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

NCT ID: NCT06617884

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-04
• Study Completion Date: 2025-12-31

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'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.

Conditions

Ataxia; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

4 x 20 minutes training per week

During the three-week training phase, the video-based training should be carried out at home four times a week for 20 minutes each time. The access to the training videos is provided via links.

Group Type: EXPERIMENTAL

Gait and balance training

Intervention Type: OTHER

The training includes individually adapted, targeted, video-based coordination and balance training, which should lead to an improvement in gait and balance. It includes strength, coordination and flexibility exercises.

2 x 40 minutes training per week

During the three-week training phase, the video-based training should be carried out at home two times a week for 40 minutes each time. The access to the training videos is provided via links.

Group Type: EXPERIMENTAL

Gait and balance training

Intervention Type: OTHER

The training includes individually adapted, targeted, video-based coordination and balance training, which should lead to an improvement in gait and balance. It includes strength, coordination and flexibility exercises.

control group

During the three weeks between study visit two and study visit three, no additional training is conducted. Patients who were assigned to the group without training are given access to the training material after the end of the study and can carry it out afterwards.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gait and balance training

The training includes individually adapted, targeted, video-based coordination and balance training, which should lead to an improvement in gait and balance. It includes strength, coordination and flexibility exercises.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

Forschungszentrum Juelich

OTHER

Sponsor Role: lead

Responsible Party

Martina Minnerop, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martina Minnerop, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Institut für Neurowissenschaften und Medizin (INM-1), Forschungszentrum Jülich GmbH

Locations

Universitätsklinikum Düsseldorf, Institut für Klinische Neurowissenschaften und Medizinische Psychologie

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Martina Minnerop, PD Dr. med.

Role: CONTACT

m.minnerop@fz-juelich.de

+49246161-2125

Clara Rentz, M. Sc.

Role: CONTACT

c.rentz@fz-juelich.de

+492461612125

Facility Contacts

Martina Minnerop, PD Dr. med.

Role: primary

m.minnerop@fz-juelich.de

+49 2461 61 2125

Clara Rentz, M. Sc.

Role: backup

c.rentz@fz-juelich.de

+49 2461 61 2125

References

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.

Reference Type: BACKGROUND

PMID: 17695343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22140200 (View on PubMed)

Other Identifiers

2022-1994

Identifier Type: -

Identifier Source: org_study_id