Clinical trial NCT06617884: Home-based Gait and Balance Training in Patients with Movement Disorders
Official title: Comparison of Two Home-based Gait and Balance Trainings with Different Training Frequencies in Patients with Parkinson's Disease and Ataxia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ataxia
Parkinson Disease
Keywords: Training
home-based
video-based
motion capturing
movement disorders
Ataxia
PD
Parkinsons Disease
Lead sponsor: Forschungszentrum Juelich
Sponsor class: OTHER
Collaborators: name: Heinrich-Heine University, Duesseldorf
First posted: 2024-10-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients initially take part in a one-week familiarization phase without training and are then randomly assigned to one of the two training protocols or to the control group without additional training. The two different training protocols are: 20 minutes of training per day, four days per week; or 40 minutes of training per day, only two days per week. The patients who were assigned to the control group without additional training can also complete the training after the end of the study.
Primary purpose: TREATMENT

Brief summary: The research project is an experimental study with three study visits at the study site at the University Hospital Düsseldorf (UKD) / Heinrich Heine University Düsseldorf (HHU) and a three-week training phase in a parallel design. Patients with movement disorders (ataxia or Parkinson\&amp;#39;s disease) can take part. The training phase includes individually adapted, targeted, video-based coordination and balance training, which should lead to an improvement in gait and balance. Two different training protocols are carried out in parallel for three weeks each: One with 20 minutes of training per day, four days per week; and one with a training duration of 40 minutes per day, only two days per week. All patients initially take part in a one-week familiarization phase without training and are then randomly assigned to one of the two training protocols or the control group without additional training. In both training phases, the total amount of weekly training time is the same, but the frequency and duration of training sessions per week differs. The patients who were assigned to the control group without additional training can complete the training after their third study visit.

Detailed description: 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

Primary outcomes:
measure: gait velocity
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
Secondary outcomes:
measure: stride time
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: step width
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: cadence
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: Lat Step Dev
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: Toe Out Angle
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: Double Support Time
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: Toe Off Angle
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: sway area
timeFrame: rom enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: sway velocity
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: sway path
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: arm-pelvis distance
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: foot elevation
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: trunk ROM
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: UPDRS score
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: Hoehn and Yahr score
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: SCAFI score
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: FARS-ADL score
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: EQ-5D-SL score
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: TUG time
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: FAHW score
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: ABC-D score
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: MSWS-12
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: PDQ-39
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: PGIC
timeFrame: At the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
measure: SARA score
timeFrame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf, Institut für Klinische Neurowissenschaften und Medizinische Psychologie
state: NRW
Study officials:
affiliation: Institut für Neurowissenschaften und Medizin (INM-1), Forschungszentrum Jülich GmbH
name: Martina Minnerop, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
citation: Miyai I, Ito M, Hattori N, Mihara M, Hatakenaka M, Yagura H, Sobue G, Nishizawa M; Cerebellar Ataxia Rehabilitation Trialists Collaboration. Cerebellar ataxia rehabilitation trial in degenerative cerebellar diseases. Neurorehabil Neural Repair. 2012 Jun;26(5):515-22. doi: 10.1177/1545968311425918. Epub 2011 Dec 2.