Therapy effect on hand function after home use of a wearable assistive soft-robotic glove supporting grip strength.

BACKGROUND: Soft-robotic gloves with an assist-as-needed control have the ability to assist daily activities where needed, while stimulating active and highly functional movements within the user's possibilities. Employment of hand activities with glove support might act as training for unsupported hand function. OBJECTIVE: To evaluate the therapeutic effect of a grip-supporting soft-robotic glove as an assistive device at home during daily activities. METHODS: This multicentre intervention trial consisted of 3 pre-assessments (averaged if steady state = PRE), one post-assessment (POST), and one follow-up assessment (FU). Participants with chronic hand function limitations were included. Participants used the Carbonhand glove during six weeks in their home environment on their most affected hand. They were free to choose which activities to use the glove with and for how long. The primary outcome measure was grip strength, secondary outcome measures were pinch strength, hand function and glove use time. RESULTS: 63 patients with limitations in hand function resulting from various disorders were included. Significant improvements (difference PRE-POST) were found for grip strength (+1.9 kg, CI 0.8 to 3.1; p = 0.002) and hand function, as measured by Jebson-Taylor Hand Function Test (-7.7 s, CI -13.4 to -1.9; p = 0.002) and Action Research Arm Test (+1.0 point, IQR 2.0; p≤0.001). Improvements persisted at FU. Pinch strength improved slightly in all fingers over six-week glove use, however these differences didn't achieve significance. Participants used the soft-robotic glove for a total average of 33.0 hours (SD 35.3), equivalent to 330 min/week (SD 354) or 47 min/day (SD 51). No serious adverse events occurred. CONCLUSION: The present findings showed that six weeks use of a grip-supporting soft-robotic glove as an assistive device at home resulted in a therapeutic effect on unsupported grip strength and hand function. The glove use time also showed that this wearable, lightweight glove was able to assist participants with the performance of daily tasks for prolonged periods.

Two-Year Results of a Five-Year Personalized Integrative Obesity Coaching Program (IBO) Based upon a Systems Health Perspective and an Evolutionary Longitudinal Study Approach.

This study presents the outcomes of a 5-year personalized integrative coaching program for adults with obesity (body mass index BMI ≥ 30 kg/m2), based upon a systems health perspective, during the first 2 years. This longitudinal study, which had an evolutionary design, included all adults who enrolled in the program. Health-related quality of life (HRQoL) was measured with the Short Form-36 (SF-36), and physical outcomes included weight, waist circumference, aerobic capacity, lipid profile, and HbA1c. Subsequently, participants completed questionnaires (e.g., the Symptom Checlist-90 (SCL-90) and the Checklist Individual Strength (CIS)). Seventy-nine adults with a mean BMI of 39.5 kg/m2 (SD 5.3) were included. Forty-four participants completed 2 years in the program. Compared to baseline, there were significant improvements in the SF-36 subscales 'physical functioning' (MD 9.9 points, 95% CI: 2.1-17.5, p = 0.013) and 'general health perceptions' (MD 9.3 points, 95% CI 2.9-15.7, p = 0.006). Furthermore, significant improvements in physical outcomes and psychosocial questionnaires (e.g., weight loss (MD 3.5 kg, 95% CI: 1.2-5.7, p = 0.003), waist circumference (MD 5.1 cm, 95% CI: 2.4-7.8, p < 0.001), and CIS fatigue (MD 6.8, 95% CI: 3.1-10.5, p = 0.001) were observed. This study highlights the importance of a systems health perspective supporting the development of a personalized integrative coaching program for adults with obesity in a 'real-world' setting.

Total joint arthroplasty versus trapeziectomy in the treatment of trapeziometacarpal joint arthritis: a randomized controlled trial.

The aim of this double anonymized, randomized controlled trial was to determine whether total joint arthroplasty has superior outcomes than trapeziectomy 1 year after surgery for trapeziometacarpal osteoarthritis. A total of 62 women aged 40 years and older, scheduled for surgery for stage II or III osteoarthritis of the trapeziometacarpal joint, were included and randomized to trapeziectomy or total joint arthroplasty. The primary outcome was the total score of the Michigan Hand Outcomes Questionnaire. Secondary outcomes were the Michigan Hand Outcomes Questionnaire subscale scores, Disability of the Arm, Shoulder and Hand Questionnaire, active range of motion, strength, return to work, patient satisfaction and complications. Data were collected at baseline and at 3 and 12 months. At 1 year, we found no superiority of total joint arthroplasty over trapeziectomy regarding the total score of the Michigan Hand Outcomes Questionnaire. The total joint arthroplasty did show a significant advantage in strength and range of motion.Level of evidence: I.

Effect on Hand Function After Six-week Use of a Wearable Soft-Robotic Glove Assisting ADL: Interim Results of an Ongoing Clinical Study.

