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

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 Overview

• Status: Completed
• Conditions: Myotonic Dystrophy Type 1 (DM1)
• Intervention / Treatment: Device: Tyromotion Amadeo and Armeo Senso

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Viken
    • Vikersund, Viken, Norway, 3370
      • Vikersund Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Technorehab; Rehabilitation using Tyromotion Amadeo and Armeo Senso	Device: Tyromotion Amadeo and Armeo Senso; Robot assisted rehabilitation for arm- and hand function with Tyromotion Amadeo and Armeo Senso

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fine motor skill dexterity test, 9 hole peg test (9HPT)	Motor skill test	1-3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion (ROM)	Measure of ROM in upper limb joints	5-10 minutes
Nut and Bolt test	Motor skill test	5 minutes
Hand strength	Measured by Jamar digital dynamometer	5 minutes
Pinch Gauge	Finger strength measures by Jamar digital pinch gauge	5 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abilhand	Patient reported outcome measure, measure of manual ability for adults with upper limb impairment	5 minutes
Myotonia behavior scale	Patient reported outcome measure	1-5 minutes

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital; Vikersund Rehabilitation Center
• Investigators: Principal Investigator: Hilde Stendal Robinson, PhD, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Muscular Disorders, Atrophic; Heredodegenerative Disorders, Nervous System; Muscular Dystrophies; Myotonic Disorders; Myotonic Dystrophy
• Other Study ID Numbers: 256361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No