Inclusion Body MyositisRisk of fallNCT07072676
The Use of Assistive Gait Devices Can Reduce the Risk of Falls in Patients With Neuromuscular Diseases Following a Training Period.
A study testing Assistive gait devices combined with physiotherapy in people with Inclusion Body Myositis and Myotonic Dystrophy 1, run by LMU Klinikum at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 65 years
- Conditions the study is for
- Inclusion Body Myositis, Myotonic Dystrophy 1, Myotonic Dystrophy 2
- What is being tested?
- Assistive gait devices combined with physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2025to 1 Aug 2028
- 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 65 to 65 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The Patients with sufficient cognitive and communicative abilities,
- The Patients with confirmed by the genetic report and/or the final clinical diagnosis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Inclusion Body Myositis, Myotonic Dystrophy 1, Myotonic Dystrophy 2, Facio-Scapulo-Humeral Dystrophy, Limb Girdle Muscular Dystrophies, Pompe Disease (Infantile-Onset)
- Being tested
- Assistive gait devices combined with physiotherapy
- Keywords
- assistive gait device, neuromuscular diseases
- Medical subject headings
- Myositis, Inclusion Body, Myotonic Dystrophy, Muscular Dystrophy, Facioscapulohumeral, Muscular Dystrophies, Limb-Girdle, Glycogen Storage Disease Type II, Lambert-Eaton Myasthenic Syndrome, Muscular Atrophy, Spinal, Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistive gait devices combined with physiotherapyDevice
During the intervenation week, the patient undergoes 12 hours/week of gait training, fall prevention, balance group and physiotherapy as part of their inpatient rehabilitation programme. The individual sessions last 30 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention period | No intervention | One week without therapy with asssisitive gait devices. During this week, patients undergoing inpatient rehabilitation receive standard therapy for neuromuscular disorders. |
| Intervention period | Experimental | One week therapy with assisitve gait devices. Receives: Device: Assistive gait devices combined with physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
The aim of this test is to walk as far as possible for 6 minutes.
Measured: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
Timed Up and Go (TUG)
The TUG test measures the time it takes to stand up from a chair, walk three metres, turn around and sit back down on the same chair.
Measured: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
10 meter walk test
Walking at maximum speed is measured in a long, flat-surface corridor of 10 meters, with a standing start and a "flying" finish 2.5 meters beyond the 10-meter mark.
Measured: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
Dynamic Gait Index
Dynamic Gait Index tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls.
Measured: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
Secondary outcomes (1)
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
The QUEST 2.0 evaluates a patient's satisfaction with various assistive technologies.
Measured: At the end of post-intervention period, Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inclusion Body MyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A study protocol was developed with two cohorts that underwent a one-week pre-post intervention with gait assistive devices. The first group consisted of patients (n= 15) requiring orthopaedic support: Knee and/or ankle foot orthoses and orthopaedic shoes; the second group (n= 15) consists of patients requiring mobility aids: Forearm crutches, rollators and walking aids.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Mijic, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072676
- Sponsor's protocol ID
- 25-0252
- Other IDs
- 25-0252
- Acronym
- Risk of fall
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with the guidelines of the Ethics Committee.
Publications
Dias N, Kempen GI, Todd CJ, Beyer N, Freiberger E, Piot-Ziegler C, Yardley L, Hauer K. [The German version of the Falls Efficacy Scale-International Version (FES-I)]. Z Gerontol Geriatr. 2006 Aug;39(4):297-300. doi: 10.1007/s00391-006-0400-8. German.
PubMed 16900450Waterval NFJ, Brehm MA, Altmann VC, Koopman FS, Den Boer JJ, Harlaar J, Nollet F. Stiffness-Optimized Ankle-Foot Orthoses Improve Walking Energy Cost Compared to Conventional Orthoses in Neuromuscular Disorders: A Prospective Uncontrolled Intervention Study. IEEE Trans Neural Syst Rehabil Eng. 2020 Oct;28(10):2296-2304. doi: 10.1109/TNSRE.2020.3018786. Epub 2020 Aug 24.
