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Home-based Gait and Balance Training in Patients With Movement Disorders

NCT06617884 · Forschungszentrum Juelich
In plain English

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Official title
Comparison of Two Home-based Gait and Balance Trainings With Different Training Frequencies in Patients With Parkinson's Disease and Ataxia
About this study
It will be investigated separately for the two patient groups (ataxia, Parkinsons disease), whether the video-based training can lead to an improvement in gait and balance and whether the training protocols differ with regard to the desired improvement. The gait and balance variables recorded using the two standard methods (force plate, motion capturing system) will serve as the basis for assessing the training effect. Furthermore, the investigators want to analyze how the individual variables differ between the healthy subjects (from our previous study) and patients with movement disorders. Patients can also voluntarily record movement data using their own smartphone. This has the advantage that data can also be collected at home, which is more likely to reflect the everyday life of the participants. In particular, the aim is to check whether the data collected with the smartphone can also be read and analyzed in patients, despite the increased movement variability, and whether typical movement patterns and training-related changes can be recorded. Only adults will take part in the study. The aim is to assess 21 patients with cerebellar ataxia or idiopathic Parkinsons disease per group. This number is based on a power calculation with the software G\*Power 3.1.9.7 (Test family t tests, Means: Difference between two independent means (two groups)), with one-sided significance with α = 0.05, 1-β = 0.8 and a calculated effect size of 0.8. Participants in the study will be fully informed in advance about the study procedure. Participation in the study is voluntary. Participants can withdraw from the study at any time without giving reasons and without any disadvantages. A clinical diagnosis of cerebellar ataxia or idiopathic Parkinsons disease is a prerequisite for participation in the study. Participants must also be able to walk independently for 2 minutes. Exclusion criteria are other diseases with an impact on motor skills or serious primary psychiatric illnesses, current drug or alcohol dependency, consumptive illnesses or a poor general condition. There must be no increased risk of falling. Parkinsons patients should carry out the measurements on site and at home during the on-phase of the medication, approx. 2 hours after taking the medication. Patients are recruited via the special outpatient clinic for movement disorders at the Institute for Movement Disorders and Neuromodulation at the UKD / HHU Düsseldorf. The study is discontinued for the individual study participant if an increased risk of falls becomes apparent. The study as a whole will be discontinued if it becomes apparent that the risks of the study outweigh the benefits or if unforeseen complications arise during the training phase.
Eligibility criteria
Inclusion Criteria: * clinical diagnosis of cerebellar ataxia or idiopathic Parkinson's syndrome * opportunity to walk a distance of four meters unhindered at home Exclusion Criteria: * other diseases with an impact on motor skills * severe primary psychiatric illnesses * current drug or alcohol addiction * consumptive diseases * poor general condition * increased risk of falling (anamnestic fall frequency of ≥ 1x per week or as assessed by the attending physician) * incapacitated patients in official or court custody or patients unable to give consent * for PD patients taking medication: not being able to carry out the measurement in the on-phase of the medication
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-01-04
Estimated completion: 2025-12
Last updated: 2025-08-13
Interventions
Other: Gait and balance training
Primary outcomes
  • gait velocity (From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups))
Sponsor
Forschungszentrum Juelich · other
With: Heinrich-Heine University, Duesseldorf
Contacts & investigators
ContactMartina Minnerop, PD Dr. med. · contact · m.minnerop@fz-juelich.de · +49246161-2125
ContactClara Rentz, M. Sc. · contact · c.rentz@fz-juelich.de · +492461612125
InvestigatorMartina Minnerop, PD Dr. med. · principal_investigator, Institut für Neurowissenschaften und Medizin (INM-1), Forschungszentrum Jülich GmbH
All locations (1)
Universitätsklinikum Düsseldorf, Institut für Klinische Neurowissenschaften und Medizinische PsychologieRecruiting
Düsseldorf, North Rhine-Westphalia, Germany
Home-based Gait and Balance Training in Patients With Movement Disorders · TrialPath