Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617884
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Home-based Gait and Balance Training in Patients with Movement Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Two Home-based Gait and Balance Trainings with Different Training Frequencies in Patients with Parkinsons Disease and Ataxia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsonamp39s 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 GPower 3197 Test family t tests Means Difference between two independent means two groups with one-sided significance with α 005 1-β 08 and a calculated effect size of 08 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
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 GPower 3197 Test family t tests Means Difference between two independent means two groups with one-sided significance with α 005 1-β 08 and a calculated effect size of 08 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None