was no significant difference in all the isokinetic peak torque values; in Neer type 3 and type 4, there was a significant statistical difference in both flexion peak torque values and no significant difference in the other movements. CONCLUSIONS: The isokinetic test can give objective data on strength recovery and could help the surgeon's clinical evaluation to assess the functional recovery of the operated shoulder over time. We believe that the isokinetic test and Constant-Murley score could act as a reference in the evaluation of post-surgical outcome of proximal humeral fractures. Furthermore, the type of fracture could be a post-surgical limb recovery predictor and the shoulder flexion force could be the best functionality recovery indicator.

Return to run after partial amputation of the ankle: clinical assessment and instrumental evaluation.

BACKGROUND AND AIM OF THE WORK: the traumatic amputation or partial amputation of a portion of the lower limb is one of the most serious and not so rare road accident and job injury. There are few cases reported of replantation of the lower extremities rather than amputation surgery. This work describes a case of partial amputation of the right ankle. METHODS: the emergency treatment consisted of rigorous lavage and debridement, reduction, stabilization of the ankle and restoreation of the neurovascular and soft tissues lesions. Because of cutaneous necrosis another surgical treatment of reverse rotation flap was needed. The good outcome has been documented with foot pressure analysis, stabilometric evaluation and gait and jump analysis based on measurements of acceleration. RESULTS: after seven months of personalized rehabilitation program the patient walks without devices, has recovered functional of range of movement and had no neurological deficit or subjective problems. Currently the subject has returned to his job and runs without pain. CONCLUSIONS: emergency foot salvage treatment was possible thanks to a close collaboration among different physicians with specialized skills, good emergency management and an adequate infrastructure.