| 1. |
- Eliasson, Ann-Christin, et al.
(författare)
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Efficacy of the small step program in a randomised controlled trial for infants below age 12 months with clinical signs of CP; a study protocol
- 2016
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Ingår i: BMC Pediatrics. - London : Springer Science and Business Media LLC. - 1471-2431 .- 1471-2431. ; 16
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Tidskriftsartikel (refereegranskat)abstract
- Background: Children with cerebral palsy (CP) have life-long motor disorders, and they are typically subjected to extensive treatment throughout their childhood. Despite this, there is a lack of evidence supporting the effectiveness of early interventions aiming at improving motor function, activity, and participation in daily life. The study will evaluate the effectiveness of the newly developed Small Step Program, which is introduced to children at risk of developing CP during their first year of life. The intervention is based upon theories of early learning-induced brain plasticity and comprises important components of evidence-based intervention approaches used with older children with CP.Method and design: A two-group randomised control trial will be conducted. Invited infants at risk of developing CP due to a neonatal event affecting the brain will be randomised to either the Small Step Program or to usual care. They will be recruited from Astrid Lindgren Children's Hospital at regular check-up and included at age 3-8 months. The Small Step Program was designed to provide individualized, goal directed, and intensive intervention focusing on hand use, mobility, and communication in the child's own home environment and carried out by their parents who have been trained and coached by therapists. The primary endpoint will be approximately 35 weeks after the start of the intervention, and the secondary endpoint will be at 2 years of age. The primary outcome measure will be the Peabody Developmental Motor Scale (second edition). Secondary assessments will measure and describe the children's general and specific development and brain pathology. In addition, the parents' perspective of the program will be evaluated. General linear models will be used to compare outcomes between groups.Discussion: This paper presents the background and rationale for developing the Small-Step Program and the design and protocol of a randomized controlled trial. The aim of the Small Step Program is to influence development by enabling children to function on a higher level than if not treated by the program and to evaluate whether the program will affect parent's ability to cope with stress and anxiety related to having a child at risk of developing CP.
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| 2. |
- Holmström, Linda, et al.
(författare)
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Efficacy of the Small Step Program in a Randomized Controlled Trial for Infants under 12 Months Old at Risk of Cerebral Palsy (CP) and Other Neurological Disorders
- 2019
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Ingår i: Journal of Clinical Medicine. - : MDPI. - 2077-0383. ; 8:7
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Tidskriftsartikel (refereegranskat)abstract
- The objective was to evaluate the effects of the Small Step Program on general development in children at risk of cerebral palsy (CP) or other neurodevelopmental disorders. A randomized controlled trial compared Small Step with Standard Care in infants recruited at 4-9 months of corrected age (CA). The 35-week intervention targeted mobility, hand use, and communication during distinct periods. The Peabody Developmental Motor Scales2ed (PDMS-2) was the primary outcome measure. For statistical analysis, a general linear model used PDMS-2 as the main outcome variable, together with a set of independent variables. Thirty-nine infants were randomized to Small Step (n = 19, age 6.3 months CA (1.62 SD)) or Standard Care (n = 20, age 6.7 months CA (1.96 SD)). Administering PDMS-2 at end of treatment identified no group effect, but an interaction between group and PDMS-2 at baseline was found (p < 0.02). Development was associated with baseline assessments in the Standard Care group, while infants in the Small Step group developed independent of the baseline level, implying that Small Step helped the most affected children to catch up by the end of treatment. This result was sustained at 2 years of age for PDMS-2 and the PEDI mobility scale.
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| 3. |
- Jacobson, Dan N O, et al.
(författare)
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A First Clinical Trial on Botulinum Toxin-A for Chronic Muscle-Related Pain in Cerebral Palsy
- 2021
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Ingår i: Frontiers in Neurology. - : Frontiers Media S.A.. - 1664-2295. ; 12
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To test if botulinum toxin-A (BoNT-A) is effective in reducing chronic muscle-related pain in adults with spastic cerebral palsy (CP), as compared to placebo.Design: A single-center, double-blind, parallel, randomized placebo-controlled trial. The design included an interim analysis to allow for confirmatory analysis, as well as pilot study outcomes.Setting: Tertiary university hospital.Participants: Adults with spastic CP and chronic pain associated with spastic muscle(s).Intervention: Treatment was one session of electromyographically guided intramuscular injections of either BoNT-A or placebo normosaline.Main Study Outcomes: The primary outcome was the proportion who achieved a reduction of pain intensity of two or more steps on the Numerical Rating Scale 6 weeks after treatment.Results: Fifty individuals were screened for eligibility, of whom 16 were included (10 female, 6 male, mean age = 32 years, SD = 13.3 years). The randomization yielded eight participants per treatment arm, and all completed the study as randomized. The study was stopped at the interim analysis due to a low probability, under a preset threshold, of a positive primary outcome. Four individuals were treatment responders in the BoNT-A group for the primary outcome compared to five responders in the placebo group (p = 1.000). Adverse events were mild to moderate. In exploratory analysis, the BoNT-A group had a trend of continuing reduction of pain at the last follow-up, after the primary endpoint.Conclusions: This study did not find evidence that BoNT-A was superior to placebo at the desired effect size (number needed to treat of 2.5) at 6 weeks after treatment. Trial registration: ClinicalTrials.gov: NCT02434549
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| 4. |
- Jacobson, Dan N O, et al.
