Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients

Cardiovascular Diseases Clinical Trial

Official title:

Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients: Clinical and Gait Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805009
• Other study ID #: RP 15/13
• Status: Completed
• Phase: N/A
• Start date: March 19, 2013
• Est. completion date: September 30, 2018

Study information

• Verified date: June 2023
• Source: IRCCS San Raffaele Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To date, no studies seems to compare conventional gait rehabilitation program with end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics beyond clinical multi prospective outcomes. The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program.

Description:

To evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program, patients following first ever stroke in sub-acute phase will be recruited and assessed both clinically and instrumentally (Gait Analysis) at baseline (T0) and at the end of training program (T1). The patients will be divided into 2 groups and will conduct two different types of gait training: one group will be recruited by IRCCS San Raffaele Pisana of Rome and will perform, in addition to conventional therapy, gait training using an end-effector robotic device for RAGT(Robotic Group, RG); and another group will be recruited by the Don Carlo Gnocchi Foundation Onlus of Rome, and will perform conventional gait rehabilitation program(Conventional Group, CG).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• first cerebral stroke
• 2 weeks up to 6 months post the acute event (subacute patients)
• age between 18-80 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

Exclusion Criteria:

• 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 Written informed consent was obtained from each subject.

Related Conditions & MeSH terms

• Acute Stroke
• Brain Diseases
• Cardiovascular Diseases
• Central Nervous System Diseases
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Mild Stroke
• Nervous System Diseases
• Severe Stroke
• Stroke

Intervention

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).

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi Onlus	Rome	RM
Italy	IRCCS San Raffaele Pisana	Rome	RM

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma	Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (23)

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. — View Citation

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Cho DY, Park SW, Lee MJ, Park DS, Kim EJ. Effects of robot-assisted gait training on the balance and gait of chronic stroke patients: focus on dependent ambulators. J Phys Ther Sci. 2015 Oct;27(10):3053-7. doi: 10.1589/jpts.27.3053. Epub 2015 Oct 30. — View Citation

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Dundar U, Toktas H, Solak O, Ulasli AM, Eroglu S. A comparative study of conventional physiotherapy versus robotic training combined with physiotherapy in patients with stroke. Top Stroke Rehabil. 2014 Nov-Dec;21(6):453-61. doi: 10.1310/tsr2106-453. — View Citation

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. — View Citation

Gandolfi M, Geroin C, Picelli A, Munari D, Waldner A, Tamburin S, Marchioretto F, Smania N. Robot-assisted vs. sensory integration training in treating gait and balance dysfunctions in patients with multiple sclerosis: a randomized controlled trial. Front Hum Neurosci. 2014 May 22;8:318. doi: 10.3389/fnhum.2014.00318. eCollection 2014. — View Citation

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Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8. Erratum In: Stroke.2008 Aug;39(8): e143. — View Citation

Kelley CP, Childress J, Boake C, Noser EA. Over-ground and robotic-assisted locomotor training in adults with chronic stroke: a blinded randomized clinical trial. Disabil Rehabil Assist Technol. 2013 Mar;8(2):161-8. doi: 10.3109/17483107.2012.714052. Epub 2012 Sep 20. — View Citation

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. — View Citation

Li L, Ding L, Chen N, Mao Y, Huang D, Li L. Improved walking ability with wearable robot-assisted training in patients suffering chronic stroke. Biomed Mater Eng. 2015;26 Suppl 1:S329-40. doi: 10.3233/BME-151320. — View Citation

Lonini L, Shawen N, Scanlan K, Rymer WZ, Kording KP, Jayaraman A. Accelerometry-enabled measurement of walking performance with a robotic exoskeleton: a pilot study. J Neuroeng Rehabil. 2016 Mar 31;13:35. doi: 10.1186/s12984-016-0142-9. — View Citation

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. — View Citation

Mehrholz J, Pohl M. Electromechanical-assisted gait training after stroke: a systematic review comparing end-effector and exoskeleton devices. J Rehabil Med. 2012 Mar;44(3):193-9. doi: 10.2340/16501977-0943. — View Citation