PubMed 32833637Ounpuu S, Garibay E, Acsadi G, Brimacombe M, Pierz K. The impact of orthoses on gait in children with Charcot-Marie-Tooth disease. Gait Posture. 2021 Mar;85:198-204. doi: 10.1016/j.gaitpost.2021.02.005. Epub 2021 Feb 12.
PubMed 33610823Mijic M, Wirner-Piotrowski C, Jung A, Gutschmidt K, Arndt M, Garcia-Angarita N, Wenninger S, Young P, Schoser B. The assistive gait devices and their implementation in activities of daily living for patients with neuromuscular disease: A systematic review and meta-analysis. J Neuromuscul Dis. 2026 Jan;13(1):53-76. doi: 10.1177/22143602241289216. Epub 2024 Dec 8.
PubMed 39973408Dharmadasa T, Matamala JM, Huynh W, Zoing MC, Kiernan MC. Chapter 22 - Motor neurone disease. In: Day BL, Lord SRBT-H of CN, editors. Balanc. Gait, Falls, vol. 159, Elsevier; 2018, p. 345-57. https://doi.org/https://doi.org/10.1016/B978-0-444-63916-5.00022-7
Atalaia A, Thompson R, Corvo A, Carmody L, Piscia D, Matalonga L, Macaya A, Lochmuller A, Fontaine B, Zurek B, Hernandez-Ferrer C, Reinhard C, Gomez-Andres D, Desaphy JF, Schon K, Lohmann K, Jennings MJ, Synofzik M, Riess O, Yaou RB, Evangelista T, Ratnaike T, Bros-Facer V, Gumus G, Horvath R, Chinnery P, Laurie S, Graessner H, Robinson P, Lochmuller H, Beltran S, Bonne G. A guide to writing systematic reviews of rare disease treatments to generate FAIR-compliant datasets: building a Treatabolome. Orphanet J Rare Dis. 2020 Aug 12;15(1):206. doi: 10.1186/s13023-020-01493-7.
PubMed 32787960
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Assistive Gait Devices Can Reduce the Risk of Falls in Patients With Neuromuscular Diseases Following a Training Period.
- ClinicalTrials.gov ID
- NCT07072676
- Acronym / sponsor ID
- Risk of fall / 25-0252
- Conditions
- Inclusion Body Myositis, Myotonic Dystrophy 1, Myotonic Dystrophy 2, Facio-Scapulo-Humeral Dystrophy, Limb Girdle Muscular Dystrophies, Pompe Disease (Infantile-Onset)
- Keywords
- assistive gait device, neuromuscular diseases
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A study protocol was developed with two cohorts that underwent a one-week pre-post intervention with gait assistive devices. The first group consisted of patients (n= 15) requiring orthopaedic support: Knee and/or ankle foot orthoses and orthopaedic shoes; the second group (n= 15) consists of patients requiring mobility aids: Forearm crutches, rollators and walking aids.
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention period | No intervention | –One week without therapy with asssisitive gait devices. During this week, patients undergoing inpatient rehabilitation receive standard therapy for neuromuscular disorders. |
| Intervention period | Experimental | Device: Assistive gait devices combined with physiotherapyOne week therapy with assisitve gait devices. |
Who may qualify
- Ages
- 65 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- The Patients with sufficient cognitive and communicative abilities,
- The Patients with confirmed by the genetic report and/or the final clinical diagnosis.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assistive gait devices combined with physiotherapyDuring the intervenation week, the patient undergoes 12 hours/week of gait training, fall prevention, balance group and physiotherapy as part of their inpatient rehabilitation programme. The individual sessions last 30 minutes each. | Device | Intervention period |
Primary outcome
6 Minute Walk Test
Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
The aim of this test is to walk as far as possible for 6 minutes.