(författare)
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Health-related quality of life, pain, and fatigue in young adults with cerebral palsy
- 2020
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Ingår i: Developmental Medicine & Child Neurology. - : Wiley. - 0012-1622 .- 1469-8749. ; 62:3, s. 372-378
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Tidskriftsartikel (refereegranskat)abstract
- AIM: To describe health-related quality of life (HRQoL), pain, fatigue, and other health variables in young adults with cerebral palsy (CP), and to explore associations with the Gross Motor Function Classification System - Expanded and Revised (GMFCS-ER) and physical activity.METHOD: This was a cross-sectional study of 61 young adults at a mean age of 21 years 2 months (standard deviation 8mo, range 20-22y) with CP, from a geographically defined area. Data collection included: Short Form 36 version 2 for HRQoL, Brief Pain Inventory - Short Form, Fatigue Severity Scale, level of physical activity, medical history, and physical examination.RESULTS: Overall HRQoL equalled that of population norms; however self-reported physical health was lower in GMFCS-ER levels III to V compared to GMFCS-ER levels I to II. Self-reported mental health was, inversely, lower in GMFCS-ER levels I to II compared to GMFCS-ER levels III to V. Pain prevalence was 49%, and pain was present across all GMFCS-ER levels. Fatigue, as well as sleep problems, had 41% prevalence, with fatigue severity decreasing with increasing level of physical activity.INTERPRETATION: General HRQoL in young adults with CP was comparable to population norms. Pain and fatigue are important to address in high motor-functioning individuals also. Physical activity could be a possible protective factor against fatigue.WHAT THIS PAPER ADDS:Health-related quality of life in young adults with cerebral palsy (CP) was comparable to population norms.Pain, fatigue, and sleep problems occurred at all Gross Motor Function Classification System levels.There is a possible protective effect of physical activity on fatigue.
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| 5. |
- Andersson, Peter, et al.
(författare)
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Anorexia Nervosa With Comorbid Severe Depression : A Systematic Scoping Review of Brain Stimulation Treatments
- 2023
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Ingår i: Journal of ECT. - : Lippincott Williams & Wilkins. - 1095-0680 .- 1533-4112. ; 39:4, s. 227-234
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Tidskriftsartikel (refereegranskat)abstract
- Major depressive disorder (MDD) is highly prevalent in individuals with anorexia nervosa (AN) and is a predictor of greater clinical severity. However, there is a limited amount of evidence supporting the use of psychotropic medications for its management. A systematic scoping review was conducted to assess the current literature on brain stimulation treatments for AN with comorbid MDD, with a specific focus on MDD treatment response and weight restoration. This review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and the PubMed, PsycInfo, and MEDLINE databases were searched until July 2022 using specific key words related to AN and brain stimulation treatments. A total of 373 citations were identified, and 49 treatment studies that met the inclusion criteria were included in the review. The initial evidence suggests that electroconvulsive therapy, repetitive transcranial magnetic stimulation, and deep-brain stimulation may be effective in managing comorbid MDD in AN. Emerging evidence suggests that transcranial direct current stimulation may have a positive effect on body mass index in individuals with severe to extreme AN. However, there is a need for the development of better measurement techniques for assessing the severity of depression in the context of AN. Controlled trials that are adequately designed to account for these limitations are highly warranted for deep-brain stimulation, electroconvulsive therapy, and repetitive transcranial magnetic stimulation and hold promise for providing clinically meaningful results.
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| 6. |
- Andersson, Peter, et al.
