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Abstract Background The main aim of this paper is to present the feasibility of rigorously designed multiple N-of-1 design in prosthetics research. While research of adequate power and high quality is often lacking in rehabilitation, N-of-1 trials can offer a feasible alternative to randomized controlled group trials, both increasing design power at group level and allowing a rigorous, statistically confirmed evaluation of effectiveness at a single patient level. The paper presents a multiple N-of-1 trial protocol, which aim is to evaluate the effectiveness of Unity, a prosthetic add-on suspension system for amputees, on patient-reported comfort during daily activities (main outcome measure), prosthesis wearing time, perception of limb-prosthesis fitting and stump volume and functional walking parameters. Methods Multicenter, randomized, prospective, double-blind multiple N-of-1 trial using an introduction/withdrawal design alternating Unity connected/disconnected phases of randomized length on twenty patients with unilateral transtibial amputation. The primary outcome measure is the Prosthetic Socket Comfort Score (SCS), a validated measure of comfort, administered daily by an phone app designed for the study. Secondary outcomes measures will be collected during the 50 days period of the N-of-1 trial: (1) by the same app, daily for patient-reported limb-prosthesis fitting, stump volume variation, and daily wearing time of the prosthesis; (2) by a pedometer for the number of steps per day; (3) by blind assessors in the rehabilitation center during adjustment visits for functional walking parameter (L-Test, 6-minute walk test), and by the patient for the QUEST, and ABC-S. Effectiveness of the Unity system regarding SCS and daily secondary outcome measures will be tested by randomization test. The secondary outcome measures assessed during visits in the rehabilitation center will be analyzed by Non Overlap of All pairs. An estimate of the effect on the amputee population will be generated by aggregating each individual clinical trial (N-of-1 trial) by Hierarchical Bayesian methods. Discussion This study protocol was designed to answer the question “which device is best for THIS patient" and to conclude at a group level on the effectiveness of a new devic, using a Multiple N-of-1 trial, which is promising but underused in prosthetics research so far. Trial registration N° ID-RCB 2020-A01309-30 Clintrial.gov : NCT04804150 - Retrospectively registered March 20th 2021.

IntroductionExposure to public stigma can lead to the internalization of autism-related stigma (i.e., self-stigma), associated with negative health, occupational and social outcomes. Importantly, self-stigma is linked to shame and social isolation. Although elevated self-stigma has been reported in autistic adults, to the best of our knowledge, interventions designed to target this issue are lacking. Compassion is an effective way to reduce the emotional correlates of self-stigma (i.e., shame) and their impacts on mental health. However, no study has investigated whether compassion focused therapy (CFT) can effectively reduce self-stigma in autistic adults. The present study aims at investigating whether and how self-compassion improvement following CFT may reduce self-stigma and shame in an autistic individual.MethodsA single case pre-experimental design (SCED) was used with weekly repeated measures during four phases: (i) pure baseline without any intervention (A), (ii) case conceptualization (A’), (iii) intervention (B) where CFT was delivered, (iv) follow-up without intervention (FU). The participant is a 46-year-old autistic man with high self-stigma and shame. Self-report measures of self-compassion and self-stigma and a daily idiographic measure of shame were used.ResultsThere was a large increase in self-compassion between pure baseline (A) and the intervention phase (A’B) (Tau-U = 0.99), maintained at follow-up. Similarly, there was a moderate decrease of self-stigma (Tau-U = 0.32). In contrast, when we compared the whole baseline phase AA’ (i.e., considering the conceptualisation phase as baseline) to the intervention (B), there was no change in self-stigma (Tau-U = −0.09). There was no change in self-stigma between the intervention (B) and follow-up (Tau-U = −0.19). There was a moderate decrease in daily shame reports between the baseline (AA’) and the intervention (B) (Tau-U = 0.31) and a moderate decrease between the pure baseline (A) and intervention phase (A’B) (Tau-U = 0.51).ConclusionCFT was feasible for this autistic client and our results show that CFT led to the improvement of self-compassion. Changes on self-stigma measures were moderate. Self-stigma may need more time to change. Because self-stigma is involved in poorer social functioning and mental health in autistic adults, our results are promising and suggesting conducting more large-scale studies on CFT in autistic adults.

Context: Goal Attainment Scaling (GAS) is a person-centered and collaborative approach, allowing to assess the effectiveness of an intervention on personally relevant goals. However, GAS is not a “scale” but a heterogeneous group of methodologies, including many variations and lack of consensus on high quality GAS. Objective: The aim of this communication is to: 1. provide updated didactical information on GAS use in PRM practice and research; 2. increase awareness of GAS methodological challenges; 3. guide use of GAS as an integrated process of rehabilitation after goal setting and; 4. provide updated resources for self-directed learning and extensive supplemental material to increase knowledge and practical skills in GAS use. Methods: Educational literature review about current GAS applications relevant to PRM fields. Results: Practical advice is provided regarding clinical challenges in GAS: definition of 0 level, time-frame and means employed to attain the goal, dealing with unforeseen pattern of improvement, synthesizing the numerous significations of “SMART” goal acronym to guide best use of GAS, and thinking flexibility on the type of relevant goals that can be set. Challenges with GAS in rehabilitation research are presented in order to promote researcher’s and reviewer’s awareness on reliable use of GAS and encouraging best-use of GAS. LAY ABSTRACT The goal attainment scaling methodology is a relevant way of measuring the effectiveness of a treatment, by creating scales to measure whether the goals previously identified with the person have been achieved through the treatment. There are many goal attainment scaling methodological variants, with a significant impact on results, of which users are not always aware. The aims of this review of the literature regarding current applications of goal attainment scaling in Physical and Rehabilitation Medicine fields, are to (i) provide up-to-date didactic information on the use of goal attainment scaling in Physical and Rehabilitation Medicine practice and research; (ii) raise awareness of the methodological challenges of goal attainment scaling; (iii) guide the use of goal attainment scaling to support the rehabilitation process after goal setting; and (iv) provide up-to-date resources for self-directed training. Practical guidelines are provided for the use of goal attainment scaling in clinical practice, and the challenges of use of this methodology in rehabilitation research are presented in order to educate researchers and evaluators on the reliable use of goal attainment scaling.

ObjectivesTo perform a detailed description of executive functioning following moderate-to-severe childhood traumatic brain injury (TBI), and to study demographic and severity factors influencing outcome.MethodsA convenience sample of children/adolescents aged 7–16 years, referred to a rehabilitation department after a TBI (n = 43), was compared to normative data using a newly developed neuropsychological test battery (Child Executive Functions Battery—CEF-B) and the BRIEF.ResultsPerformance in the TBI group was significantly impaired in most of the CEF-B subtests, with moderate to large effect sizes. Regarding everyday life, patients were significantly impaired in most BRIEF clinical scales, either in parent or in teacher reports. Univariate correlations in the TBI group did not yield significant correlations between the CEF-B and socio-economic status, TBI severity, age at injury, or time since injury.ConclusionExecutive functioning is severely altered following moderate-to-severe childhood TBI and is best assessed using a combination of developmentally appropriate neuropsychological tests and behavioral ratings to provide a comprehensive understanding of children’s executive functions.