Timed Up and Go (TUG)
Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
The TUG test measures the time it takes to stand up from a chair, walk three metres, turn around and sit back down on the same chair.
10 meter walk test
Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
Walking at maximum speed is measured in a long, flat-surface corridor of 10 meters, with a standing start and a "flying" finish 2.5 meters beyond the 10-meter mark.
Dynamic Gait Index
Time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.
Dynamic Gait Index tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls.
1 secondary outcome
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Time frame: At the end of post-intervention period, Day 14.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Background: PubMed 16900450Dias N, Kempen GI, Todd CJ, Beyer N, Freiberger E, Piot-Ziegler C, Yardley L, Hauer K. [The German version of the Falls Efficacy Scale-International Version (FES-I)]. Z Gerontol Geriatr. 2006 Aug;39(4):297-300. doi: 10.1007/s00391-006-0400-8. German.
- Background: PubMed 32833637Waterval NFJ, Brehm MA, Altmann VC, Koopman FS, Den Boer JJ, Harlaar J, Nollet F. Stiffness-Optimized Ankle-Foot Orthoses Improve Walking Energy Cost Compared to Conventional Orthoses in Neuromuscular Disorders: A Prospective Uncontrolled Intervention Study. IEEE Trans Neural Syst Rehabil Eng. 2020 Oct;28(10):2296-2304. doi: 10.1109/TNSRE.2020.3018786. Epub 2020 Aug 24.
- Background: PubMed 33610823Ounpuu S, Garibay E, Acsadi G, Brimacombe M, Pierz K. The impact of orthoses on gait in children with Charcot-Marie-Tooth disease. Gait Posture. 2021 Mar;85:198-204. doi: 10.1016/j.gaitpost.2021.02.005. Epub 2021 Feb 12.
- Background: PubMed 39973408Mijic M, Wirner-Piotrowski C, Jung A, Gutschmidt K, Arndt M, Garcia-Angarita N, Wenninger S, Young P, Schoser B. The assistive gait devices and their implementation in activities of daily living for patients with neuromuscular disease: A systematic review and meta-analysis. J Neuromuscul Dis. 2026 Jan;13(1):53-76. doi: 10.1177/22143602241289216. Epub 2024 Dec 8.
- BackgroundDharmadasa T, Matamala JM, Huynh W, Zoing MC, Kiernan MC. Chapter 22 - Motor neurone disease. In: Day BL, Lord SRBT-H of CN, editors. Balanc. Gait, Falls, vol. 159, Elsevier; 2018, p. 345-57. https://doi.org/https://doi.org/10.1016/B978-0-444-63916-5.00022-7
- Background: PubMed 32787960Atalaia A, Thompson R, Corvo A, Carmody L, Piscia D, Matalonga L, Macaya A, Lochmuller A, Fontaine B, Zurek B, Hernandez-Ferrer C, Reinhard C, Gomez-Andres D, Desaphy JF, Schon K, Lohmann K, Jennings MJ, Synofzik M, Riess O, Yaou RB, Evangelista T, Ratnaike T, Bros-Facer V, Gumus G, Horvath R, Chinnery P, Laurie S, Graessner H, Robinson P, Lochmuller H, Beltran S, Bonne G. A guide to writing systematic reviews of rare disease treatments to generate FAIR-compliant datasets: building a Treatabolome. Orphanet J Rare Dis. 2020 Aug 12;15(1):206. doi: 10.1186/s13023-020-01493-7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. In accordance with the guidelines of the Ethics Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assistive gait devices combined with physiotherapy in people with Inclusion Body Myositis and Myotonic Dystrophy 1, run by LMU Klinikum 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 4 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: enrolling by invitation, as of the sponsor's last update on 18 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (time frame: At Day 1, end of pre-intervention period Day 7, and at the end of post-intervation period Day 14.). The study lists 4 primary outcomes in all. 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 NCT07072676, which also lists 6 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 18 Jul 2025.