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Strength Training for Adolescents with cerebral palsy (STAR): study protocol of a randomised controlled trial to determine the feasibility, acceptability and efficacy of resistance training for adolescents with cerebral palsy.

ABSTRACT: INTRODUCTION:Gait is inefficient in children with cerebral palsy, particularly as they transition to adolescence. Gait inefficiency may be associated with declines in gross motor function and participation among adolescents with cerebral palsy. Resistance training may improve gait efficiency through a number of biomechanical and neural mechanisms. The aim of the Strength Training for Adolescents with cerebral palsy (STAR) trial is to evaluate the effect of resistance training on gait efficiency, activity and participation in adolescents with cerebral palsy. We also aim to determine the biomechanical and neural adaptations that occur following resistance training and evaluate the feasibility and acceptability of such an intervention for adolescents with cerebral palsy. METHODS AND ANALYSIS:60 adolescents (Gross Motor Function Classification System level I-III) will be randomised to a 10-week resistance training group or a usual care control group according to a computer-generated random schedule. The primary outcome is gait efficiency. Secondary outcomes are habitual physical activity, participation, muscle-tendon mechanics and gross motor function. General linear models will be used to evaluate differences in continuous data between the resistance training and usual care groups at 10 and 22 weeks, respectively. A process evaluation will be conducted alongside the intervention. Fidelity of the resistance training programme to trial protocol will be quantified by observations of exercise sessions. Semistructured interviews will be conducted with participants and physiotherapists following the resistance training programme to determine feasibility and acceptability of the programme. ETHICS AND DISSEMINATION:This trial has ethical approval from Brunel University London's Department of Clinical Sciences' Research Ethics Committee and the National Research Ethics Service (NRES) Committee London-Surrey Borders. The results of the trial will be submitted for publication in academic journals, presented at conferences and distributed to adolescents, families and healthcare professionals through the media with the assistance of the STAR advisory group. TRIAL REGISTRATION NUMBER:ISRCTN90378161; Pre-results.

SUBMITTER: Ryan JM

PROVIDER: S-EPMC5073599 | biostudies-other | 2016 Oct

REPOSITORIES: biostudies-other

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Strength Training for Adolescents with cerebral palsy (STAR): study protocol of a randomised controlled trial to determine the feasibility, acceptability and efficacy of resistance training for adolescents with cerebral palsy.

Ryan Jennifer M JM Theis Nicola N Kilbride Cherry C Baltzopoulos Vasilios V Waugh Charlie C Shortland Adam A Lavelle Grace G Noorkoiv Marika M Levin Wendy W Korff Thomas T

BMJ open 20161004 10

<h4>Introduction</h4>Gait is inefficient in children with cerebral palsy, particularly as they transition to adolescence. Gait inefficiency may be associated with declines in gross motor function and participation among adolescents with cerebral palsy. Resistance training may improve gait efficiency through a number of biomechanical and neural mechanisms. The aim of the Strength Training for Adolescents with cerebral palsy (STAR) trial is to evaluate the effect of resistance training on gait eff ...[more]

PMID: 27707836

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Project description:BackgroundPower bursts of hips and ankle plantar flexors are prerequisites to walking propulsion. However, these power bursts are reduced during gait for persons with cerebral palsy (CP) and mainly in the ankle plantar flexors. Hence, task specific training, such as ballistic strength training, is suggested to increase muscle power in walking but not investigated in adults with CP. Therefore, the aim was to investigate if adults with CP could perform and benefit from ballistic strength training to improve walking, evaluated through physical measures and self-reported measures and interviews.MethodsIn this mixed methods feasibility study, eight ambulatory adults (aged 24-56) with spastic CP conducted ballistic strength training on a glideboard targeting the ankle plantarflexors two times a week for eight weeks. The feasibility of the training was assessed through objectives described by Orsmond and Cohn. Before and after the intervention, physical measures (6-Minute Walk Test and the eight-item High-level Mobility Assessment Tool) and self-reported measures (Patient Global Impression of Change, Numeric Pain Rating Scale, Fatigue Impact and Severity Self-Assessment, and Walk-12) were collected. After the intervention, semi-structured interviews explored experiences of this training.ResultsThe participants experienced training the ankle plantar flexor as relevant but reported it took about four weeks to coordinate the exercises successfully. Although we observed no changes in the physical performance measures, most participants reported improvements; some felt steadier when standing, walking, and hopping.ConclusionThis study demonstrated that ballistic strength training was feasible and suitable in adults with CP. However, guidance and a long (4 weeks) familiarization time were reported necessary to master the exercises. Most participants reported self-experienced improvements, although no physical performance measures improved. Thus, prolonged intervention may be required for perceived physical improvements to emerge. Also, other outcome measures sensitive to power output remains to be investigated.

