ClinicalTrials.gov record NCT07072676

The Use of Assistive Gait Devices Can Reduce the Risk of Falls in Patients With Neuromuscular Diseases Following a Training Period.

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

The Use of Assistive Gait Devices Can Reduce the Risk of Falls in Patients With Neuromuscular Diseases Following a Training Period.

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age65 years old to 65 years old
SexAll
LocationGermany
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study tests whether fitting and training people with various neuromuscular diseases in suitable assistive gait devices changes measures of fall risk and walking/balance. Participants undergo one week of inpatient rehabilitation without assistive devices, then one week with a fitted assistive gait device and supervised physiotherapy (about 12 hours/week of training). Functional walking and balance tests and questionnaires are recorded at Day 1, Day 7 and Day 14.

What it is studying. Whether providing and training people with selected neuromuscular diseases in suitable assistive gait devices changes their fall risk and functional walking and balance test results, and how satisfied people are with the devices.

What the researchers hope to learn. To measure fall risk and objective walking and balance performance before and after adaptation to assistive gait devices; to record user satisfaction with the devices; and to provide data to inform how assistive aids are provided to people with neuromuscular diseases.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The planned project is an intervention study to assess the risk of falling after adaptation of an assistive gait devices in patients with the following neuromuscular diseases: Inclusion body myositis, myotonic dystrophy, limb girdle and facioscapulohumeral muscular dystrophies, Pompe disease, Lambert-Eaton syndrome, myasthenia gravis, spinal muscular atrophy, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, Friedreich's ataxia and hereditary motor and sensory neuropathy. The primary aim is to assess the risk of falling after a suitable assistive gait device has been provided with an adaptation phase through training. The data should help to improve the provision of aids for patients with neuromuscular diseases. This should have a positive effect on the risk of falling and thus improve quality of life and reduce mortality and morbidity. To achieve these goals, a one-week intervention with training sessions on handling, balance and coordination as well as fall prevention will becarried out after the patient has been fitted with a suitable assistive gait device. The interventions will be embedded in the inpatient rehabilitation programme. The functional gait and balance tests 'Timed Up and Go', '10 metre walk test', '6-minute walk test' and 'Dynamic Gait Index' will be recorded additionally. The Falls Efficacy Scale International questionnaire will be utilised to evaluate the risk of falling, while the Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire will be employed to ascertain satisfaction with the assistive devices. The study is scheduled to run for a period of 14 days, during which participants will undergo three functional walking and balance tests. As part of the inpatient rehabilitation programme, participants will undergo a week-long period of rehabilitation without assistive technology, followed by a subsequent week of rehabilitation with adapted assistive technology.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Assistive gait devices combined with physiotherapy

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • The Patients with sufficient cognitive and communicative abilities,
  • The Patients with confirmed by the genetic report and/or the final clinical diagnosis.

Exclusion criteria

  • The Patients scored more than 23 points on the falls efficacy Scale-International
  • The Patients are unable to walk at least ten metres without assistance,
  • The patient had knee, hip or back surgery in the last three months.
  • Patients suffering from polyneuropathy without a diagnosis of inflammatory autoimmune neuropathy.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants take part in a 14-day inpatient rehabilitation programme: one week of standard rehab without assistive gait devices, then one week fitted with a suitable assistive gait device plus training. The intervention week includes about 12 hours/week of gait training, balance and fall-prevention physiotherapy (individual sessions ~30 minutes). Walking and balance tests (6‑minute walk, Timed Up and Go, 10‑metre walk, Dynamic Gait Index) are done at Day 1, Day 7 and Day 14; the Falls Efficacy Scale-International and the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire are also used. Participants are placed into one of two cohorts by the assistive device they need: one gets orthopaedic supports (e.g., knee or ankle-foot orthoses, orthopaedic shoes), the other gets mobility aids (e.g., forearm crutches, rollators). No invasive procedures are listed in the registry.

How the study is structured. Non-randomized interventional study with two sequential one-week periods: a pre-intervention week without assistive gait devices (standard inpatient rehab), followed by an intervention week with a fitted assistive gait device plus physiotherapy and training (approximately 12 hours/week). No masking. Functional walking and balance tests and questionnaires are done at Day 1, Day 7 and Day 14.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says participants are enrolled by invitation. Who decides who is invited, and how?
  • The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Pompe disease

This trial is also listed on this site under Friedreich ataxia.

Clinical trials32 trials listed for Pompe diseaseEvery trial the registry lists for Pompe disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Pompe disease researchLatest monthly update: September 2026. Includes: Antibody effects. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 1, 2025 (estimated)
Primary completion
May 1, 2027 (estimated)
Study completion
Aug 1, 2028 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Jul 18, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
LMU Klinikum
Principal investigator
Marko Mijic, Principal Investigator
LMU Klinikum

Participating sites (1)

  • Medical Park, Bad Feilnbach, Reithofpark

    Bad Feilnbach, 53075 · Germany

Terms used on this page · explanations by MedicalUpdates.ai

6-minute walk test
A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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