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AtaxiaNCT06617884

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

A study testing Gait and balance training in people with Ataxia and Parkinson Disease, run by Forschungszentrum Juelich at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ataxia, Parkinson Disease
What is being tested?
Gait and balance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteGermany
Study dates
4 Jan 2023to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • clinical diagnosis of cerebellar ataxia or idiopathic Parkinson's syndrome
  • opportunity to walk a distance of four meters unhindered at home

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Martina Minnerop, PD Dr. med. contact

+49246161-2125

m.minnerop@fz-juelich.de

Clara Rentz, M. Sc. contact

+492461612125

c.rentz@fz-juelich.de

Germany1 site, 1 recruiting
  • Universitätsklinikum Düsseldorf, Institut für Klinische Neurowissenschaften und Medizinische Psychologie

    Düsseldorf, North Rhine-Westphalia, 40225

    Martina Minnerop, PD Dr. med., +49 2461 61 2125, m.minnerop@fz-juelich.de

    Clara Rentz, M. Sc., +49 2461 61 2125, c.rentz@fz-juelich.de

    Recruiting

Other trials in Germany

About this study

Official title: Comparison of Two Home-based Gait and Balance Trainings With Different Training Frequencies in Patients With Parkinson's Disease and Ataxia

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.

Read the 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.

Being tested
Gait and balance training
Keywords
Training, home-based, video-based, motion capturing, movement disorders, Ataxia, PD, Parkinsons Disease
Medical subject headings
Ataxia, Parkinson Disease, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gait and balance trainingOther

    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.

Study groups in NCT06617884
Study groupRoleWhat they receive
4 x 20 minutes training per weekExperimentalDuring 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.
Receives: Other: Gait and balance training
2 x 40 minutes training per weekExperimentalDuring 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.
Receives: Other: Gait and balance training
control groupNo interventionDuring 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. gait velocity

    measured in m/s, measured by a force plate (zebris), a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

Secondary outcomes (25)
  1. stride time

    time needed for one stride (two steps) measured in s, measured by a force plate (zebris), a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  2. step width

    measured in cm, measured by a force plate (zebris), a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  3. cadence

    number of steps per second, measured in s^-1, measured by a force plate (zebris), a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  4. Lat Step Dev

    Lateral Step Deviation / step width variability (SD / CV), measured in cm, measured by a force plate (zebris), a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  5. Toe Out Angle

    Foot rotation, measured in degrees, measured by a force plate (zebris) and a motion capturing system (Xsens) at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  6. Double Support Time

    Double Support Time, measured percentage of whole gait cycle, measured by a force plate (zebris) and a motion capturing system (Xsens) at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  7. Toe Off Angle

    Take off angle of foot at \"toe off\" position, measured in degrees, measured by a motion capturing system (Xsens) at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  8. sway area

    Center of mass / center of pressure 95% ellipse area, measured in mm2, measured in all stance tasks by a force plate (zebris), a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: rom enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  9. sway velocity

    Center of mass / center of pressure path length per time, measured in mm/s, measured in all stance tasks by a force plate (zebris), a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  10. sway path

    Center of mass / center of pressure path in xy-plane, measured in mm, measured in all stance tasks by a force plate (zebris), a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  11. arm-pelvis distance

    Distance from the arms to the pelvis, measured in mm, measured in all stance tasks by a motion capturing system (Xsens) at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  12. foot elevation

    maximum foot elevation during gait, measured in cm, measured in all gait tasks by a motion capturing system (Xsens) at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  13. trunk ROM

    Trunk range of motion in xy-plane, measured in mm, measured by a motion capturing system (Xsens) and individual smartphones of the participants at week 0, at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  14. UPDRS score

    Unified Parkinson Disease Rating Scale, assessed via neurological examination at week 0, after training or no training (week 4) and after training for the control group (week 7), only for the patient group of Parkinsons Disease.

    A higher score means a worse outcome. Range: 0-76

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  15. Hoehn and Yahr score

    Hoehn and Yahr scale, assessed via neurological examination at week 0, after training or no training (week 4) and after training for the control group (week 7), only for the patient group of Parkinsons Disease.

    A higher score means worse outcome. Range: 0-5

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  16. SCAFI score

    Spinocerebellar Ataxia Functional Index, assessed via neurological examination at week 0, after training or no training (week 4) and after training for the control group (week 7), only for the patient group of Ataxia.

    Separate values are reportet for the 8-meter-walk-test (8MW, in seconds, higher score means worse outcome), 9-hole pegboard test (9HPT, in seconds, higher score means worse outcome) and PATA task (PATA, number of repetitions, higher score means better outcome).

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  17. FARS-ADL score

    Activities of daily living, Rating Scale for Friedreichs Ataxia, assessed via neurological examination at week 0, after training or no training (week 4) and after training for the control group (week 7), only for the patient group of Ataxia.

    A higher score means worse outcome. Range: 0-36.

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  18. EQ-5D-SL score

    Quality of life questionnaire, assessed via questionnaire at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Health status is assessed in % from 0-100, a higher score means better outcome.

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  19. TUG time

    time to complete Timed Up and Go test, assessed via neurological examination at week 0, after training or no training (week 4) and after training for the control group (week 7).

    Measured in seconds, a higher score means a worse outcome.

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  20. FAHW score

    Fragebogen zum allgemeinen habituellen Wohlbefinden (general habitual well-being questionnaire), assessed via questionnaire at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    A higher score means better outcome.

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  21. ABC-D score

    German version of the Activity-Specific Balance Confidence scale, assessed via questionnaire at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    Measured in mean %, a higher score means a better outcome. Range: 0-100.

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  22. MSWS-12

    German Version of Multiple Sclerosis Walking Scale, assessed via questionnaire at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7).

    A higher score means a worse outcome. Range: 12-60.

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  23. PDQ-39

    Parkinsons Disease Questionnaire, assessed via questionnaire at baseline (week 1), after training or no training (week 4) and after training for the control group (week 7), only for the patient group of Parkinsons Disease.

    A higher score means a worse outcome. Range: 0-156.

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  24. PGIC

    Patient global impression of change (7-point Likert scale), assessed via questionnaire, after training (week 4) or after training for the control group (week 7).

    A higher score means a better outcome. Range: -3 to 3 for each item.

    Measured: At the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

  25. SARA score

    Scale for the Assessment and Rating of Ataxia, assessed via neurological examination at week 0, after training or no training (week 4) and after training for the control group (week 7), only for the patient group of Ataxia.

    A higher score means a worse outcome. Range: 0-40.

    Measured: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start4 Jan 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06617884
Sponsor's protocol ID
2022-1994
Status last verified
Aug 2025
First submitted
20 Sep 2024
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Anonymized, aggregated data can be provided upon request.

Publications

  • 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.

    PubMed 17695343
  • 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.

    PubMed 22140200

Questions about this trial

What is this clinical trial studying?

A study testing Gait and balance training in people with Ataxia and Parkinson Disease, run by Forschungszentrum Juelich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martina Minnerop, PD Dr. med. (+49246161-2125, m.minnerop@fz-juelich.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

gait velocity (time frame: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06617884, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.

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