Project description:BACKGROUND: Until recently, strength training in children with cerebral palsy (CP) was considered to be inappropriate, because it could lead to increased spasticity or abnormal movement patterns. However, the results of recent studies suggest that progressive strength training can lead to increased strength and improved function, but low methodological quality and incomplete reporting on the training protocols hampers adequate interpretation of the results. This paper describes the design and training protocol of a randomized controlled trial to assess the effects of a school-based progressive functional strength training program for children with CP. METHODS/RESULTS: Fifty-one children with Gross Motor Function Classification Systems levels I to III, aged of 6 to 13 years, were recruited. Using stratified randomization, each child was assigned to an intervention group (strength training) or a control group (usual care). The strength training was given in groups of 4-5 children, 3 times a week, for a period of 12 weeks. Each training session focussed on four exercises out of a 5-exercise circuit. The training load was gradually increased based on the child's maximum level of strength, as determined by the 8 Repetition Maximum (8 RM). To evaluate the effectiveness of the training, all children were evaluated before, during, directly after, and 6 weeks after the intervention period. Primary outcomes in this study were gross motor function (measured with the Gross Motor Function Measure and functional muscle strength tests) and walking ability (measured with the 10-meter, the 1-minute and the timed stair test). Secondary outcomes were lower limb muscle strength (measured with a 6 RM test, isometric strength tests, and a sprint capacity test), mobility (measured with a mobility questionnaire), and sport activities (measured with the Children's Assessment of Participation and Enjoyment). Spasticity and range of motion were assessed to evaluate any adverse events. CONCLUSION: Randomized clinical trials are considered to present the highest level of evidence. Nevertheless, it is of utmost importance to report on the design, the applied evaluation methods, and all elements of the intervention, to ensure adequate interpretation of the results and to facilitate implementation of the intervention in clinical practice if the results are positive. TRIAL REGISTRATION: Trial Register NTR1403.

Project description:INTRODUCTION:Two-wheel bike riding can be a goal for children with cerebral palsy (CP) and a means of participating in physical activity. It is possible for some children with CP to ride a two-wheel bike; however, currently far fewer can ride compared with their typically developing peers. Evidence supports training targeted towards goals of the child with CP and their family; yet there is little evidence to guide best-practice bike skills training. Task-specific training may lead to attainment of two-wheel bike-specific goals. This study aims to determine if a novel task-specific approach to training two-wheel bike skills is more effective than a parent-led home programme for attaining individualised two-wheel bike-specific goals in independently ambulant children with CP aged 6-15 years. METHODS AND ANALYSIS:Sixty eligible children with CP (Gross Motor Function Classification System levels I-II) aged 6-15 years with goals relating to riding a two-wheel bike will be randomised to either a novel task-specific centre-based group programme (intervention) or a parent-led home-based programme (comparison), both involving a 1-week intervention period. The primary outcome is goal attainment in the week following the intervention period (T1). Secondary outcomes include: goal attainment and participation in physical activity at 3?months postintervention (T2) and bike skills, attendance and involvement in bike riding, self-perception and functional skills at T1 and T2. Economic appraisal will involve cost-effectiveness and cost-utility analyses. Adherence of clinicians and parents to the intervention and comparison protocols will be assessed. Linear and logistic regression will be used to assess the effect of the intervention, adjusted for site as used in the randomisation process. ETHICS AND DISSEMINATION:This study was approved by the Human Research and Ethics Committees at The Royal Children's Hospital (#36209). Results will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT03003026; Pre-results.

