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

NCT ID: NCT05560438

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2023-12-31

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Technorehab

Rehabilitation using Tyromotion Amadeo and Armeo Senso

Group Type: EXPERIMENTAL

Tyromotion Amadeo and Armeo Senso

Intervention Type: DEVICE

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

Interventions

Tyromotion Amadeo and Armeo Senso

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Vikersund Rehabilitation Center

UNKNOWN

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Hilde Stendal Robinson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hilde Stendal Robinson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

Vikersund Rehabilitation Center

Vikersund, Akershus, Norway

Countries

Norway

Other Identifiers

256361

Identifier Type: -

Identifier Source: org_study_id