Robot-based Rehabilitation of Upper Limb Impairment in Multiple Sclerosis

NCT02711566 | Completed

• 1 other identifier: FISM_Robot
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

Robot-assisted therapy has proven effective in the neuromotor rehabilitation of eg stroke survivors. Robots can be programmed to interact with patients by guiding their movements, by monitoring their performance and by quantifying the type and degree of their impairment. A distinctive element of multiple sclerosis is the involvement of a variety of functional systems, in a way that is highly subject-specific. This requires a personalization of treatment, and continuous adaptation to changes in condition. This points to a need for integrating patient assessment, definition of rehabilitation protocols, their administration and the assessment of their outcome. The goal of this study is to assess, in persons with MS, the efficacy of a type of robot-assisted training that was specifically designed to counteract incoordination and muscle weakness (typical of MS), tailored to individual type and degree of impairment, when compared to simple movement training.

Conditions

Multiple Sclerosis

Keywords

Rehabilitation; Robot-assisted therapy

Outcome Measures

Primary Outcomes (1)

• Change of the 9 Hole Peg Test score

  baseline and 4 weeks and baseline and 16 weeks

Secondary Outcomes (3)

• Treatment change in percentage of responders at 9 Hole Peg Test score

  baseline and 4 weeks and baseline and 16 weeks

• Absolute change of exercise performance

  baseline and 4 weeks and baseline and 16 weeks

• Absolute change of task difficulty

  baseline and 4 weeks and baseline and 16 weeks

Study Arms (2)

Sensorimotor training

ACTIVE COMPARATOR

Patients in this arm were assigned to the 'Physioassistant: Haptic training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation. All participating centers used the exact same apparatus and experimental set-up.

Device: Physioassistant: Sensorimotor training

Haptic training

EXPERIMENTAL

Patients in this arm were assigned to the 'Physioassistant: Sensorimotor training' intervention. The treatments were delivered through a planar robotic manipulandum, specifically designed for motor learning studies and robot-assisted rehabilitation. All participating centers used the exact same apparatus and experimental set-up.

Device: Physioassistant: Haptic training

Interventions

Physioassistant: Haptic training DEVICE

Subjects in the Haptic training arm had to perform fast-and-accurate reaching movements in different directions. reaching was mediated by a virtual 'tool', consisting of a virtual point mass (m=5 kg) connected to the subjects' hand through a linear spring (stiffness range: Km=200-500 N/m). An additional spring (stiffness range: Kr = 20-70 N/m) was connected between hand a starting point to resist movements. Subjects were instructed to move the virtual point mass as fast as possible through suitable hand motions, so that the mass ends up and stops on the 'target' area.

Haptic training

Physioassistant: Sensorimotor training DEVICE

Subjects in the Sensorimotor training arm had to perform fast-and-accurate reaching movements in different directions. The manipulandum was only used to record hand movements, but throughout the movement it generated no forces.

Sensorimotor training

Eligibility Criteria

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

You may qualify if:

• definite Multiple sclerosis, stable phase of the disease
• no relapses or worsening \>1 in the Expanded Disability Status Scale in the last three months,
• Expanded Disability Status Scale\<7.5,
• Ashworth score at the upper limb lower than 2,
• Nine-Hole Peg Test between 30 s and 180 s

You may not qualify if:

• previous treatment with robot therapy,
• presence of severe nystagmus,
• visual acuity less than 4/10
• major orthopaedic or other disorders interfering with the protocol

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• University of Genova: collaborator
• Azienda Sanitaria Locale 3 Genovese: collaborator

Related Publications (2)

• Basteris A, De Luca A, Sanguineti V, Solaro C, Mueller M, Carpinella I, Cattaneo D, Bertoni R, Ferrarin M. A tailored exercise of manipulation of virtual tools to treat upper limb impairment in Multiple Sclerosis. IEEE Int Conf Rehabil Robot. 2011;2011:5975509. doi: 10.1109/ICORR.2011.5975509.

  PMID: 22275705 BACKGROUND

• Solaro C, Cattaneo D, Basteris A, Carpinella I, De Luca A, Mueller M, Bertoni R, Ferrarin M, Sanguineti V. Haptic vs sensorimotor training in the treatment of upper limb dysfunction in multiple sclerosis: A multi-center, randomised controlled trial. J Neurol Sci. 2020 May 15;412:116743. doi: 10.1016/j.jns.2020.116743. Epub 2020 Feb 19.

  PMID: 32145522 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Claudio M Solaro, MD

  ASL 3 Genovese

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 17, 2016
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 17, 2016

Record last verified: 2015-05