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Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson's disease: the DUALITY trial.

ABSTRACT: Multiple tasking is an integral part of daily mobility. Patients with Parkinson's disease have dual tasking difficulties due to their combined motor and cognitive deficits. Two contrasting physiotherapy interventions have been proposed to alleviate dual tasking difficulties: either to discourage simultaneous execution of dual tasks (consecutive training); or to practice their concurrent use (integrated training). It is currently unclear which of these training methods should be adopted to achieve safe and consolidated dual task performance in daily life. Therefore, the proposed randomized controlled trial will compare the effects of integrated versus consecutive training of dual tasking (tested by combining walking with cognitive exercises).Hundred and twenty patients with Parkinson's disease will be recruited to participate in this multi-centered, single blind, randomized controlled trial. Patients in Hoehn & Yahr stage II-III, with or without freezing of gait, and who report dual task difficulties will be included. All patients will undergo a six-week control period without intervention after which they will be randomized to integrated or consecutive task practice. Training will consist of standardized walking and cognitive exercises delivered at home four times a week during six weeks. Treatment is guided by a physiotherapist twice a week and consists of two sessions of self-practice using an MP3 player. Blinded testers will assess patients before and after the control period, after the intervention period and after a 12-week follow-up period. The primary outcome measure is dual task gait velocity, i.e. walking combined with a novel untrained cognitive task to evaluate the consolidation of learning. Secondary outcomes include several single and dual task gait and cognitive measures, functional outcomes and a quality of life scale. Falling will be recorded as a possible adverse event using a weekly phone call for the entire study period.This randomized study will evaluate the effectiveness and safety of integrated versus consecutive task training in patients with Parkinson's disease. The study will also highlight whether dual task gait training leads to robust motor learning effects, and whether these can be retained and carried-over to untrained dual tasks and functional mobility.Clinicaltrials.gov NCT01375413.

SUBMITTER: Strouwen C

PROVIDER: S-EPMC3974198 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson's disease: the DUALITY trial.

Strouwen Carolien C Molenaar Esther A L M EA Keus Samyra H J SH Münks Liesbeth L Munneke Marten M Vandenberghe Wim W Bloem Bastiaan R BR Nieuwboer Alice A

BMC neurology 20140327

<h4>Background</h4>Multiple tasking is an integral part of daily mobility. Patients with Parkinson's disease have dual tasking difficulties due to their combined motor and cognitive deficits. Two contrasting physiotherapy interventions have been proposed to alleviate dual tasking difficulties: either to discourage simultaneous execution of dual tasks (consecutive training); or to practice their concurrent use (integrated training). It is currently unclear which of these training methods should b ...[more]

PMID: 24674594

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Project description:Patients with Parkinson's disease (PD) have difficulties while performing dual-task activities, a condition present in everyday life. It is possible that strategies such as transcranial Direct Current Stimulation (tDCS) can be associated with motor training enriched with dual-task training to improve the performance of two concurrent tasks. Currently, it is unclear whether specific tasks and clinical conditions of PD patients have different results after the intervention. Therefore, the proposed randomized controlled trial will examine task-dependency in enhancing the effects of tDCS-linked rehabilitation training on PD and the relationships between baseline outcomes in responders and non-responders to therapy. Fifty-six patients with Parkinson's disease will be recruited to participate in this controlled, double-blind randomized multicentric clinical trial. Patients in modified Hoehn & Yahr stage 1.5-3, age between 40 and 70 years will be included. Subjects will be randomly assigned to an experimental group (EG) and a control group (CG). The EG will perform treadmill gait training associated with dual task exercises+tDCS, while the CG will only engage in treadmill gait training+tDCS. Blinded testers will assess patients before and after 12 intervention sessions and after a 4-week follow-up period. All patients will undergo a screening and an initial visit before being assessed for primary and secondary outcomes. The primary outcome measure is functional mobility measured by Timed Up and Go Test. Secondary outcomes include cognitive function, participation, motor function and body function and structure. This study will evaluate the effectiveness of an intervention protocol with tDCS, dual-task training and gait training in patients with PD. The study will also highlight the clinical factors and variability between individuals that could interfere in the training of a specific task and influence the therapeutic effect. Clinical Trial registration: www.ClinicalTrials.gov, identifier NCT04581590.

