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

NCT06617884 | Recruiting

• 1 other identifier: 2022-1994
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ataxia; Parkinson Disease

Keywords

Training; home-based; video-based; motion capturing; movement disorders; Ataxia; PD; Parkinsons Disease

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (25)

• stride time

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

• step width

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

• cadence

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

• Lat Step Dev

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

• Toe Out Angle

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

Study Arms (3)

4 x 20 minutes training per week

EXPERIMENTAL

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.

Other: Gait and balance training

2 x 40 minutes training per week

EXPERIMENTAL

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.

Other: Gait and balance training

control group

NO INTERVENTION

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.

Interventions

Gait and balance training 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; 4 x 20 minutes training per week

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forschungszentrum Juelich: lead
• Heinrich-Heine University, Duesseldorf: collaborator

Study Sites (1)

Universitätsklinikum Düsseldorf, Institut für Klinische Neurowissenschaften und Medizinische Psychologie

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 17695343 BACKGROUND

• 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.

  PMID: 22140200 BACKGROUND

MeSH Terms

Conditions

Ataxia; Parkinson Disease; Movement Disorders

Interventions

Gait

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Martina Minnerop, PD Dr. med.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Minnerop, PD Dr. med.

CONTACT

+49246161-2125; m.minnerop@fz-juelich.de

Clara Rentz, M. Sc.

CONTACT

+492461612125; c.rentz@fz-juelich.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator who carries out the neurological examination after the training phase is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 1, 2024
• Study Start: January 4, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)