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- Ludvigsson, Johnny, et al.
(författare)
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GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus
- 2012
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Ingår i: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 366:5, s. 433-442
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The 65-kD isoform of glutamic acid decarboxylase (GAD65) is a major autoantigen in type 1 diabetes. We hypothesized that alum-formulated GAD65 (GAD-alum) can preserve beta-cell function in patients with recent-onset type 1 diabetes.METHODS: We studied 334 patients, 10 to 20 years of age, with type 1 diabetes, fasting C-peptide levels of more than 0.3 ng per milliliter (0.1 nmol per liter), and detectable serum GAD65 autoantibodies. Within 3 months after diagnosis, patients were randomly assigned to receive one of three study treatments: four doses of GAD-alum, two doses of GAD-alum followed by two doses of placebo, or four doses of placebo. The primary outcome was the change in the stimulated serum C-peptide level (after a mixed-meal tolerance test) between the baseline visit and the 15-month visit. Secondary outcomes included the glycated hemoglobin level, mean daily insulin dose, rate of hypoglycemia, and fasting and maximum stimulated C-peptide levels.RESULTS: The stimulated C-peptide level declined to a similar degree in all study groups, and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group (P=0.10). The use of GAD-alum as compared with placebo did not affect the insulin dose, glycated hemoglobin level, or hypoglycemia rate. Adverse events were infrequent and mild in the three groups, with no significant differences.CONCLUSIONS: Treatment with GAD-alum did not significantly reduce the loss of stimulated C peptide or improve clinical outcomes over a 15-month period.
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| 4. |
- Lendaro, Eva, et al.
(författare)
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Extended reality used in the treatment of phantom limb pain : a multicenter, double-blind, randomized controlled trial
- 2024
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Ingår i: Pain. - 0304-3959 .- 1872-6623.
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Tidskriftsartikel (refereegranskat)abstract
- Phantom limb pain (PLP) represents a significant challenge after amputation. This study investigated the use of phantom motor execution (PME) and phantom motor imagery (PMI) facilitated by extended reality (XR) for the treatment of PLP. Both treatments used XR, but PME involved overt execution of phantom movements, relying on the decoding of motor intent using machine learning to enable real-time control in XR. In contrast, PMI involved mental rehearsal of phantom movements guided by XR. The study hypothesized that PME would be superior to PMI. A multicenter, double-blind, randomized controlled trial was conducted in 9 outpatient clinics across 7 countries. Eighty-one participants with PLP were randomly assigned to PME or PMI training. The primary outcome was the change in PLP, measured by the Pain Rating Index, from baseline to treatment cessation. Secondary outcomes included various aspects related to PLP, such as the rate of clinically meaningful reduction in pain (CMRP; >50% pain decrease). No evidence was found for superiority of overt execution (PME) over imagery (PMI) using XR. PLP decreased by 64.5% and 68.2% in PME and PMI groups, respectively. Thirty-seven PME participants (71%) and 19 PMI participants (68%) experienced CMRP. Positive changes were recorded in all other outcomes, without group differences. Pain reduction for PME was larger than previously reported. Despite our initial hypothesis not being confirmed, PME and PMI, aided by XR, are likely to offer meaningful PLP relief to most patients. These findings merit consideration of these therapies as viable treatment options and alternatives to pharmacological treatments.
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| 6. |
- Leonardi, Matilde, et al.
(författare)
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Integrating research into policy planning : MHADIE policy recommendations
- 2010
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Ingår i: Disability and Rehabilitation. - : Informa UK Limited. - 0963-8288 .- 1464-5165. ; 32:S1, s. 139-147
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Tidskriftsartikel (refereegranskat)abstract
- MHADIE project (Measuring Health and Disability in Europe: Supporting policy development) aimed at developing realistic, evidence-based and effective national policies for persons with disabilities. A preliminary step towards this goal was the demonstration on the feasibility of employing the ICF in clinical, educational and statistical fields, which corresponds to the recognised need to enhance the European Union's capacity of analysis of disability, as highlighted in its Disability Action Plan 2006–2007. The ultimate outcome of the project is the production of 13 policy recommendations, dealing with statistics clinical and educational areas, and four general policy recommendations focusing on: (a) the need of coordinating and integrating disability conceptualisation at all policy levels and across sectors; (b) the need of conducing longitudinal cohort studies which include children aged 0–6; (c) the need of reviewing transportation policies in light of the requirements of persons with disabilities; (d) the need of reviewing all disability policies to emphasise and support the role of the family, which is a consistent and substantial environmental facilitator in the lives of persons with disabilities.
