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

Myotonic Dystrophy Type 1 (DM1) Clinical Trial

— Technorehab  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560438
• Other study ID #: 256361
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: University of Oslo
• Contact: Hilde Stendal Robinson, PhD
• Phone: +47 90607081
• Email: h.s.robinson[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Myotonic Dystrophy
• Myotonic Dystrophy Type 1 (DM1)

Intervention

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

Locations

Country	Name	City	State
Norway	Vikersund Rehabilitation Center	Vikersund	Viken

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Oslo University Hospital, Vikersund Rehabilitation Center

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Abilhand	Patient reported outcome measure, measure of manual ability for adults with upper limb impairment	5 minutes
Other	Myotonia behavior scale	Patient reported outcome measure	1-5 minutes
Primary	Fine motor skill dexterity test, 9 hole peg test (9HPT)	Motor skill test	1-3 minutes
Secondary	Range of motion (ROM)	Measure of ROM in upper limb joints	5-10 minutes
Secondary	Nut and Bolt test	Motor skill test	5 minutes
Secondary	Hand strength	Measured by Jamar digital dynamometer	5 minutes
Secondary	Pinch Gauge	Finger strength measures by Jamar digital pinch gauge	5 minutes