Project description:Rehabilitation for children with hemiplegic cerebral palsy (HCP) aimed to improve function of the impaired upper limb (UL) uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT) for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with HCP.The trial is designed according to CONSORT Statement. It is a randomised, evaluator-blinded, match-pair group trial. Children with HCP will be randomised within pairs to either experimental or control group. The experimental group will perform an Action-Observation Therapy, called UP-CAT (Upper Limb-Children Action-Observation Training) in which they will watch video sequences showing goal-directed actions, chosen according to children UL functional level, combined with motor training with their hemiplegic UL. The control group will perform the same tailored actions after watching computer games. A careful revision of psychometric properties of UL outcome measures for children with hemiplegia was performed. Assisting Hand Assessment was chosen as primary measure and, based on its calculation power, a sample size of 12 matched pairs was established. Moreover, Melbourne and ABILHAND-Kids were included as secondary measures. The time line of assessments will be T0 (in the week preceding the onset of the treatment), T1 and T2 (in the week after the end of the treatment and 8 weeks later, respectively). A further assessment will be performed at T3 (24 weeks after T1), to evaluate the retention of effects. In a subgroup of children enrolled in both groups functional Magnetic Resonance Imaging, exploring the mirror system and sensory-motor function, will be performed at T0, T1 and T2.The paper aims to describe the methodology of a RCT for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with hemiplegia. This study will be the first to test this new type of treatment in childhood. The paper presents the theoretical background, study hypotheses, outcome measures and trial methodology.NCT01016496.

Project description:Unilateral Cerebral Palsy (UCP), the most frequent form of Cerebral Palsy, usually affects more the upper limb (UL) than the lower limb. Rehabilitation programs are addressed to improve manual abilities and UL use. In recent years, Information and Communication Technology (ICT) has been introduced in rehabilitation to increase treatment opportunities for patients, and also in home-based intervention. Moreover, the discovery of the Mirror Neuron System allowed to insert a new paradigm of treatment that is the Action Observation Training (AOT). The aim of the present study was to investigate the feasibility of a new rehabilitative home-based approach, called Tele-UPCAT (Tele-monitored UPper Limb Children Action Observation Training), based on the principles of AOT, in a group of Italian children and adolescents with UCP. This investigation was to provide information about the possibility of introducing ICT in telerehabilitation field. Twenty-nine children aged 11.73 ± 3.65 years (range 6.00-18.75) with a diagnosis of UCP participated in the study. They carried out 15 days of training based on the AOT paradigm with Tele-UPCAT system while wearing Actigraphs on both wrists. The feasibility of both training and study design and procedures was assessed through nine criteria taken from existent literature and from a questionnaire designed and realized ad hoc for the purpose, based on standard items of usability and acceptability. All feasibility criteria were met: 80% of training sessions were completed in the planned time and no significant technical issues were found. From the questionnaire, total scores were all above 82.15%, while the four sections obtained the following scores: (i) customization of exercises 80.00%; (ii) acceptability at home, 77.50%; (iii) required effort 80.00%; and (iv) suitability of manual and software 95.00%. No differences were found for age and sex. Tele-UPCAT demonstrated to be feasible as a home-based AOT for children and adolescents with UCP. Trial registration NCT03094455.

Dataset Information

Strength Training for Adolescents with cerebral palsy (STAR): study protocol of a randomised controlled trial to determine the feasibility, acceptability and efficacy of resistance training for adolescents with cerebral palsy.

Publications

Strength Training for Adolescents with cerebral palsy (STAR): study protocol of a randomised controlled trial to determine the feasibility, acceptability and efficacy of resistance training for adolescents with cerebral palsy.

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