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

Primary Purpose

Myotonic Dystrophy Type 1 (DM1)

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tyromotion Amadeo and Armeo Senso
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myotonic Dystrophy Type 1 (DM1)

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vikersund Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Technorehab

Arm Description

Rehabilitation using Tyromotion Amadeo and Armeo Senso

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Range of motion (ROM)
Measure of ROM in upper limb joints
Nut and Bolt test
Motor skill test
Hand strength
Measured by Jamar digital dynamometer
Pinch Gauge
Finger strength measures by Jamar digital pinch gauge

Full Information

First Posted
September 26, 2022
Last Updated
February 6, 2023
Sponsor
University of Oslo
Collaborators
Oslo University Hospital, Vikersund Rehabilitation Center
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1. Study Identification

Unique Protocol Identification Number
NCT05560438
Brief Title
Technology Assisted Rehabilitation for Upper Limb Function in Myotonic Dystrophy Type 1
Acronym
Technorehab
Official Title
Technology Assisted Rehabilitation for Upper Limb Function in Myotonic Dystrophy Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Oslo University Hospital, Vikersund Rehabilitation Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myotonic Dystrophy Type 1 (DM1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single subject experimental design (SSED) study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technorehab
Arm Type
Experimental
Arm Description
Rehabilitation using Tyromotion Amadeo and Armeo Senso
Intervention Type
Device
Intervention Name(s)
Tyromotion Amadeo and Armeo Senso
Intervention Description
Robot assisted rehabilitation for arm- and hand function with Tyromotion Amadeo and Armeo Senso
Primary Outcome Measure Information:
Title
Fine motor skill dexterity test, 9 hole peg test (9HPT)
Description
Motor skill test
Time Frame
1-3 minutes
Secondary Outcome Measure Information:
Title
Range of motion (ROM)
Description
Measure of ROM in upper limb joints
Time Frame
5-10 minutes
Title
Nut and Bolt test
Description
Motor skill test
Time Frame
5 minutes
Title
Hand strength
Description
Measured by Jamar digital dynamometer
Time Frame
5 minutes
Title
Pinch Gauge
Description
Finger strength measures by Jamar digital pinch gauge
Time Frame
5 minutes
Other Pre-specified Outcome Measures:
Title
Abilhand
Description
Patient reported outcome measure, measure of manual ability for adults with upper limb impairment
Time Frame
5 minutes
Title
Myotonia behavior scale
Description
Patient reported outcome measure
Time Frame
1-5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilde Stendal Robinson, PhD
Phone
+47 90607081
Email
h.s.robinson@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne Ludt Fossmo, MSc
Phone
+47 93630606
Email
halufo@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilde Stendal Robinson, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vikersund Rehabilitation Center
City
Vikersund
State/Province
Viken
ZIP/Postal Code
3370
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne Ludt Fossmo, Master
Phone
+4793630606
Email
hanne.fossmo@vikersunbad.no

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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