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Completed

NCT Number: NCT05560438

Technology Assisted Rehabilitation for Upper Limb Function in Myotonic Dystrophy Type 1

Myotonic Dystrophy type 1 (DM1) is a genetic multisystem disease causing muscle weakness and myotonia. As a result, upper limb function might become impaired. There are little research regarding rehabilitation and exercise for upper limb function in DM1. It is known from research on lower limb function in DM1 and other muscular dystrophies, that there are possibilities to improve function also in these deteriorating diseases. In this single subject experimental design study, 6-10 adults with DM1, who are at an inpatient rehabilitation center, will get intensive, but personally adapted senso- and robot assisted rehabilitation for arm- and hand function with Tyromotion Amadeo and Armeo Senso. These devices have previously been used in rehabilitation research for other neurological conditions. The participants will be followed up, and evaluated at a weekly basis, using video consultations. Fine motor skill dexterity test (9HPT) and the Nut and Bolt test will be used, and active range of motion (ROM) and muscle strenght and movement of upper limb will be measured. Furthermore, patient reported outcome measures (PROMS) on hand impairment and myotonia will be used, all with purpose to evaluate upper limb function.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Granted rehabilitation at Vikersund Rehabilitation center Genetical confirmed myotonic dystrophy diagnosis MIRS score between 2-5

Exclusion criteria

  • MIRS score on 1 Reduced Cognitive function and unable to participate in technological rehabilitation and digital evaluation

Treatment and study plan

Tyromotion Amadeo and Armeo Senso

Device

Robot assisted rehabilitation for arm- and hand function with Tyromotion Amadeo and Armeo Senso

Primary outcomes

  1. Fine motor skill dexterity test, 9 hole peg test (9HPT)

    Time frame: 1-3 minutes

    Motor skill test

Secondary outcomes

  1. Range of motion (ROM)

    Time frame: 5-10 minutes

    Measure of ROM in upper limb joints

  2. Nut and Bolt test

    Time frame: 5 minutes

    Motor skill test

  3. Hand strength

    Time frame: 5 minutes

    Measured by Jamar digital dynamometer

  4. Pinch Gauge

    Time frame: 5 minutes

    Finger strength measures by Jamar digital pinch gauge

Other outcomes

  1. Abilhand

    Time frame: 5 minutes

    Patient reported outcome measure, measure of manual ability for adults with upper limb impairment

  2. Myotonia behavior scale

    Time frame: 1-5 minutes

    Patient reported outcome measure

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Oslo University Hospital
  • Vikersund Rehabilitation Center

Registry information

Acronym: Technorehab

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2022
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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