MOdularity for SEnsory Motor Control

NCT03530358 | Unknown

• 2 other identifiers: 2015.1416/GR-2011-02348942
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

For this project the investigators ask, how the activation and organization of muscle synergies may be disrupted by brain lesions, and whether it is possible to modify synergy activations by means of specific therapies. Will be investigated whether there is a relationship between post-stroke cortical plasticity and changes in synergy activations due to a therapy.

Conditions

Stroke, Ischemic; Upper Limb Injury; Rehabilitation

Keywords

Muscle Synergies; MRI; Virtual Reality; Robotics

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment Scale - Upper Extremity (construct: upper limb motor function)

  Scale range scores: 0 - 66 points. Total summed score is reported with higher values representing a better outcome.

  20 days

Secondary Outcomes (7)

• Functional Independence Measure (FIM) (construct: measure for independence in the activities of daily living - ADLs)

  20 days

• Fugl-Meyer Assessment Scale - Range of Motion of Joints (construct: measure joints' passive range of motion)

  20 days

• Fugl-Meyer Assessment Scale - Sensory Function (construct: measure of residual sensory function in upper and lower limbs affected by paresis)

  20 days

• Fugl-Meyer Assessment Scale - Balance (construct: measure of impairment of standing and balance functions)

  20 days

• Reaching Performance Scale (construct: measure of the ability to reach targets in the frontal space of upper limb affected by paresis)

  20 days

Other Outcomes (4)

• Mean duration [s]

  20 days

• Mean velocity [cm/s]

  20 days

• Smoothness [number of submovements]

  20 days

Study Arms (2)

Technology-aided rehabilitation

EXPERIMENTAL

The technology-aided upper limb rehabilitation include reinforced feedback in virtual environment (RFVE), or robotic therapy.

Device: Technology-aided rehabilitation

Conventional rehabilitation

ACTIVE COMPARATOR

The conventional upper limb rehabilitation program will be based on traditional rehabilitation techniques aimed at restoring upper limb motor functions.

Behavioral: Conventional rehabilitation

Interventions

Technology-aided rehabilitation DEVICE

VRRS involves performing different kinds of motor tasks with the patient holding a real manipulable object in their hands while interacting with a virtual scenario. "Braccio di Ferro" task consists in center-out reaching movements and return. The subject is required to start from a central target, reach one of five peripheral targets arranged on a semi-circle with a 20 cm radius and then return to the central target.

Also known as: Virtual Reality Rehabilitation System (VRRS), Braccio di Ferro

Technology-aided rehabilitation

Conventional rehabilitation BEHAVIORAL

The patients will be asked to perform a wide range of exercises, including: shoulder flexion-extension, abduction-adduction, internal-external rotation, circumduction, elbow flexion-extension, forearm pronation-supination, hand-digit motion. Standardized instructions and modalities will be followed when providing exercises to the patients in order to control for any variability in leading the therapy session due to the therapist.

Conventional rehabilitation

Eligibility Criteria

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

You may qualify if:

• diagnosis of first stroke;
• a score between 1 and 3 (included) at the upper limb sub-item on the Italian version of the National Institute of Health stroke scale (IT - NIHSS) (Pezzella et al., 2009)
• a score higher than 6 out of 66 on the Fugl - Meyer upper extremity (F-M UE) scale (Fugl-Meyer et al., 1975).

You may not qualify if:

• the presence of a moderate cognitive decline defined as a Mini Mental State Examination (Folstein et al., 1975) score \< 20/30 points;
• the finding of severe verbal comprehension deficit defined as a number of errors \> 13 (Tau Points \< 58/78) on the Token Test (Huber et al., 1984);
• evidence of apraxia and visuospatial neglect interfering with upper arm movements and manipulation of simple objects in all the directions within the visual field, as assessed through neurological examination;
• report in the patient's clinical history or evidence from the neurological examination of behavioural disturbances (i.e. delusions, aggressiveness and severe apathy/depression) that could affect compliance with the rehabilitation programs;
• non stabilised fractures;
• diagnosis of depression/delusion;
• associated traumatic brain injury;
• drug resistant epilepsy;
• evidence of ideomotor apraxia;
• evidence of visuospatial neglect;
• severe impairment of verbal comprehension defined as a score higher than 13 errors on Token test (i.e. score\<58 out of 78 Tau points).

