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RECRUITINGINTERVENTIONAL

Personalized Training for People With Rare Neuromuscular Disorders

Personalized Exercise Training for People With Rare Neuromuscular Disorders: a Multi-center, Evaluator-blinded, Two Arm, Randomized Controlled Study to Assess the Effects on Physical Function From Personalized Strength and Balance Exercise in a Rehabilitation Setting.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - A confirmed diagnosis of either FSHD, DM1 or CMT - 18-70 years of age at the time of signing the willing to sign a consent form. - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Exercise

The intervention includes 12-day personalized exercise program set in a rehabilitation center, followed by a three-month digital intervention and then a second 12-day personalized exercise program in a rehabilitation center.

OTHER

Usual Care

Usual care includes appointments at hospitals and in the community health system according to what has been recommended to that individual

Locations (5)

Haukeland University Hospital
Bergen, Norway
Helse Møre and Romsdal HF (Molde Hospital)
Molde, Norway
Namsos Hospital
Namsos, Norway
Oslo University Hospital
Oslo, Norway
University Hospital of North Norway
Tromsø, Norway