Preliminary effectiveness and production time and costs of three-dimensional printed orthoses in chronic hand conditions: an interventional feasibility study.

OBJECTIVE: To assess the preliminary effectiveness of three-dimensional printed orthoses compared with conventionally custom-fabricated orthoses in persons with chronic hand conditions on performance of daily activities, hand function, quality of life, satisfaction, and production time and costs. DESIGN: Interventional feasibility study. SUBJECTS: Chronic hand orthotic users (n = 21). METHODS: Participants received a new three-dimensional printed orthosis according to the same type as their current orthosis, which served as the control condition. Primary outcome was performance of daily activities (Patient-Reported Outcomes Measurement Information System-Upper Extremity; Michigan Hand Questionnaire). Secondary outcomes were hand function, quality of life, and satisfaction. Furthermore, production time and costs were recorded. RESULTS: At 4 months' follow-up, no significant differences were found between three-dimensional printed orthoses and participants' existing conventional orthoses on activity performance, hand function, and quality of life. Satisfaction with the three-dimensional printed orthosis was significantly higher and the production time and costs for three-dimensional printed orthoses were significantly lower compared with conventional orthoses. The three-dimensional printed orthosis was preferred by 79% of the participants. CONCLUSIONS: This feasibility study in chronic hand conditions suggests that three-dimensional printed orthoses are similar to conventional orthoses in terms of activity performance, hand function, and quality of life. Satisfaction, and production time and costs favoured the three-dimensional printed hand orthoses.

Validity and reliability of the Dutch translation of the OPUS' client satisfaction with device module in chronic users of hand orthoses.

BACKGROUND: Orthosis satisfaction is an important outcome in assessing quality of care. However, no measurement specifically assessing orthosis satisfaction is available in the Dutch language. Therefore, the aim of this study was to translate the Client Satisfaction with Device (CSD) module of the Orthotics and Prosthetics Users' Survey (OPUS) into Dutch, and to assess its content validity, structural validity and reliability in persons with chronic hand conditions. METHODS: The CSD was translated and cross-cultural adapted according to respective guidelines. To determine content validity, 10 chronic hand orthotic users and two professionals judged the relevance, comprehensibility, and comprehensiveness of the Dutch CSD (D-CSD). Thereafter, in a cross-sectional study, 76 persons were asked to complete the D-CSD twice, with a 2-week interval. Dimensionality of the D-CSD was examined by principal component analysis (PCA), and factor model fit was assessed by confirmatory factor analysis (CFA). Reliability was assessed as internal consistency and test-retest reliability, including the 95% limits of agreement (LoA), the standard error of measurement (SEM) and smallest detectable change (SDC). RESULTS: The D-CSD items and response options were deemed relevant and comprehensible. After adding an item on cleaning the orthosis, content validity was judged sufficient. PCA indicated a one-factor model, which was confirmed by CFA. We found good internal consistency (Cronbach's alpha = 0.82; 95%CI 0.75-0.87), and moderate to good test-retest reliability (ICC = 0.81; 95%CI 0.71-0.87). There was no difference between the mean D-CSD score at test (26.8 points) and retest (25.9 points) (mean (SD) difference: 0.86 points (4.00); 95%CI -0.06-1.79; p = 0.07). The 95% LoA were -6.99 to 8.71, and the SEM and SDC were 2.88 and 7.98 points, respectively. CONCLUSIONS: Based on sufficient content and structural validity, and good reliability, we consider the D-CSD a useful tool to evaluate orthosis satisfaction in persons with chronic hand conditions on group level. Because of a relatively high SDC, sensitivity to detect changes over time on individual level is limited. STUDY REGISTRATION NUMBER: NCT05320211.

Preliminary effectiveness of 3D-printed orthoses in chronic hand conditions: study protocol for a non-randomised interventional feasibility study.

INTRODUCTION: Hand orthoses are often provided to improve performance of activities of daily life (ADL). Yet, the manufacturing process of conventional custom-fabricated hand orthoses is a time-consuming and labour-intensive process. Even though three-dimensional (3D) printing of orthoses is a rapidly growing area that can facilitate the manufacturing process of hand orthoses, evidence on the effectiveness, costs and production time of 3D-printed orthoses in chronic hand conditions is scarce. This study aims to assess (1) the preliminary effectiveness of 3D-printed orthoses compared with conventionally custom-fabricated orthoses in persons with chronic hand conditions, (2) production time and costs of both orthoses and (3) experiences of the participants and orthotists with the manufacturing process of the 3D-printed orthosis. METHODS AND ANALYSIS: In this prospective non-randomised interventional feasibility study, 20 adults with various chronic hand conditions using a conventional thumb, wrist or wrist-thumb orthosis will be provided with a 3D-printed corresponding type of orthosis. Assessments will be done 2 weeks prior to the intervention and at baseline for the conventional orthosis, and at 1 month and 4 months follow-up for the 3D-printed orthosis. The primary outcome is change from baseline in ADL performance (custom short form Dutch-Flemish Patient-Reported Outcomes Measurement Information System-Upper Extremity; ADL domain Michigan Hand Outcomes Questionnaire Dutch language version (MHQ-DLV)) at 4 months follow-up. Secondary outcomes include general hand function (MHQ-DLV), satisfaction with the orthosis (Dutch Client Satisfaction with Device; Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology), usability (in-house questionnaire) and quality of life (EuroQoL 5-Dimension 5-Level). Costs and production time of the conventional and 3D-printed orthoses will be prospectively recorded. Experiences regarding the manufacturing process will be obtained from participants and orthotists (in-house questionnaire). ETHICS AND DISSEMINATION: The Medical Ethics Committee of the Amsterdam UMC, Academic Medical Centre, has waived the requirement for ethical review of this study. Results will be disseminated through peer-reviewed journals, scientific conferences, and media aimed at a broad audience including patients. TRIAL REGISTRATION NUMBER: NCT05320211.