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (2)

IRCCS Fondazione Don Gnocchi Onlus

Milan, Italy

Location

IRCCS San Camillo, Venezia, Italy

Venice, 30126, Italy

Location

Related Publications (28)

• Saltiel P, Wyler-Duda K, D'Avella A, Tresch MC, Bizzi E. Muscle synergies encoded within the spinal cord: evidence from focal intraspinal NMDA iontophoresis in the frog. J Neurophysiol. 2001 Feb;85(2):605-19. doi: 10.1152/jn.2001.85.2.605.

  PMID: 11160497 BACKGROUND

• d'Avella A, Portone A, Fernandez L, Lacquaniti F. Control of fast-reaching movements by muscle synergy combinations. J Neurosci. 2006 Jul 26;26(30):7791-810. doi: 10.1523/JNEUROSCI.0830-06.2006.

  PMID: 16870725 BACKGROUND

• Weiss T, Miltner WH, Liepert J, Meissner W, Taub E. Rapid functional plasticity in the primary somatomotor cortex and perceptual changes after nerve block. Eur J Neurosci. 2004 Dec;20(12):3413-23. doi: 10.1111/j.1460-9568.2004.03790.x.

  PMID: 15610174 BACKGROUND

• Cheung VC, Piron L, Agostini M, Silvoni S, Turolla A, Bizzi E. Stability of muscle synergies for voluntary actions after cortical stroke in humans. Proc Natl Acad Sci U S A. 2009 Nov 17;106(46):19563-8. doi: 10.1073/pnas.0910114106. Epub 2009 Oct 30.

  PMID: 19880747 BACKGROUND

• Cheung VC, Turolla A, Agostini M, Silvoni S, Bennis C, Kasi P, Paganoni S, Bonato P, Bizzi E. Muscle synergy patterns as physiological markers of motor cortical damage. Proc Natl Acad Sci U S A. 2012 Sep 4;109(36):14652-6. doi: 10.1073/pnas.1212056109. Epub 2012 Aug 20.

  PMID: 22908288 BACKGROUND

• Mehrholz J, Hadrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3.

  PMID: 22696362 BACKGROUND

• Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008349. doi: 10.1002/14651858.CD008349.pub2.

  PMID: 21901720 BACKGROUND

• Carpinella I, Cattaneo D, Abuarqub S, Ferrarin M. Robot-based rehabilitation of the upper limbs in multiple sclerosis: feasibility and preliminary results. J Rehabil Med. 2009 Nov;41(12):966-70. doi: 10.2340/16501977-0401.

  PMID: 19841825 BACKGROUND

• Carpinella I, Cattaneo D, Bertoni R, Ferrarin M. Robot training of upper limb in multiple sclerosis: comparing protocols with or without manipulative task components. IEEE Trans Neural Syst Rehabil Eng. 2012 May;20(3):351-60. doi: 10.1109/TNSRE.2012.2187462.

  PMID: 22623407 BACKGROUND

• Sacco RL, Wolf PA, Bharucha NE, Meeks SL, Kannel WB, Charette LJ, McNamara PM, Palmer EP, D'Agostino R. Subarachnoid and intracerebral hemorrhage: natural history, prognosis, and precursive factors in the Framingham Study. Neurology. 1984 Jul;34(7):847-54. doi: 10.1212/wnl.34.7.847.

  PMID: 6539860 BACKGROUND

• Pezzella FR, Picconi O, De Luca A, Lyden PD, Fiorelli M. Development of the Italian version of the National Institutes of Health Stroke Scale: It-NIHSS. Stroke. 2009 Jul;40(7):2557-9. doi: 10.1161/STROKEAHA.108.534495. Epub 2009 Jun 11.

  PMID: 19520997 BACKGROUND

• Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. No abstract available.

  PMID: 3503663 BACKGROUND

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

  PMID: 1135616 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Huber W, Poeck K, Willmes K. The Aachen Aphasia Test. Adv Neurol. 1984;42:291-303. No abstract available.

