NCT06708468 Personalized Training for People With Rare Neuromuscular Disorders
| NCT ID | NCT06708468 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Neuromuscular Diseases (NMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-12-13 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-12-13 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to investigate the effects of personalized exercise treatment on dynamic balance and physical function in comparison with regular follow-up in adults with rare-neuromuscular disorders: Charcot-Marie-Tooth (CMT), Facioscapulohumeral Muscular Dystrophy (FSHD), and Myotonic Dystrophy Type 1 (DM1). The key objectives are: 1. To investigate if the intervention group experiences improvements in dynamic balance that are superior to the control group 2. To investigate if the intervention group experiences long-term improvements in dynamic balance that are superior to the control group during the follow-up 3. To investigate if improvements in dynamic balance are associated with improvements in physical activity, body composition, estimated motor units, metabolomics, muscle echnogenecity and volume, and other indicators of health and quality of life. This is a national study and will involve 120 individuals with rare-neuromuscular disorders from Norway's four health regions.
Eligibility Criteria
Inclusion Criteria: * A confirmed diagnosis of either FSHD, DM1 or CMT * 18-70 years of age at the time of signing the informed consent. * Any gender * Ability to stand, rise from a chair and walk at least 10 meters with or without any need of assistive devices * Indication for rehabilitation as confirmed by the treating neurologist or physiotherapist * Ability to understand and follow instructions in Norwegian * Capable of giving signed informed consent Exclusion Criteria: * Pregnancy or planning to become pregnant * Any other neurological or non-neurological disorders affecting physical capacity, such as disabling arthritis, severe heart-failure/cardiomyopathy, on-going cancer treatment * Alcohol or drug abuse as per their medical chart * History of non-compliance to medical advice/follow-up
Contact & Investigator
Kristin Ørstavik, MD, PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT06708468 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Neuromuscular Diseases (NMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06708468 currently recruiting?
Yes, NCT06708468 is actively recruiting participants. Contact the research team at krorstav@ous-hf.no for enrollment information.
Where is the NCT06708468 trial being conducted?
This trial is being conducted at Bergen, Norway, Molde, Norway, Namsos, Norway, Oslo, Norway and 1 additional location.
Who is sponsoring the NCT06708468 clinical trial?
NCT06708468 is sponsored by Oslo University Hospital. The principal investigator is Kristin Ørstavik, MD, PhD at Oslo University Hospital. The trial plans to enroll 120 participants.