Project description:BackgroundGait disorders and cognitive impairments are prime causes of disability and institutionalization after stroke. We hypothesized that relative to single-task gait rehabilitation (ST GR), cognitive-motor dual-task (DT) GR initiated at the subacute stage would be associated with greater improvements in ST and DT gait, balance, and cognitive performance, personal autonomy, disability, and quality of life in the short, medium and long terms after stroke.MethodsThis multicenter (n=12), two-arm, parallel-group, randomized (1:1), controlled clinical study is a superiority trial. With p<0.05, a power of 80%, and an expected loss to follow-up rate of 10%, the inclusion of 300 patients will be required to evidence a 0.1-m.s-1 gain in gait speed. Trial will include adult patients (18-90 years) in the subacute phase (0 to 6 months after a hemispheric stroke) and who are able to walk for 10 m (with or without a technical aid). Registered physiotherapists will deliver a standardized GR program (30 min three times a week, for 4 weeks). The GR program will comprise various DTs (phasic, executive function, praxis, memory, and spatial cognition tasks during gait) in the DT (experimental) group and gait exercises only in the ST (control) group. The primary outcome measure is gait speed 6 months after inclusion. The secondary outcomes are post-stroke impairments (National Institutes of Health Stroke Scale and the motor part of the Fugl-Meyer Assessment of the lower extremity), gait speed (10-m walking test), mobility and dynamic balance (timed up-and-go test), ST and DT cognitive function (the French adaptation of the harmonization standards neuropsychological battery, and eight cognitive-motor DTs), personal autonomy (functional independence measure), restrictions in participation (structured interview and the modified Rankin score), and health-related quality of life (on a visual analog scale). These variables will be assessed immediately after the end of the protocol (probing the short-term effect), 1 month thereafter (the medium-term effect), and 5 months thereafter (the long-term effect).DiscussionThe main study limitation is the open design. The trial will focus on a new GR program applicable at various stages after stroke and during neurological disease.Trial registrationNCT03009773 . Registered on January 4, 2017.

Project description:BackgroundFunctional independence and safe mobility, especially in older people, mostly rely on the ability to perform dual tasks, particularly during activities with variable- and fixed-priority attention. The aim of this study is to compare the dual-task training with progression from variable- to fixed-priority instructions versus dual-task training with variable-priority on gait speed in community-dwelling older adults.MethodsThis is an assessor- and participant-blinded, two-arm, randomized controlled trial with 60 community-dwelling male and female older adults between the ages of 60 and 80 years old. Participants will be randomly allocated into either the intervention group or the control group using a computer-generated permuted block randomization schedule. The intervention group will undertake a progressive dual-task training in which the participants will be progressively submitted to dual-task walking and postural balance exercises with variable- to fixed-priority instructions. The control group will be submitted to dual-task training with variable-priority attention exercises. Both groups will receive 48 sessions lasting for 60 min each over 24 weeks. The primary outcome will be the gait speed under single- and dual-task conditions. Secondary outcomes will include spatiotemporal gait parameters, functional balance, executive function, falls, quality of life, and depression symptoms. All the analyses will be based on the intention-to-treat principle.DiscussionThis is the first assessor- and participant-blinded, two-arm, randomized controlled trial with 6 months of intervention and an additional 6-month post-training follow up aiming to evaluate the effectiveness of training with progression from variable- to fixed-priority instructions on gait biomechanics, postural balance, falls episodes, executive functioning, and quality of life in community-dwelling older adults. If our hypotheses are confirmed, this training protocol can be implemented widely to improve gait speed and other functional activities and quality of life in community-dwelling older adults. This study protocol can be used to improve these functional aspects of community-dwelling older adults. This study may also contribute to future guidelines for the improvement of these clinical and biomechanical aspects in older people.Trial registrationClinicalTrials.gov Identifier - NCT03886805, Registered 22 March 2019.

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Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson's disease: the DUALITY trial.

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Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson's disease: the DUALITY trial.

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