(författare)
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Mapping length of inpatient treatment duration and year-wise relapse rates in eating disordered populations in a well-defined Western-European healthcare region across 1998–2020
- 2023
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Ingår i: International Journal of Methods in Psychiatric Research. - : John Wiley & Sons. - 1049-8931 .- 1557-0657. ; 32:4
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Updated international guideline recommendations for AN inpatient care rely on expert opinions/observational evidence and promote extended inpatient stays, warranting investigation using higher-level ecological evidence.Methods: The study was conducted according to Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER). Data encompassing 13,885 ED inpatients (5336 adolescents and 8549 adults) was retrieved from Swedish public health registries. Variables analyzed included (1) ED inpatient care opportunities, (2) unique number of ED inpatients and (3) mean length of ED-related inpatient stays in age groups 15–19 and 20–88+, across 1998–2020.Results: Mean length of inpatient stays was inversely correlated to relapse to ED-related inpatient care within the same year (p < 0.001, R-squaredadj = 0.5216 and p < 0.00001, R-squaredadj = 0.5090, in the 15–19 and 20–88+ age groups, respectively), independent of number of ED inpatients treated within a year in both age groups. Extending mean adolescent inpatient duration from 35 to 45 days was associated with a ∼30% reduction in the year-wise relapse rate.Conclusions: Mean length of ED-related inpatient treatment stays was associated with reduced relapses to inpatient care within the same year, which could be interpreted as support for recommendations to include a stabilization phase in inpatient ED treatment.
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| 7. |
- Eliasson, Ann-Christin, 1950-, et al.
(författare)
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Efficacy of baby-CIMT : study protocol for a randomised controlled trial on infants below age 12 months, with clinical signs of unilateral CP
- 2014
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Ingår i: BMC Pediatrics. - : BioMed Central. - 1471-2431 .- 1471-2431. ; 14
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Infants with unilateral brain lesions are at high risk of developing unilateral cerebral palsy (CP). Given the great plasticity of the young brain, possible interventions for infants at risk of unilateral CP deserve exploration. Constraint-induced movement therapy (CIMT) is known to be effective for older children with unilateral CP but is not systematically used for infants. The development of CIMT for infants (baby-CIMT) is described here, as is the methodology of an RCT comparing the effects on manual ability development of baby-CIMT versus baby-massage. The main hypothesis is that infants receiving baby-CIMT will develop manual ability in the involved hand faster than will infants receiving baby-massage in the first year of life.METHOD AND DESIGN: The study will be a randomised, controlled, prospective parallel-group trial. Invited infants will be to be randomised to either the baby-CIMT or the baby-massage group if they: 1) are at risk of developing unilateral CP due to a known neonatal event affecting the brain or 2) have been referred to Astrid Lindgren Children's Hospital due to asymmetric hand function. The inclusion criteria are age 3-8 months and established asymmetric hand use. Infants in both groups will receive two 6-weeks training periods separated by a 6-week pause, for 12 weeks in total of treatment. The primary outcome measure will be the new Hand Assessment for Infants (HAI) for evaluating manual ability. In addition, the Parenting Sense of Competence scale and Alberta Infant Motor Scale will be used. Clinical neuroimaging will be utilized to characterise the brain lesion type. To compare outcomes between treatment groups generalised linear models will be used.DISCUSSION: The model of early intensive intervention for hand function, baby-CIMT evaluated by the Hand Assessment for Infants (HAI) will have the potential to significantly increase our understanding of how early intervention of upper limb function in infants at risk of developing unilateral CP can be performed and measured.TRIAL REGISTRATION: SFO-V4072/2012, 05/22/2013.
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| 8. |
- Eliasson, Ann-Christin, 1950-, et al.
(författare)
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The effectiveness of Baby-CIMT in infants younger than 12 months with clinical signs of unilateral-cerebral palsy : an explorative study with randomized design
- 2018
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Ingår i: Research in Developmental Disabilities. - : Elsevier. - 0891-4222 .- 1873-3379. ; 72, s. 191-201
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Tidskriftsartikel (refereegranskat)abstract
- AIM: To explore the effectiveness of baby-CIMT (constraint-induced movement therapy) and baby-massage for improving the manual ability of infants younger than 12 months with unilateral cerebral palsy (CP).METHOD: Infants eligible for inclusion were 3-8 months old with asymmetric hand function and at high risk of developing unilateral CP. Thirty-seven infants were assigned randomly to receive baby-CIMT or baby-massage. At one year of age 31 children were diagnosed with unilateral CP, 18 (8 boys, 6.1±1.7months) of these had received baby-CIMT and 13 (8 boys, 5.0±1.6months) baby-massage. There were two 6-week training periods separated by a 6-week pause. The Hand Assessment for Infants (HAI), Assisting Hand Assessment (AHA), the Parenting Sense of Competence Scale (PSCS) and a questionnaire concerning feasibility were applied.RESULTS: There was improvement in the "Affected hand score" of HAI from median 10 (6;13 IQR) to 13 (7;17 IQR) raw score in the baby-CIMT group and from 5 (4;11 IQR) to 6 (3;12 IQR) for baby-massage with a significant between group difference (p=0.041). At 18-month of age, the median AHA score were 51 (38;72 IQR) after baby-CIMT (n=18) compared to 24 (19;43 IQR) baby-massage (n=9). The PSCS revealed an enhanced sense of competence of being a parent among fathers in the baby-CIMT group compared to fathers in the baby-massage (p=0.002). Parents considered both interventions to be feasible.CONCLUSION: Baby-CIMT appears to improve the unimanual ability of young children with unilateral CP more than massage.
