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

February 6, 2023 updated by: Hilde Stendal Robinson, University of Oslo
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

Recruiting

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Technorehab
Rehabilitation using 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)
Time Frame: 1-3 minutes
Motor skill test
1-3 minutes

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2022

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

June 1, 2024

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)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myotonic Dystrophy Type 1 (DM1)

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