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

NCT05560438 | Completed

• 1 other identifier: 256361
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Myotonic Dystrophy Type 1 (DM1)

Outcome Measures

Primary Outcomes (1)

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

  Motor skill test

  1-3 minutes

Secondary Outcomes (4)

• Range of motion (ROM)

  5-10 minutes

• Nut and Bolt test

  5 minutes

• Hand strength

  5 minutes

• Pinch Gauge

  5 minutes

Other Outcomes (2)

• Abilhand

  5 minutes

• Myotonia behavior scale

  1-5 minutes

Study Arms (1)

Technorehab

EXPERIMENTAL

Rehabilitation using Tyromotion Amadeo and Armeo Senso

Device: Tyromotion Amadeo and Armeo Senso

Interventions

Tyromotion Amadeo and Armeo Senso DEVICE

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

Technorehab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Granted rehabilitation at Vikersund Rehabilitation center Genetical confirmed myotonic dystrophy diagnosis MIRS score between 2-5

You may not qualify if:

• MIRS score on 1 Reduced Cognitive function and unable to participate in technological rehabilitation and digital evaluation

Sponsors & Collaborators

• University of Oslo: lead
• Oslo University Hospital: collaborator
• Vikersund Rehabilitation Center: collaborator

Study Sites (1)

Vikersund Rehabilitation Center

Vikersund, Akershus, 3370, Norway

Location

MeSH Terms

Conditions

Myotonic Dystrophy

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hilde Stendal Robinson, PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single subject experimental design (SSED) study

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: January 3, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)