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. — View Citation

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Palmieri L, Barchielli A, Cesana G, de Campora E, Goldoni CA, Spolaore P, Uguccioni M, Vancheri F, Vanuzzo D, Ciccarelli P, Giampaoli S; Research Group of the Project 'Italian National Register of Coronary and Cerebrovascular Events'. The Italian register of cardiovascular diseases: attack rates and case fatality for cerebrovascular events. Cerebrovasc Dis. 2007;24(6):530-9. doi: 10.1159/000110423. Epub 2007 Oct 29. — View Citation

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Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0. — View Citation

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. — View Citation

Taveggia G, Borboni A, Mule C, Villafane JH, Negrini S. Conflicting results of robot-assisted versus usual gait training during postacute rehabilitation of stroke patients: a randomized clinical trial. Int J Rehabil Res. 2016 Mar;39(1):29-35. doi: 10.1097/MRR.0000000000000137. — View Citation

Winter DA. Biomechanics and motor control of human movement. John Wiley & Sons, 2009.

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait Analysis	Kinematic and kinetic gait parameters will be calculated from data acquired with a motion capture system (SMART-DX; BTSBioengneering, Italy).	Session 1 (baseline), and Session 20 (week 7)
Other	Postural Analysis	Posturographic parameters will be obtained from the analysis of the center of pressure (COP) trajectories measured by force platforms during standing in both open and closed eyes conditions.	Session 1 (baseline), and Session 20 (week 7)
Primary	Change in Six-Minute Walking Test (6MWT)	The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded. This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea.	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in Fugl-Meyer Assessment (FMA) scale	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total: Motor functioning (the score ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.; Sensory functioning (from 0 to 24 points); Balance (from 0 to 14); Joint range of motion (from 0 to 44); Joint pain (from 0 to 44 ) Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in Motricity Index (MI)	The MI aims to evaluate lower limb motor impairment after stroke, administrated on both sides.; Items to assess the lower limbs are 3, scoring from 0 to 33 each: (1) ankle dorsiflexion with foot in a plantar flexed position (2) knee extension with the foot unsupported and the knee at 90° (3) hip flexion with the hip at 90° moving the knee as close as possible to the chin. (no movement: 0, palpable flicker but no movement: 9, movement but not against gravity :14, movement against gravity movement against gravity: 19, movement against resistance: 25, normal:33)	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in Modified Ashworth Scale (MAS)	The MAS is a 6 point ordinal scale used for grading hypertonia in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in Tinetti Scale Balance (TIN-B)	Scales to measure activity ICF domain.	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in Tinetti Walking (TIN-W)	Scales to measure activity ICF domain.	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in Functional Ambulation Classification (FAC)	Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in Trunk Control Test (TCT)	The TCT assesses the motor impairment in stroke patients and it's correlated with eventual walking ability. Testing is done with the patient lying on a bed: (1) roll to weak side. (2) roll to strong side. (3) balance in sitting position on the edge of the bed with the feet off the ground for at least 30. (4) sit up from lying down. Total score: 0-100	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in 10 Meter Walk Test (10MWT)	This test will assess the patient's speed during gait. Patients will be asked to walk at their preferred maximum and safe speed. Patients will be positioned 1 meter before the start line and instructed to walk 10 meters, and pass the end line approximately 1 meter after. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be measured using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 s). The test will be recorded 3 times, with adequate rests between them. The average of the 3 times should be recorded.	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in Time Up And Go (TUG)	The Time Up And Go is a test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leant against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible. Time will be measured using a chronometer.	Session 1 (baseline), and Session 20 (week 7)
Secondary	Change in Walking Handicap Scale (WHS)	The Walking Handicap Scale is a classification of 6 functional walking categories, considered as a participation category of the ICF because of its 3 items referred to community ambulation. The score ranges from 1 to 6, and do higher values represent a better outcome.	Session 1 (baseline), and Session 20 (week 7)