In an ongoing study, an assistive wearable soft-robotic glove is tested at home for 6 weeks by subjects with decreased handgrip strength, due to different hand injuries or diseases, to assess whether use of this assistive grip-supporting glove will result in improved hand strength/ function. An interim analysis of the available dataset of 46 participants showed that (unsupported) grip strength and hand function improved after using the soft-robotic glove as assistive aid during activities of daily living (ADLs) during 6 weeks at home. After glove use is ended, this is maintained for at least 4 weeks. Considering that in the current situation the analysis is underpowered, these interim results are promising for finding a clinical (therapeutic) effect of using a soft-robotic glove as assistance during ADLs. If this is the case, this might open up entirely new opportunities for extending rehabilitation into people's homes, while also providing them with assistance to directly support performance of daily activities. Such a combination is becoming available with the development of mature and user-friendly wearable soft-robotic devices. This would enable very high doses of training throughout the day, in the most functional, task-specific way possible, and possibly prevention of learned non-use.

Therapeutic Effect of a Soft Robotic Glove for Activities of Daily Living In People With Impaired Hand Strength: Protocol for a Multicenter Clinical Trial (iHand).

BACKGROUND: Decline of hand function, especially reduced hand strength, is a common problem that can be caused by many disorders and results in difficulties performing activities of daily living. A wearable soft robotic glove may be a solution, enabling use of the affected arm and hand repeatedly during functional daily activities and providing intensive and task-specific training simultaneously with assistance of hand function. OBJECTIVE: We aim to investigate the therapeutic effect of an assistive soft robotic glove (Carbonhand). METHODS: This multicenter uncontrolled intervention study consists of 3 preassessments (T0, T1, and T2), a postassessment (T3), and a follow-up assessment (T4). Participants are patients who experience hand function limitations. For the intervention, participants will use the glove during activities of daily living at home for 6 weeks, with a recommended use of at least 180 minutes per week. The primary outcome measure is handgrip strength, and secondary outcome measures are related to functional arm and hand abilities, amount of glove use, and quality of life. RESULTS: The first participant was included on June 25, 2019. Currently, the study has been extended due to the COVID-19 pandemic; data collection and analysis are expected to be completed in 2022. CONCLUSIONS: The Carbonhand system is a wearable assistive device, allowing performance of functional activities to be enhanced directly during functional daily activities. At the same time, active movement of the user is encouraged as much as possible, which has potential to provide highly intensive and task-specific training. As such, it is one of the first assistive devices to incorporate assist-as-needed principles. This is the first powered clinical trial that investigates the unique application of an assistive grip-supporting soft robotic glove outside of clinical settings with the aim to have a therapeutic effect. TRIAL REGISTRATION: Netherlands Trial Register NTR NL7561; https://www.trialregister.nl/trial/7561. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34200.

Developing a Personalized Integrative Obesity-Coaching Program: A Systems Health Perspective.

Current obesity management strategies are failing to achieve sustainable and favorable long-term results. We propose a more personalized, dynamic, and systemic perspective on the interactions of key determinants and coaching advice on obesity. The aim of this study was to use a systems view on overweight, complexity science, and a transdisciplinary process to develop a five-year personalized integrative obesity-coaching and research program. Managers, medical specialists, clinical psychologists, dieticians, physical- and psychomotor therapists, and lifestyle coaches aligned their perspectives and objectives with experts in systems thinking and systems biology. A systems health model of obesity was used to identify the causal relations of variables with the most influence on obesity. The model helped to align and design a personalized integrative obesity-coaching program and to identify the key variables to monitor the progress and to adjust the personalized program, depending on the goals and needs of the participant. It was decided to use subtyping of participants by a systems biologist, based on traditional Chinese medicine symptoms, as a novel method to personalize the intervention. The collaborative transdisciplinary approach based upon a systems view on obesity was successful in developing a personalized and adaptive five-year obesity-coaching and research program.

Radiographic goniometry of the PIP-joint: A reliable measurement method.

INTRODUCTION: Arthrodesis of the proximal interphalangeal joint (PIP joint) is a good treatment option for relief of arthritic pain. The angle of the fused PIP joint is considered important for postoperative digital function. It is therefore important to reliably measure the actual angle of fusion. Goniometry performed by hand therapists or hand surgeons can generate measurement errors. PURPOSE OF THE STUDY: The purpose of this study is therefore to investigate the intraobserver and interobserver reliability of measuring the angle of fusion of the PIP joint on X-rays. STUDY DESIGN: A clinimetric study was conducted investigating the reliability of X-ray goniometry. METHODS: Three blinded observers measured the angle of the PIP-joint fusion on a lateral postoperative X-ray. The intraobserver and interobserver reliability was calculated. RESULTS: Ninety-four patient X-rays were measured. The intraobserver reliability showed an intraclass correlation coefficient (ICC) of 0.94, and the ICC for the interobserver reliability ranged between 0.92 and 0.95. DISCUSSION: Because this is the first reliability study on radiographic goniometry, comparison of our data with other similar studies is difficult. The best comparison can be made to in vivo goniometry. Based on the investigation of ICC values of various studies on the reliability of in vivo goniometry, radiographic goniometry seems to be more reliable. CONCLUSIONS: These results indicate an excellent reliability, which is generally higher than the reliability for in vivo goniometry of the PIP joint performed by hand therapists or hand surgeons. We can conclude that radiographic goniometry of the PIP joint is a highly reliable measurement method.