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| 7. |
- Lindner, Helen, 1967-
(författare)
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The Assessment of Capacity for Myoelectric Control : Psychometric evidence and comparison with upper limb prosthetic outcome measures
- 2013
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Evaluation of outcomes using validated prosthetic outcome measures (OMs) is a current priority in upper limb (UL) prosthetics, and OMs with psychometric evidence toward UL prosthesis users are thus necessary. The “Assessment of Capacity for Myoelectric Control” (ACMC) is a tool that assesses the ability to control a myoelectric prosthetic hand. Some psychometric aspects of the ACMC have been previously investigated, but others are still lacking. A major part of this thesis was thus to search and assess the psychometric evidence of the ACMC. Data were collected from prosthesis users of different ages, prosthetic sides, and sexes. Rasch analysis was used to search for validity evidence and activity influence on the users’ ACMC ability measures, while reliability statistics was used to search for reliability evidence. Overall, the validity evidence was satisfactory in terms of unidimensionality, item technical quality, item difficulty, and relation to prosthetic wearing time. In terms of activity influence, the majority of prosthesis users received similar ability measures in different activities. Reliability evidence was also satisfactory in terms of test-retest reliability and rater agreements (intra- and interrater).Besides the ACMC, several other prosthetic OMs have been developed in recent years. A comparison of these OMs would help professionals to select appropriate tools for clinical practice. Thus, a comparison of the validated UL prosthetic OMs was performed with an emphasis on what health aspects they cover. Eight OMs were chosen, and their contents were linked to the “International Classification of Functioning, Disability and Health” (ICF). The results showed that the contents from different OMs were linked to the ICF categories in “Body functions,” “Activity and Participation,” and “Environmental Factors.”In conclusion, the use of a mixture of OMs is recommended to cover different aspects of health. Based on the evidence in this thesis, the ACMC can be recommended to measure the ability to control a myoelectric hand.
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| 8. |
- Mlakar, Maja, et al.
(författare)
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Effect of custom-made and prefabricated orthoses on grip strength in persons with carpal tunnel syndrome
- 2014
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Ingår i: Prosthetics and Orthotics International. - : Ovid Technologies (Wolters Kluwer Health). - 0309-3646 .- 1746-1553. ; 38:3, s. 193-198
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Tidskriftsartikel (refereegranskat)abstract
- Background: Based on the literature, patients with carpal tunnel syndrome are suggested to wear a custom-made wrist orthosis immobilizing the wrist in a neutral position. Many prefabricated orthoses are available on the market, but the majority of those do not assure neutral wrist position. Objectives: We hypothesized that the use of orthosis affects grip strength in persons with carpal tunnel syndrome in a way that supports preference for custom-made orthoses with neutral wrist position over prefabricated orthoses. Study design: Experimental. Methods: Comparisons of grip strength for three types of grips (cylindrical, lateral, and pinch) were made across orthosis types (custom-made, prefabricated with wrist in 20 degrees of flexion, and none) on the affected side immediately after fitting, as well as between affected side without orthosis and nonaffected side. Results: Orthosis type did not significantly affect grip strength (p = 0.661). Cylindrical grip was by far the strongest, followed by lateral and pinch grips (p < 0.050). The grips of the affected side were weaker than those of the nonaffected side (p = 0.002). Conclusions: In persons with carpal tunnel syndrome, neither prefabricated orthoses with 20 degrees wrist extension nor custom-made wrist orthoses with neutral wrist position influenced grip strength of the affected hand. Compared to the nonaffected side, the grips of the affected side were weaker. Clinical relevance The findings from this study can be used to guide application of orthoses to patients with carpal tunnel syndrome.
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| 9. |
- Ortiz-Catalan, Max, et al.
