Myotonic Dystrophy Type 1 (DM1)TechnorehabNCT05560438
Technology Assisted Rehabilitation for Upper Limb Function in Myotonic Dystrophy Type 1
A study testing Tyromotion Amadeo and Armeo Senso in people with Myotonic Dystrophy Type 1 (DM1), run by University of Oslo at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myotonic Dystrophy Type 1 (DM1)
- What is being tested?
- Tyromotion Amadeo and Armeo Senso
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNorway
- Study dates
- 3 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Granted rehabilitation at Vikersund Rehabilitation center Genetical confirmed myotonic dystrophy diagnosis MIRS score between 2-5
Who cannot join
- MIRS score on 1 Reduced Cognitive function and unable to participate in technological rehabilitation and digital evaluation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myotonic Dystrophy Type 1 (DM1)
- Being tested
- Tyromotion Amadeo and Armeo Senso
- Medical subject headings
- Myotonic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyromotion Amadeo and Armeo SensoDevice
Robot assisted rehabilitation for arm- and hand function with Tyromotion Amadeo and Armeo Senso
| Study group | Role | What they receive |
|---|---|---|
| Technorehab | Experimental | Rehabilitation using Tyromotion Amadeo and Armeo Senso Receives: Device: Tyromotion Amadeo and Armeo Senso |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fine motor skill dexterity test, 9 hole peg test (9HPT)
Motor skill test
Measured: 1-3 minutes
Secondary outcomes (4)
Range of motion (ROM)
Measure of ROM in upper limb joints
Measured: 5-10 minutes
Nut and Bolt test
Motor skill test
Measured: 5 minutes
Hand strength
Measured by Jamar digital dynamometer
Measured: 5 minutes
Pinch Gauge
Finger strength measures by Jamar digital pinch gauge
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start3 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myotonic Dystrophy Type 1 (DM1)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single subject experimental design (SSED) study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Vikersund Rehabilitation Center
- Responsible party
- Principal investigator, Hilde Stendal Robinson, University of Oslo
- Investigators
- Hilde Stendal Robinson, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560438
- Sponsor's protocol ID
- 256361
- Acronym
- Technorehab
- Status last verified
- May 2024
- First submitted
- 26 Sep 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single subject experimental design study, and the data will not be available for other researchers. This is to protect the participants identity.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Rehabilitation for Upper Limb Function in Myotonic Dystrophy Type 1
- ClinicalTrials.gov ID
- NCT05560438
- Acronym / sponsor ID
- Technorehab / 256361
- Conditions
- Myotonic Dystrophy Type 1 (DM1)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Vikersund Rehabilitation Center
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Sep 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single subject experimental design (SSED) study
| Arm | Type | Receives |
|---|---|---|
| Technorehab | Experimental | Device: Tyromotion Amadeo and Armeo SensoRehabilitation using Tyromotion Amadeo and Armeo Senso |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Granted rehabilitation at Vikersund Rehabilitation center Genetical confirmed myotonic dystrophy diagnosis MIRS score between 2-5
Key exclusion criteria (1 listed)
- MIRS score on 1 Reduced Cognitive function and unable to participate in technological rehabilitation and digital evaluation
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 |
|---|---|---|
| Tyromotion Amadeo and Armeo SensoRobot assisted rehabilitation for arm- and hand function with Tyromotion Amadeo and Armeo Senso | Device | Technorehab |
Primary outcome
Fine motor skill dexterity test, 9 hole peg test (9HPT)
Time frame: 1-3 minutes
Motor skill test
4 secondary outcomes
Range of motion (ROM)
Time frame: 5-10 minutes
Nut and Bolt test
Time frame: 5 minutes
Hand strength
Time frame: 5 minutes
Pinch Gauge
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No. This is a single subject experimental design study, and the data will not be available for other researchers. This is to protect the participants identity.
Related trials for Myotonic Dystrophy Type 1 (DM1)
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A Study of Long-term Safety and Efficacy of VX-670 in Participants With Myotonic Dystrophy Type I
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Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1
Myotonic Dystrophy Type 1 (DM1), DM1
RecruitingObservational study
The United Kingdom National Registry for Myotonic Dystrophy
Myotonic Dystrophy
Enrolling by invitationPhase 1/2
Study of SRP-1003 in Participants With Type 1 Myotonic Dystrophy
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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. This study is not recruiting at the moment.
Hilde Stendal Robinson, PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tyromotion Amadeo and Armeo Senso in people with Myotonic Dystrophy Type 1 (DM1), run by University of Oslo at 1 site in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 May 2024. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fine motor skill dexterity test, 9 hole peg test (9HPT) (time frame: 1-3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024.