  PMID: 6209953 BACKGROUND

• Lee DD, Seung HS. Learning the parts of objects by non-negative matrix factorization. Nature. 1999 Oct 21;401(6755):788-91. doi: 10.1038/44565.

  PMID: 10548103 BACKGROUND

• Inzitari D, Carlucci G. Italian Stroke Guidelines (SPREAD): evidence and clinical practice. Neurol Sci. 2006 Jun;27 Suppl 3:S225-7. doi: 10.1007/s10072-006-0622-y.

  PMID: 16752053 BACKGROUND

• Bamford J, Sandercock P, Dennis M, Burn J, Warlow C. Classification and natural history of clinically identifiable subtypes of cerebral infarction. Lancet. 1991 Jun 22;337(8756):1521-6. doi: 10.1016/0140-6736(91)93206-o.

  PMID: 1675378 BACKGROUND

• Arya KN, Verma R, Garg RK. Estimating the minimal clinically important difference of an upper extremity recovery measure in subacute stroke patients. Top Stroke Rehabil. 2011 Oct;18 Suppl 1:599-610. doi: 10.1310/tsr18s01-599.

  PMID: 22120029 BACKGROUND

• Piron L, Turolla A, Agostini M, Zucconi C, Tonin P, Piccione F, Dam M. Assessment and treatment of the upper limb by means of virtual reality in post-stroke patients. Stud Health Technol Inform. 2009;145:55-62.

  PMID: 19592786 BACKGROUND

• Piron L, Turolla A, Agostini M, Zucconi CS, Ventura L, Tonin P, Dam M. Motor learning principles for rehabilitation: a pilot randomized controlled study in poststroke patients. Neurorehabil Neural Repair. 2010 Jul-Aug;24(6):501-8. doi: 10.1177/1545968310362672.

  PMID: 20581337 BACKGROUND

• 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

• Casadio M, Sanguineti V, Morasso PG, Arrichiello V. Braccio di Ferro: a new haptic workstation for neuromotor rehabilitation. Technol Health Care. 2006;14(3):123-42.

  PMID: 16971753 BACKGROUND

• Bohannon RW, Andrews AW. Interrater reliability of hand-held dynamometry. Phys Ther. 1987 Jun;67(6):931-3. doi: 10.1093/ptj/67.6.931.

  PMID: 3588679 BACKGROUND

• Lencioni T, Fornia L, Bowman T, Marzegan A, Caronni A, Turolla A, Jonsdottir J, Carpinella I, Ferrarin M. A randomized controlled trial on the effects induced by robot-assisted and usual-care rehabilitation on upper limb muscle synergies in post-stroke subjects. Sci Rep. 2021 Mar 5;11(1):5323. doi: 10.1038/s41598-021-84536-8.

  PMID: 33674675 RESULT

• Cheung VC, Devarajan K, Severini G, Turolla A, Bonato P. Decomposing time series data by a non-negative matrix factorization algorithm with temporally constrained coefficients. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:3496-9. doi: 10.1109/EMBC.2015.7319146.

  PMID: 26737046 RESULT

• Turolla A, Venneri A, Farina D, Cagnin A, Cheung VCK. Rehabilitation Induced Neural Plasticity after Acquired Brain Injury. Neural Plast. 2018 May 10;2018:6565418. doi: 10.1155/2018/6565418. eCollection 2018. No abstract available.

  PMID: 29861717 RESULT

• Carpinella I, Lencioni T, Bowman T, Bertoni R, Turolla A, Ferrarin M, Jonsdottir J. Effects of robot therapy on upper body kinematics and arm function in persons post stroke: a pilot randomized controlled trial. J Neuroeng Rehabil. 2020 Jan 30;17(1):10. doi: 10.1186/s12984-020-0646-1.

  PMID: 32000790 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Arm Injuries

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Andrea Turolla, PhD

  IRCCS San Camillo, Venezia, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A simple random number sequence will be generated by a computer and the allocation concealment will be guaranteed using sequentially numbered, opaque sealed envelopes. The therapists responsible for randomization and allocation procedures will be independent of the blind therapists and medical doctors involved in patients' screening and treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

IT (2)