(författare)
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Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain : a single group, clinical trial in patients with chronic intractable phantom limb pain
- 2016
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Ingår i: The Lancet. - : Elsevier. - 0140-6736 .- 1474-547X. ; 388:10062, s. 2885-2894
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Tidskriftsartikel (refereegranskat)abstract
- Background: Phantom limb pain is a debilitating condition for which no eff ective treatment has been found. We hypothesised that re-engagement of central and peripheral circuitry involved in motor execution could reduce phantom limb pain via competitive plasticity and reversal of cortical reorganisation.Methods: Patients with upper limb amputation and known chronic intractable phantom limb pain were recruited at three clinics in Sweden and one in Slovenia. Patients received 12 sessions of phantom motor execution using machine learning, augmented and virtual reality, and serious gaming. Changes in intensity, frequency, duration, quality, and intrusion of phantom limb pain were assessed by the use of the numeric rating scale, the pain rating index, the weighted pain distribution scale, and a study-specifi c frequency scale before each session and at follow-up interviews 1, 3, and 6 months after the last session. Changes in medication and prostheses were also monitored. Results are reported using descriptive statistics and analysed by non-parametric tests. The trial is registered at ClinicalTrials. gov, number NCT02281539.Findings: Between Sept 15, 2014, and April 10, 2015, 14 patients with intractable chronic phantom limb pain, for whom conventional treatments failed, were enrolled. After 12 sessions, patients showed statistically and clinically signifi cant improvements in all metrics of phantom limb pain. Phantom limb pain decreased from pre-treatment to the last treatment session by 47% (SD 39; absolute mean change 1 . 0 [0 . 8]; p= 0 . 001) for weighted pain distribution, 32% (38; absolute mean change 1 . 6 [1 . 8]; p= 0 . 007) for the numeric rating scale, and 51% (33; absolute mean change 9 . 6 [8 . 1]; p= 0 . 0001) for the pain rating index. The numeric rating scale score for intrusion of phantom limb pain in activities of daily living and sleep was reduced by 43% (SD 37; absolute mean change 2 . 4 [2 . 3]; p= 0 . 004) and 61% (39; absolute mean change 2 . 3 [1 . 8]; p= 0 . 001), respectively. Two of four patients who were on medication reduced their intake by 81% (absolute reduction 1300 mg, gabapentin) and 33% (absolute reduction 75 mg, pregabalin). Improvements remained 6 months after the last treatment.Interpretation: Our fi ndings suggest potential value in motor execution of the phantom limb as a treatment for phantom limb pain. Promotion of phantom motor execution aided by machine learning, augmented and virtual reality, and gaming is a non-invasive, non-pharmacological, and engaging treatment with no identifi ed side-eff ects at present.
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| 10. |
- Postema, Sietke G., et al.
(författare)
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Musculoskeletal Complaints in Transverse Upper Limb Reduction Deficiency and Amputation in The Netherlands : Prevalence, Predictors, and Effect on Health
- 2016
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Ingår i: Archives of Physical Medicine and Rehabilitation. - Philadelphia, USA : Saunders Elsevier. - 0003-9993 .- 1532-821X. ; 97:7, s. 1137-1145
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Tidskriftsartikel (refereegranskat)abstract
- Objective: (1) To determine the prevalence of musculoskeletal complaints (MSCs) in individuals with upper limb absence in The Netherlands, (2) to assess the health status of individuals with upper limb absence in general and in relation to the presence of MSCs, and (3) to explore the predictors of development of MSCs and MSC-related disability in this population.Design: Cross-sectional study: national survey.Setting: Twelve rehabilitation centers and orthopedic workshops.Partiscipants: Individuals (n=263; mean age, 50.7±16.7y; 60% men) ≥18 years old, with transverse upper limb reduction deficiency (42%) or amputation (58%) at or proximal to the carpal level (response, 45%) and 108 individuals without upper limb reduction deficiency or amputation (n=108; mean age, 50.6±15.7y; 65% men) (N=371).Interventions: Not applicable.Main outcome measures: Point and year prevalence of MSCs, MSC-related disability (Pain Disability Index), and general health perception and mental health (RAND-36 subscales).Results: Point and year prevalence of MSCs were almost twice as high in individuals with upper limb absence (57% and 65%, respectively) compared with individuals without upper limb absence (27% and 34%, respectively) and were most often located in the nonaffected limb and upper back/neck. MSCs were associated with decreased general health perception and mental health and higher perceived upper extremity work demands. Prosthesis use was not related to presence of MSCs. Clinically relevant predictors of MSCs were middle age, being divorced/widowed, and lower mental health. Individuals with upper limb absence experienced more MSC-related disability than individuals without upper limb absence. Higher age, more pain, lower general and mental health, and not using a prosthesis were related to higher disability.Conclusions: Presence of MSCs is a frequent problem in individuals with upper limb absence and is associated with decreased general and mental health. Mental health and physical work demands should be taken into account when assessing such a patient. Clinicians should note that MSC-related disability increases with age.
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