Efficacy of End-Effector Robot-Assisted Gait Training Combined With Robotic Balance Training in Subacute Stroke Patients

NCT04162197 | Completed

• 1 other identifier: FDG_GEOHUN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Over the last years, the introduction of robotic technologies in gait rehabilitation of stroke patients has aroused great interest. Some studies have been conducted to evaluate the effects of robot-assisted training compared to conventional gait rehabilitation in patients with subacute stroke but no studies seem to investigate the effects of a combined robotic treatment (gait plus balance). The aim of this study is to evaluate the efficacy of a combined gait and balance robotic rehabilitation compared robotic gait training alone.

Conditions

Stroke

Keywords

Stroke; Robotics; Gait Training; Rehabilitation; Balance; Functional Recovery; Robot-Assisted Gait Training

Outcome Measures

Primary Outcomes (1)

• Change in Berg Balance Scale (BBS)

  The Berg Balance Scale is a widely used clinical test of a person's static and dynamic balance abilities. The test takes 15-20 minutes and comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.

  Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)

Secondary Outcomes (13)

• Change in Motricity Index (MI)

  Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)

• Change in Modified Ashworth Scale (MAS)

  Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)

• Change in Tinetti Scale Balance (TIN-B)

  Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)

• Change in Functional Ambulation Classification (FAC)

  Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)

• Change in 10 Meter Walk Test (10MWT)

  Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)

Other Outcomes (18)

• Gait analysis - Biomechanical data - Step width

  Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)

• Gait analysis - Biomechanical data - Mediolateral distance

  Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)

• Gait analysis - Biomechanical data - Longitudinal distance

  Baseline (T0), Session 12 (4 weeks) (T1), Session 24 (8 weeks ) (T2)

Study Arms (2)

Experimental 1: Gait Group (GG)

EXPERIMENTAL

Gait Group (GG) will perform, in addition to conventional therapy, gait training using only an end effector robotic device for Robot-Assisted Gait Training (RAGT), 3 times/week for 12 sessions/month. During the training, patients will be asked to walk, at a varying speed, for 45 minutes and a partial Body Weight Support (BWS). Participants will start with 30-40% of BWS and an initial speed of 1.5 km/h; increasing to a maximum of between 2.2 and 2.5 km/ h and reducing the initial BWS to 15%. The therapist will provide any help during sessions if required. Over 45 minutes, the patient simulates a minimum of 300 steps; patients could rest during the session, though they will be asked to walk continuously for a minimum of 5 minutes during each session.

Device: GEO

Experimental 2: Balance Group (GHG)

EXPERIMENTAL

Balance Group (GHG) will receive, in addition to conventional therapy, a combined robotic treatment program with the same end-effector robotic system and a robotic proprioceptive platform, 3 times/week for 12 sessions/month. The time of the single session (45 minutes) is dived in gait training and balance training. The balance training will consist in static and dynamic exercises during sitting and standing position, dual-task exercises and exercises aimed to improve trunk control.

Device: GEO and HUNOVA

Interventions

GEO DEVICE

Robot-Assisted Gait Training (RAGT) The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).

Experimental 1: Gait Group (GG)

GEO and HUNOVA DEVICE

Robot-Assisted Gait Training (RAGT) and Balance Training. The Balance Group (GHG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland) and a Balance training using a robotic proprioceptive platform (Hunova - Movendo Technology, Italy).

