Robotic Rehabilitation and Cognitive Functions

NCT04164381 | Completed

• 1 other identifier: FDGCOG_19
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

A recent multicenter study of the Fondazione Don Gnocchi (FDG) Robotic Rehabilitation Group (NCT02879279) showed the efficacy of robotic rehabilitation in upper limb motor recovery after stroke using a set of robots and sensor-based devices. In clinical practice, beside sensory-motor deficits, stroke patients often present concomitant cognitive impairments (as attention and memory disorders). The robotic and technological systems used in the above-mentioned study allow training on some cognitive functions such as visual memory, visual-spatial functions and working memory, as well as motor training of the upper limb. The aim of the study is to assess whether cognitive functions, such as visual memory, visual-spatial skills and working memory (evaluated with specific tests) improve after robotic therapy of the upper limb in subacute stroke patients.

Conditions

Stroke

Keywords

Rehabilitation; Robotics; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Change in Symbol Digit Modalities Test (SDMT)

  SDMT evaluates information processing speed. It consists of a simple task of replacing symbols with numbers. Using a reference key, the patient has 90 seconds to match a sequence of symbols with the correspondent numbers as rapidly as possible. Both written or oral administration can be used. For each correct answer, a point is assigned.

  Baseline (T0), Treatment (6 weeks) (T1)

Secondary Outcomes (4)

• Tower of London (TOL)

  Baseline (T0), Treatment (6 weeks) (T1)

• Change in Rey-Osterrieth Complex Figure Test (ROCF).

  Baseline (T0), Treatment (6 weeks) (T1)

• Change in Digit Span (DS)

  Baseline (T0), Treatment (6 weeks) (T1)

• Change in Stroop and Color Word test (SCWT)

  Baseline (T0), Treatment (6 weeks) (T1)

Other Outcomes (3)

• Change in Motricity Index (MI)

  Baseline (T0), Treatment (6 weeks) (T1)

• Change in Modified Barthel Index (BI)

  Baseline (T0), Treatment (6 weeks) (T1)

• Change in Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity portion (FMA-UL)

  Baseline (T0), Treatment (6 weeks) (T1)

Study Arms (1)

Robotic assisted intervention

EXPERIMENTAL

Upper limb robotic therapy using a set of robotic and sensor based devices and exercises specifically selected to train cognitive functions.

Device: Robotic assisted intervention

Interventions

Robotic assisted intervention DEVICE

Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.

Robotic assisted intervention

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first ischemic or hemorrhagic stroke (verified by MRI or CT);
• time latency within 6 months from stroke (subacute patients);
• age between 35-85 years;
• cognitive abilities adequate to understand the experiments and the follow instructions Token test ≥26.5 (correction as for age and school level);
• upper limb impairment (FMA score ≤58);
• ability to give written consent;
• compliance with the study procedures.

You may not qualify if:

• history of recurrent stroke;
• inability to understand the instructions required for the study;
• fixed contraction in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
• severe deficits in visual acuity.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Don Gnocchi Foundation

Rome, 00168, Italy

Location

Related Publications (8)

• Aprile I, Germanotta M, Cruciani A, Loreti S, Pecchioli C, Cecchi F, Montesano A, Galeri S, Diverio M, Falsini C, Speranza G, Langone E, Papadopoulou D, Padua L, Carrozza MC; FDG Robotic Rehabilitation Group. Upper Limb Robotic Rehabilitation After Stroke: A Multicenter, Randomized Clinical Trial. J Neurol Phys Ther. 2020 Jan;44(1):3-14. doi: 10.1097/NPT.0000000000000295.

  PMID: 31834217 BACKGROUND

• 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. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

  PMID: 30175845 BACKGROUND

• Aprile I, Cruciani A, Germanotta M, Gower V, Pecchioli C, Cattaneo D, Vannetti F, Padua L, Gramatica F. Upper Limb Robotics in Rehabilitation: An Approach to Select the Devices, Based on Rehabilitation Aims, and Their Evaluation in a Feasibility Study. Applied Sciences 2019, 9(18), 3920; https://doi.org/10.3390/app9183920

  BACKGROUND

• Rodgers H, Bosomworth H, Krebs HI, van Wijck F, Howel D, Wilson N, Aird L, Alvarado N, Andole S, Cohen DL, Dawson J, Fernandez-Garcia C, Finch T, Ford GA, Francis R, Hogg S, Hughes N, Price CI, Ternent L, Turner DL, Vale L, Wilkes S, Shaw L. Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial. Lancet. 2019 Jul 6;394(10192):51-62. doi: 10.1016/S0140-6736(19)31055-4. Epub 2019 May 22.

  PMID: 31128926 BACKGROUND

• Rogers JM, Duckworth J, Middleton S, Steenbergen B, Wilson PH. Elements virtual rehabilitation improves motor, cognitive, and functional outcomes in adult stroke: evidence from a randomized controlled pilot study. J Neuroeng Rehabil. 2019 May 15;16(1):56. doi: 10.1186/s12984-019-0531-y.

  PMID: 31092252 BACKGROUND

• Faria AL, Cameirao MS, Couras JF, Aguiar JRO, Costa GM, Bermudez I Badia S. Combined Cognitive-Motor Rehabilitation in Virtual Reality Improves Motor Outcomes in Chronic Stroke - A Pilot Study. Front Psychol. 2018 May 30;9:854. doi: 10.3389/fpsyg.2018.00854. eCollection 2018.

  PMID: 29899719 BACKGROUND

• Perez-Marcos D, Bieler-Aeschlimann M, Serino A. Virtual Reality as a Vehicle to Empower Motor-Cognitive Neurorehabilitation. Front Psychol. 2018 Nov 2;9:2120. doi: 10.3389/fpsyg.2018.02120. eCollection 2018.

  PMID: 30450069 BACKGROUND

• Aprile I, Guardati G, Cipollini V, Papadopoulou D, Mastrorosa A, Castelli L, Monteleone S, Redolfi A, Galeri S, Germanotta M. Robotic Rehabilitation: An Opportunity to Improve Cognitive Functions in Subjects With Stroke. An Explorative Study. Front Neurol. 2020 Nov 19;11:588285. doi: 10.3389/fneur.2020.588285. eCollection 2020.

  PMID: 33329334 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Irene Aprile, MD, PhD

  Fondazione Don Carlo Gnocchi Onlus

  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: M.D., Ph,D, Principal Investigator, Head of Rehabilitation Unit

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: November 18, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)