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

NCT04364490 | Completed

• 1 other identifier: ISA COP062017
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

stroke; Gait Rehabilitation; Visual feedback; sensor feedback

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• To evaluate the effectiveness of a novel computerized BWS sensory feedback system (Copernicus®).

  6 weeks after the end of treatment

Study Arms (3)

Experimental VF group

EXPERIMENTAL

Inpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute. The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform advanced gait training sessions by the computerized BWS system without visual feedback; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation.

Device: Copernicus noVF

Experimental VF+ group

EXPERIMENTAL

Inpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute. The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform the same advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation.

Device: Copernicis VF-Plus

Control group

ACTIVE COMPARATOR

Inpatients with a diagnosis of first-ever ischemic stroke in post acute phase, admitted for rehabilitation to S.Anna rehabilitation Institute. The intervention consist of 2-h of rehabilitation daily sessions, five weekly over 6 weeks. During one hour of treatment, this group perform conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation; during second hour of treatment, during the second hour of treatment patients are treated according to conventional therapy consisting of exercises for passive and active mobilization of lower limbs, trunk control, standing, deambulation.

Other: Control group

Interventions

Copernicus noVF DEVICE

Advanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback.

Experimental VF group

Copernicis VF-Plus DEVICE

Advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance.

Experimental VF+ group

Control group OTHER

Usual care

Control group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.Anna Rehabilitation Institute: lead

Study Sites (1)

S.Anna Institute

Crotone, 88900, Italy

Location

Related Publications (11)

• Elsner B, Scholer 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.

  PMID: 31237045 BACKGROUND

• 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.

  PMID: 30375325 BACKGROUND

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

  PMID: 28815562 BACKGROUND

• 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:STROKEAHA.117.018018. doi: 10.1161/STROKEAHA.117.018018. Online ahead of print. No abstract available.

  PMID: 28626059 BACKGROUND

• 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.

  PMID: 29324509 BACKGROUND

• 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.

  PMID: 31519458 BACKGROUND

• 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.

  PMID: 22165907 BACKGROUND

• 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.

  PMID: 24505342 BACKGROUND

• 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.

  PMID: 32035812 RESULT

• 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.2019.104685. eCollection 2019 Dec.

  PMID: 31737755 RESULT

• 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. eCollection 2018.

  PMID: 30065642 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Paolo Tonin, MD

  S.Anna Rehabilitation Insitute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Physicians (carrying out the clinical baseline assessment \[T0\] and post-treatment investigation \[T1\]), as well as, the primary researcher and data entry assistants were all blinded to the group membership of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biomedical Engineer

Model Details: After a stroke this ability may become worse or completely lost. It was demonstrated that hemiparetic patients with poor trunk function at admission stayed longer in a rehabilitation ward compared to patients who had better initial trunk function and could walk longer distances with speed at discharge. The reinforcement of trunk exercises in addition to conventional therapy seems to have a beneficial effect on erection station balance and locomotion in post-stroke patients. In the light of current knowledge, early verticalization and reinforcement of trunk exercises improve posture, balance and mobility. In this study, consecutive patients at first ischemic stroke (documented with TAC / RMN) will be evaluated. Patients in the study group will receive 60 minutes of conventional neuromotor rehabilitation treatment and 60 minutes of treatment with Copernicus®. The control group will receive 120 minutes of conventional neuro motor rehabilitation treatment.

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 28, 2020
• Study Start: June 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 1, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)