Technology Assisted Rehabilitation for Upper Limb Function in Myotonic Dystrophy Type 1 (Technorehab)
May 13, 2024 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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
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
- 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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
Sponsor
Investigators
- Principal Investigator: Hilde Stendal Robinson, PhD, University of Oslo
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 (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
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
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.