NCT03561155

Brief Summary

The upper limb (UL) plays an important role in the daily functioning of patients with Multiple Sclerosis (MS) and negatively influences their quality of life. Effective arm-hand training programs are needed. Various robotic systems have been developed for UL rehabilitation, mainly used in patients with stroke. Preliminary work in MS has focused on proximal sections of the arm. No study has evaluated the use of robotics for improving manual dexterity and their effects on cortical activity. The results of this research project could be relevant for the advancement of knowledge about UL functional recovery in individuals with MS and to determine the pattern of muscle activation underlying functional recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

May 23, 2018

Last Update Submit

June 18, 2018

Conditions

Multiple SclerosisRehabilitation

Keywords

Upper ExtremityRecovery

Outcome Measures

Primary Outcomes (1)

  • Action Research Arm test

    Assesses upper limb functioning using observational methods

    Up to 6 weeks

Secondary Outcomes (10)

  • Fugl-Meyer Assessment Motor Scale - Arm Section

    Up to 6 weeks

  • Motor Activity Log

    Up to 6 weeks

  • Tremor Severity Scale

    Up to 6 weeks

  • Nine Hole Peg Test

    Up to 6 weeks

  • Motricity Index

    Up to 6 weeks

  • +5 more secondary outcomes

Study Arms (2)

Robot assisted treatment

EXPERIMENTAL

The experimental group (EG) will undergo a robot-assisted arm training using Amadeo® (Tyromotion-Austria).

Device: Robot assisted treatment (Amadeo®)

Conventional treatment

ACTIVE COMPARATOR

The conventional group (CG) will undergo robot unassisted treatment (Conventional treatment).

Other: Conventional treatment

Interventions

Robot assisted treatment (Amadeo®)DEVICE

The protocol will consist of exercises as follows: passive modality , passive/plus modality , assisted therapy and Balloon.

Also known as: Robot assisted treatment
Robot assisted treatment
Conventional treatmentOTHER

The protocol will consist of exercises as follow: upper limb mobilization, facilitation of movements and active tasks. The exercises will be focused on improving muscle strength, finger extension and flexion and motor control

Conventional treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-65 years
  • EDSS score\<8
  • Mini Mental State Evaluation (MMSE) score\>24
  • Ashworth Scale Score\<2 evaluated at the elbow, wrist and fingers
  • Nine Hole Peg Test (NHPT) score \>30 sec.

You may not qualify if:

  • Disease recurrence that worsened significantly during the 3 months prior to recruitment
  • Medical therapy not well defined
  • Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program
  • Severe visual dysfunction
  • Performance of any type of rehabilitation treatment in the month prior to recruitment
  • Other concomitant neurological or orthopaedic diseases involving the UL and interfering with their function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOC Neurorehabilitation

Verona, 37134, Italy

Location

Related Publications (1)

  • Gandolfi M, Vale N, Dimitrova EK, Mazzoleni S, Battini E, Benedetti MD, Gajofatto A, Ferraro F, Castelli M, Camin M, Filippetti M, De Paoli C, Chemello E, Picelli A, Corradi J, Waldner A, Saltuari L, Smania N. Effects of High-intensity Robot-assisted Hand Training on Upper Limb Recovery and Muscle Activity in Individuals With Multiple Sclerosis: A Randomized, Controlled, Single-Blinded Trial. Front Neurol. 2018 Oct 24;9:905. doi: 10.3389/fneur.2018.00905. eCollection 2018.

    PMID: 30405526DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nicola Smania, Professor

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 19, 2018

Study Start

November 1, 2014

Primary Completion

September 1, 2017

Study Completion

May 1, 2018

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations

IT(1)