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Published on: June 16, 2023
Design of the STEPS trial: a phase II randomized controlled trial evaluating eHealth-supported motor-cognitive home
Breiffni Leavy1,2, Jenny Sedhed3,4, Elke Kalbe5
1Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden. breiffni.leavy@ki.se.
Background:
Electronic health (eHealth) technology offers the potential to support and motivate physical activity for symptom management in Parkinson's disease (PD). It is also recommended that motor exercise in PD be complemented with cognitive training aimed at attentional or executive functions. This paper describes the protocol for a double-blind randomized controlled trial to evaluate the effects of motor-cognitive training in the home environment, supported by eHealth.
Methods/Design:
The Support for home Training using Ehealth in Parkinsons diseaSe (STEPS) is a double-blind single center randomized controlled trial. Two parallel groups will include in total 120 participants with mild to moderate PD who will receive either (i) the intervention (a progressive 10-week individualized motor-cognitive eHealth training with cognitive behavioral elements to increase physical activity levels) or (ii) an active control group (an individualized 10-week paper-based home exercise program). The active control group will not receive motor-cognitive exercises or cognitive behavioral approaches to increase physical activity level. The primary outcome is walking capacity assessed by the six-minute walk test (6MWT). Secondary outcomes will include gait performance during single and dual task conditions, gait speed, functional mobility and lower limb strength, balance, physical activity behavior and a range of patient reported outcome measures relevant in PD.
Discussion:
The STEPS trial will answer the question whether 10 weeks of eHealth supported motor-cognitive exercise in the home environment can improve walking capacity in PD when compared to a standard paper exercise program. Findings from this study will also strengthen the evidence concerning the efficacy of PD-specific eHealth interventions with a view meeting future health care demands by addressing issues of inaccessibility to specialized neurological rehabilitation in PD.
Trial Registration:
ClinicalTrials.gov August 2022, NCT05510739.
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