Production Time and User Satisfaction of 3-Dimensional Printed Orthoses For Chronic Hand Conditions Compared With Conventional Orthoses: A Prospective Case Series.

OBJECTIVE: Hand orthoses are often prescribed for persons with chronic hand and wrist impairments. This study assessed the feasibility, in terms of production time and user satisfaction, of 3-dimensional printed hand orthoses compared with conventional hand orthoses for this population. METHODS: In this prospective case series, both a conventional hand orthosis and a 3-dimensional printed hand orthosis were manufactured for 10 participants. Production time (in minutes) of each orthosis was recorded. Each orthosis was worn for one week, after which participants completed a self-designed questionnaire on satisfaction, scored on a 5-point Likert scale. Functionality and orthosis preference were also assessed. RESULTS: The mean (standard deviation (SD)) production time for the 3-dimensional printed orthoses, of 112 (11.0) min, was significantly shorter compared with 239 (29.2) min for the conventional orthoses (95% confidence interval (95% CI) 71-182 min, p = 0.001). Satisfaction scores were similar for both orthoses, except for comfort item "fitting method", which was rated significantly higher for scanning compared with casting (median [IQR] score: 5 [0.0]; 4 [2.0], p = 0.034). Functionality and orthosis preference were rated similar for both orthoses. CONCLUSION: As the production time was halved, user satisfaction similar, and scanning experienced as slightly more comfortable than casting, 3-dimensional printed hand orthoses seem feasible and potentially beneficial for use in people with chronic hand and wrist impairments.

Responsiveness of the Canadian occupational performance measure.

This study evaluated the responsiveness of the Canadian Occupational Performance Measure (COPM), an individualized, client-centered outcome measure for the identification and evaluation of self-perceived occupational performance problems. We recruited 152 consecutive patients with various diagnoses, admitted to the outpatient clinic of two occupational therapy departments, to complete a COPM interview and three self-reported health status questionnaires on two occasions: prior to the start of occupational therapy treatment and 3 months later. The three questionnaires were the Sickness Impact Profile (SIP68), the Disability and Impact Profile (DIP), and the Impact on Participation and Autonomy (IPA). We assessed criterion responsiveness by calculating the area under the curve (AUC) for the receiver operating characteristic curve and the optimal cutoff values for the COPM scores.To determine construct responsiveness, we calculated correlations between the change in COPM scores and the change in the SIP68, DIP, and IPA scores. The AUC ranged from 0.79 to 0.85, and the optimal cut-off values for the performance scores and satisfaction scores ranged from 0.9 to 1.9.We found significant positive correlations between the COPM scores and the SIP68, DIP, and IPA scores. The capability of the COPM to detect changes in perceived occupational performance issues is supported.

Sensory re-education after nerve injury of the upper limb: a systematic review.

OBJECTIVE: To systematically review the available evidence for the effectiveness of sensory re-education to improve the sensibility of the hand in patients with a peripheral nerve injury of the upper limb. DATA SOURCES: Studies were identified by an electronic search in the databases MEDLINE, Cumulative Index to Nursing & Allied Health Literature (CINAHL), EMBASE, the Cochrane Library, the Physiotherapy Evidence Database (PEDro), and the database of the Dutch National Institute of Allied Health Professions (Doconline) and by screening the reference lists of relevant articles. REVIEW METHODS: Two reviewers selected studies that met the following inclusion criteria: all designs except case reports, adults with impaired sensibility of the hand due to a peripheral nerve injury of the upper limb, and sensibility and functional sensibility as outcome measures. The methodological quality of the included studies was independently assessed by two reviewers. A best-evidence synthesis was performed, based on design, methodological quality and significant findings on outcome measures. RESULTS: Seven studies, with sample sizes ranging from 11 to 49, were included in the systematic review and appraised for content. Five of these studies were of poor methodological quality. One uncontrolled study (N = 1 3 ) was considered to be of sufficient methodological quality, and one randomized controlled trial (N = 49) was of high methodological quality. Best-evidence synthesis showed that there is limited evidence for the effectiveness of sensory re-education, provided by a statistically significant improvement in sensibility found in one high-quality randomized controlled trial. CONCLUSION: There is a need for further well-defined clinical trials to assess the effectiveness of sensory re-education of patients with impaired sensibility of the hand due to a peripheral nerve injury.