Experimental 2: Balance Group (GHG)

Eligibility Criteria

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

You may qualify if:

• first cerebral stroke
• month up to 6 months post the acute event (subacute patients)
• age between 18-85 years
• ability to fit into the end-effector footplates
• no significant limitation of joint range of motion
• ability to tolerate upright standing for 60 seconds
• ability to walk unassisted or with little assistance
• ability to give written consent
• compliance with the study procedures

You may not qualify if:

• contractures of the hip, knee, or ankle joints that might limit the range of motion during gait
• medical issue that precludes full weight bearing and ambulation (e.g. orthopaedic injuries, pain, severe osteoporosis, or severe spasticity)
• cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
• cardiac pathologies, anxiety or psychosis that might interfere with the use of the equipment or testing

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Don Gnocchi Foundation

Rome, 00168, Italy

Location

Related Publications (11)

• Aprile I, Iacovelli C, Goffredo M, Cruciani A, Galli M, Simbolotti C, Pecchioli C, Padua L, Galafate D, Pournajaf S, Franceschini M. Efficacy of end-effector Robot-Assisted Gait Training in subacute stroke patients: Clinical and gait outcomes from a pilot bi-centre study. NeuroRehabilitation. 2019;45(2):201-212. doi: 10.3233/NRE-192778.

  PMID: 31498139 BACKGROUND

• Goffredo M, Iacovelli C, Russo E, Pournajaf S, Di Blasi C, Galafate D, Pellicciari L, Agosti M, Filoni S, Aprile I, Franceschini M. Stroke Gait Rehabilitation: A Comparison of End-Effector, Overground Exoskeleton, and Conventional Gait Training. Applied Sciences 9, 2627, 2019. doi:10.3390/app9132627

  BACKGROUND

• Aprile I, Iacovelli C, Padua L, Galafate D, Criscuolo S, Gabbani D, Cruciani A, Germanotta M, Di Sipio E, De Pisi F, Franceschini M. Efficacy of Robotic-Assisted Gait Training in chronic stroke patients: Preliminary results of an Italian bi-centre study. NeuroRehabilitation. 2017;41(4):775-782. doi: 10.3233/NRE-172156.

  PMID: 28946585 RESULT

• Cattaneo D, Carpinella I, Aprile I, Prosperini L, Montesano A, Jonsdottir J. Comparison of upright balance in stroke, Parkinson and multiple sclerosis. Acta Neurol Scand. 2016 May;133(5):346-54. doi: 10.1111/ane.12466. Epub 2015 Aug 3.

  PMID: 26234280 RESULT

• Kim HY, Shin JH, Yang SP, Shin MA, Lee SH. Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial. J Neuroeng Rehabil. 2019 Jul 29;16(1):99. doi: 10.1186/s12984-019-0553-5.

  PMID: 31358017 RESULT

• Swinnen E, Beckwee D, Meeusen R, Baeyens JP, Kerckhofs E. Does robot-assisted gait rehabilitation improve balance in stroke patients? A systematic review. Top Stroke Rehabil. 2014 Mar-Apr;21(2):87-100. doi: 10.1310/tsr2102-87.

  PMID: 24710969 RESULT

• Eng JJ, Tang PF. Gait training strategies to optimize walking ability in people with stroke: a synthesis of the evidence. Expert Rev Neurother. 2007 Oct;7(10):1417-36. doi: 10.1586/14737175.7.10.1417.

  PMID: 17939776 RESULT

• Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.

  PMID: 19608100 RESULT

• Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2017 May 10;5(5):CD006185. doi: 10.1002/14651858.CD006185.pub4.

  PMID: 28488268 RESULT

• Mao YR, Lo WL, Lin Q, Li L, Xiao X, Raghavan P, Huang DF. The Effect of Body Weight Support Treadmill Training on Gait Recovery, Proximal Lower Limb Motor Pattern, and Balance in Patients with Subacute Stroke. Biomed Res Int. 2015;2015:175719. doi: 10.1155/2015/175719. Epub 2015 Nov 16.

  PMID: 26649295 RESULT

• Davis RB, Ounpuu S, Tyburski D, Gage JR. A gait analysis data collection and reduction technique. Hum MovSci 1991; 10: 575-587.

  RESULT

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

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph,D, Principal Investigator, Head of Rehabilitation Unit

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: November 14, 2019
• Study Start: November 18, 2019
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)