Rehabilitative Efficacy of a Visual Feedback Device for Locomotion of Post-stroke Patients

Stroke Clinical Trial

— Copernicus  

Official title:

Study of the Rehabilitative Efficacy of Copernicus®, a Visual Feedback Device for the Early Start to Locomotion of Post-stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364490
• Other study ID #: ISA COP062017
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2020
• Source: S.Anna Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We tested the feasibility and efficacy of a novel body-weight support (BWS) gait training system with visual feedback, called Copernicus®. This computerized device provides highly comfortable, regular and repeatable locomotion in hemiplegic patients, training the ability to transfer weight loading alternately on both feet through visual real-time monitoring of gait parameters.

Description:

Gait disorders are very common in stroke patients (about 80%) increasing the risk of falls in performing daily activities and also reducing the global quality of life. Gait disorders in these patients are characterized by asymmetry in postural and weight distribution during quiet standing, as well as, by reduced gait speed, that is considered one of the most important outcome measure of locomotor recovery.

Restoring gait functions (speed, asymmetry and balance) after stroke is one of the major therapeutic goals in post-stroke rehabilitation and a plethora of recovering strategies have been proposed.

In this study we tested the feasibility and efficacy of a novel body-weight support (BWS) gait training system with visual feedback, called Copernicus®. This computerized device provides highly comfortable, regular and repeatable locomotion in hemiplegic patients, training the ability to transfer weight loading alternately on both feet through visual real-time monitoring of gait parameters Copernicus®, a sensory system for the early start of the locomotion appears as an elliptical cylinder of about 1 meter high on which two completely slideing positions are prepared by means if a guide fixed along the oval surface of the device. Each post has a support on which the patient's healthy side of the subject is placed, above which a brace for the support of the body is attached and weared by the patient in the verticalization; Front of the patient is a tablet that provides visual feedback during the exercises. The patient wears shoes on a pair of soles with piezo-resistive sensors that record for each foot the pressure exerted on the three areas of the foot (outer, inner and heel). The recorded data is then processed and transmitted to the tablet within a virtual reinforcement environment. The patient will be able to know his performance and achieved results and perceive them within a real scenario. The sensing pads measure the support times for each side and the number of changes. The device is so structured as to allow the simultaneous treatment of two patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: December 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• unilateral stroke in the territory of middle cerebral artery, occurring at least 1 month before entry;

• ability to follow verbal instructions without severe cognitive impairment (Mini Mental State Evaluation, MMSE> 24);

• right-handed patients

• signature of informed consent.

Exclusion Criteria:

• bilateral impairment;

• presence of complete hemiplegia;

• history of traumatic injury ( e.g. fracture, joint dislocation with permanent dysmorphism after trauma) impairing the lower limb motor function;

• botulinum toxin injections or other medication influencing the function of the lower limbs;

• history of major affective disorders or alcohol abuse or history and/or clinical evidence of severe heart, lung, kidney, or liver diseases;

• inability to provide informed consent.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Copernicus noVF
Advanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback.
• Copernicis VF-Plus
Advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance.

Other:
• Control group
Usual care

Locations

Country	Name	City	State
Italy	S.Anna Institute	Crotone

Sponsors (1)

Lead Sponsor	Collaborator
S.Anna Rehabilitation Institute

Country where clinical trial is conducted

Italy, 

References & Publications (11)

Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66. Review. — View Citation

Carozzo S, Serra S, Pignolo L, Tonin P, Cerasa A. The assessment of trunk recovery in stroke patients using 3D kinematic measures. Med Eng Phys. 2020 Apr;78:98-105. doi: 10.1016/j.medengphy.2020.01.013. Epub 2020 Feb 5. — View Citation

Cerasa A, Pignolo L, Gramigna V, Serra S, Olivadese G, Rocca F, Perrotta P, Dolce G, Quattrone A, Tonin P. Exoskeleton-Robot Assisted Therapy in Stroke Patients: A Lesion Mapping Study. Front Neuroinform. 2018 Jul 17;12:44. doi: 10.3389/fninf.2018.00044. — View Citation

Elsner B, Schöler A, Kon T, Mehrholz J. Walking with rhythmic auditory stimulation in chronic patients after stroke: A pilot randomized controlled trial. Physiother Res Int. 2020 Jan;25(1):e1800. doi: 10.1002/pri.1800. Epub 2019 Jun 24. — View Citation

Gianella MG, Gath CF, Bonamico L, Olmos LE, Russo MJ. Prediction of Gait without Physical Assistance after Inpatient Rehabilitation in Severe Subacute Stroke Subjects. J Stroke Cerebrovasc Dis. 2019 Nov;28(11):104367. doi: 10.1016/j.jstrokecerebrovasdis.2019.104367. Epub 2019 Sep 10. — View Citation

Mehrholz J, Pohl M, Kugler J, Elsner B. The Improvement of Walking Ability Following Stroke. Dtsch Arztebl Int. 2018 Sep 28;115(39):639-645. doi: 10.3238/arztebl.2018.0639. — View Citation

Mehrholz J, Thomas S, Elsner B. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2017 Aug 17;8:CD002840. doi: 10.1002/14651858.CD002840.pub4. Review. — View Citation

Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-Assisted Training for Walking After Stroke: A Major Update of the Evidence. Stroke. 2017 Jun 16. pii: STROKEAHA.117.018018. doi: 10.1161/STROKEAHA.117.018018. [Epub ahead of print] Review. — View Citation

Pignolo L, Serra S, Basta G, Carozzo S, Arcuri F, Pignataro LM, Ciancarelli I, Tonin P, Cerasa A. Data on a new neurorehabilitation approach targeting functional recovery in stroke patients. Data Brief. 2019 Oct 28;27:104685. doi: 10.1016/j.dib.2019.10468 — View Citation

Price R, Choy NL. Investigating the Relationship of the Functional Gait Assessment to Spatiotemporal Parameters of Gait and Quality of Life in Individuals With Stroke. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):256-264. doi: 10.1519/JPT.0000000000000173. — View Citation

Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.	To assess, motor abilities of lower limb, gait and balance, we use the Tinetti's test.	up to 6 weeks after the end of treatment
Primary	To evaluate the effects of an early rehabilitation and deambulation treatment performed using a visual feedback device.	The degree of disability during activities of daily living was assessed with the Barthel Index (BI).	up to 6 weeks after the end of treatment
Secondary	To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®).	To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®) that provides information on gait performances by visual feedback extracted from wearable sensors we use the Fugl-Meyer Lower Extremities scale test (FM-LE).	6 weeks after the end of treatment