Rehabilitation Multi Sensory Room for Robot Assisted Functional Movements in Upper-limb Rehabilitation in Chronic Stroke

NCT03208634 | Completed

• 1 other identifier: 0043622/14U
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic rehabilitation is promising to promote function in stroke patients. The assist as needed training paradigm has shown to stimulate neuroplasticity but often cannot be used because stroke patients are too impaired to actively control the robot against gravity. Aim of this study is to present a novel robotic approach based on fully assisted functional movements and to examine the effect of the intervention in terms of motor function improvement in subjects with chronic stroke in the short term and at 6-month follow up. A preliminary evaluation of the effectiveness of the intervention in improving activity and participation in the short term is also performed. Further, the study aims to verify whether some instrumental measures (using kinematics, EMG and EEG) may help gain insight into the mechanisms leading to improved motor ability following the robotic intervention and can be used to predict functional recovery.

Conditions

Chronic Stroke

Keywords

robotics; motor performance; stroke patient; upper limb; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Upper-Extremity Fugl-Meyer Assessment

  Function domain

  Baseline; 4 weeks; 6-month follow up

Secondary Outcomes (2)

• Change in Wolf Motor Function Test (WMFT)

  Baseline; 4 weeks; 6-month follow up

• Change in Motor Activity Log

  Baseline; 4 weeks; 6-month follow up

Other Outcomes (11)

• Change in Modified Research Council

  Baseline; 4 weeks; 6-month follow up

• Change in Modified Ashworth Scale

  Baseline; 4 weeks; 6-month follow up

• Change in The Clinical Global Impression Scale of Severity and Improvement

  Baseline; 4 weeks; 6-month follow up

Study Arms (1)

Robotic intervention

EXPERIMENTAL

Robotic intervention.

Device: Robotic intervention

Interventions

Robotic intervention DEVICE

One-month robotic intervention. Twelve sessions, three sessions a week, 40 minutes each. Twenty minutes of fully assisted reaching + 20 minutes of assisted Hand-to-Mouth

Robotic intervention

Eligibility Criteria

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

You may qualify if:

• hemiplegia after first stroke;
• time from the stroke event \> 6 months;
• absence of severe attentive deficits;
• ability to perform active arm movements (shoulder flexion MRC \> 1 and AROM \> 60°, elbow flexion-extension MRC \>1 and AROM \> 90°) and able to hold the robot handle,
• Modified Ashworth Scale score ≤ 3 (see section outcome)

You may not qualify if:

• other concurrent upper-limb rehabilitation interventions;
• presence of global aphasia and/or cognitive impairments that could interfere with
• understanding the instructions during evaluation and treatment.
• concomitant progressive central nervous system disorders, peripheral nervous system disorders or myopathies

Sponsors & Collaborators

• Villa Beretta Rehabilitation Center: lead
• The National Research Council, Italy: collaborator

Study Sites (1)

Villa Beretta Rehabilitation Center

Costa Masnaga, Lecco, 23845, Italy

Location

Related Publications (5)

• Norouzi-Gheidari N, Archambault PS, Fung J. Effects of robot-assisted therapy on stroke rehabilitation in upper limbs: systematic review and meta-analysis of the literature. J Rehabil Res Dev. 2012;49(4):479-96. doi: 10.1682/jrrd.2010.10.0210.

  PMID: 22773253 RESULT

• Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2015 Nov 7;2015(11):CD006876. doi: 10.1002/14651858.CD006876.pub4.

  PMID: 26559225 RESULT

• Caimmi M, Carda S, Giovanzana C, Maini ES, Sabatini AM, Smania N, Molteni F. Using kinematic analysis to evaluate constraint-induced movement therapy in chronic stroke patients. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):31-9. doi: 10.1177/1545968307302923. Epub 2007 Jun 26.

  PMID: 17595381 RESULT

• Caimmi M, Guanziroli E, Malosio M, Pedrocchi N, Vicentini F, Molinari Tosatti L, Molteni F. Normative Data for an Instrumental Assessment of the Upper-Limb Functionality. Biomed Res Int. 2015;2015:484131. doi: 10.1155/2015/484131. Epub 2015 Oct 11.

  PMID: 26539500 RESULT

• Caimmi M, Giovanzana C, Gasperini G, Molteni F, Molinari Tosatti L. Robot Fully Assisted Upper-Limb Functional Movements Against Gravity to Drive Recovery in Chronic Stroke: A Pilot Study. Front Neurol. 2022 Mar 8;12:782094. doi: 10.3389/fneur.2021.782094. eCollection 2021.

  PMID: 35350582 DERIVED

Study Officials

• Franco Molteni

  Villa Beretta Rehab Center

  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: Clinical Director

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: July 5, 2017
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 5, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)