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| 9. |
- Engström, Pähr, et al.
(författare)
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Botulinum toxin A does not improve cast treatment for idiopathic toe-walking - a randomized controlled trial
- 2013
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Ingår i: Journal of Bone and Joint Surgery. American volume. - 0021-9355 .- 1535-1386. ; 95:5, s. 400-407
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Tidskriftsartikel (refereegranskat)abstract
- Background: There are many treatments for idiopathic toe-walking, including casts with or without injection of botulinum toxin A. Combined treatment with casts and botulinum toxin A has become more common even though there have been few studies of its efficacy and safety problems. Our aims were to conduct a randomized controlled trial to test the hypotheses that combined treatment with casts and botulinum toxin A is more effective than casts alone in reducing toewalking by patients five to fifteen years of age, and that the treatment effect correlates with the extent of coexisting neuropsychiatric problems. Methods: All patients who had been consecutively admitted to the pediatric orthopaedics department of our institution because of idiopathic toe-walking between November 2005 and April 2010 were considered for inclusion in the study. Forty-seven children constituted the study population. The children were randomized to undergo four weeks of treatment with below-the-knee casts either as the sole intervention or to undergo the cast treatment one to two weeks after receiving injections of botulinum toxin A into the calves. Before treatment and three and twelve months after cast removal, all children underwent three-dimensional (3-D) gait analysis. The severity of the idiopathic toe-walking was classified on the basis of the gait analysis, and the parents rated the time that their child spent on his/her toes during barefoot walking. Passive hip, knee, and ankle motion as well as ankle dorsiflexor strength were measured. Before treatment, all children were evaluated with a screening questionnaire for neuropsychiatric problems. Results: No differences were found in any outcome parameter between the groups before treatment or at three or twelve months after cast removal. Several gait-analysis parameters, passive ankle motion, and ankle dorsiflexor strength were improved at both three and twelve months in both groups, even though many children still demonstrated some degree of toe-walking. The treatment outcomes were not correlated with coexisting neuropsychiatric problems. Conclusion: Adding botulinum toxin-A injections prior to cast treatment for idiopathic toe-walking does not improve the outcome of cast-only treatment. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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| 10. |
- Engström, Pähr, et al.
(författare)
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Does Botulinum toxin A improve the walking pattern in children with idiopathic toe-walking?
- 2010
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Ingår i: Journal of Children's Orthopaedics. - : SAGE Publications. - 1863-2521 .- 1863-2548. ; 4:4, s. 301-308
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Tidskriftsartikel (refereegranskat)abstract
- Background: Numerous recommendations have been made for treating idiopathic toe-walking (ITW), but the treatment results have been questioned. The purpose of this study was to investigate whether botulinum toxin A (BTX) improves the walking pattern in ITW as examined with 3-D gait analysis. Participants and methods: A consecutive series of 15 children (aged 5-13 years) were enrolled in the study. The children underwent a 3-D gait analysis prior to treatment with a total of 6 units/kg bodyweight Botox® in the calf muscles and an exercise program. The gait analysis was repeated 3 weeks and 3, 6, and 12 months after treatment. A classification of toe-walking severity was made before treatment and after 12 months. The parents rated the perceived amount of toe-walking prior to treatment and 6 and 12 months after treatment. Results: Eleven children completed the 12-month follow-up. The gait analysis results displayed a significant improvement, indicating decreased plantarflexion angle at initial contact and during swing phase and increased dorsiflexion angle during midstance at all post-treatment testing instances. According to the parents' perception of toe-walking, 3/11 children followed for 12 months had ceased toe-walking completely, 4/11 decreased toe-walking, and 4/11 continued toe-walking. After 6-12 months, the toe-walking severity classification improved in 9 of the 14 children for whom data could be assessed. Conclusions: A single injection of BTX in combination with an exercise program can improve the walking pattern in children with ITW seen at gait analysis, but the obvious goal of ceasing toe-walking is only occasionally reached.
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