Stroke Rehabilitation With Exoskeleton-assisted Gait.

NCT03395717 | Completed DMC

• 1 other identifier: RP 10/15
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 4

Brief Summary

Gait recovery is one of the main goals of post-stroke rehabilitation where robotic-assisted practice has shown positive outcomes. However, literature lacks of clinical studies on exoskeleton-supported gait rehabilitation. Recently, a wearable exoskeleton (Ekso™, EksoBionics, USA) has been commercialized for re-enabling patients to stand and walk, involving them directly in steps trigger through body weight balance. The main aim of this study is to assess the clinical and neuromuscular effects of exoskeleton-based gait rehabilitation in sub-acute and chronic stroke patients, compared to patients with similar characteristics who will conduct a traditional over-ground gait training. In this multicentric RCT, 162 stroke patients will be enrolled and randomly assigned to the Experimental Group (EG) or to the Control Group (CG). Patients will conduct at least 12 one-hour-sessions (about 3 times/ week) of Ekso™ (EG) or traditional over-ground (CG) gait rehabilitation. Clinical evaluations (lower limb Modified Ashworth Scale- MAS; Motricity Index - MI; Trunk Control Test - TCT; Functional Ambulation Classification - FAC; 10-meter walking test - 10mwt; 6-minute walking test - 6mwt; Walking Handicap Scale - WHS; Time Up and Go - TUG) will be administered to patients at the beginning (T1) and at the end (T2) of the training period. The primary outcome is the distance performed during the 6mwt. A follow up study at 1 month (T3) and at 3 months (T4) after T2 will be conducted.

Conditions

Severe Stroke; Acute Stroke; Chronic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mild Stroke

Keywords

Stroke; Robot; Hemiparesis; Gait Training; Rehabilitation; Exoskeleton; Functional Recovery

Outcome Measures

Primary Outcomes (1)

• Change in 6 Minute Walk 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), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)

Secondary Outcomes (8)

• Change in 10 Meter Walk Test (10MWT)

  Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)

• Change in Time Up And Go (TUG)

  Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)

• Change in Modified Ashworth Scale (MAS)

  Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)

• Change in Trunk Control Test (TCT)

  Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)

• Change in Motricity Index (MI)

  Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)

Other Outcomes (2)

• Change in Numeric Rating SCale (NRS)

  Session 1 (baseline), Session 12 (week 4)

• Change in surface ElectroMyoGraphy (sEMG)

  Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)

Study Arms (2)

Exoskeleton-Assisted Gait Training

EXPERIMENTAL

Patients conduct sessions of gait training, each lasting 60 minutes, using the powered wearable exoskeleton (Ekso) in addition to conventional therapy. Before the treatment's beginning, a PT checks the correct alignment of the subject's joints with Ekso and the areas of greater pressure between body's skin and device, to set a proper Ekso fit as to customize the padding as well. The best individualized exoskeleton settings should be verified to plan a tailored robotic treatment. During treatment, subjects are trained to interface with the Ekso, with optimal postural arrangement and weight shifting strategies. No strength is required from the patient; only an appropriate balance and weight shifts are necessary to achieve walking, since steps are triggered by the user's lateral weight shift.

Device: Exoskeleton-Assisted Gait Training

Traditional Over ground Gait Training

NO INTERVENTION

The Control Group (CG) performs 60 minutes. lasting sessions of Traditional Over ground Gait Training with a senior PT. In the starting phase, the gait task facilitation is allowed by the Pt's assistance or by using aids, such as walkers, tripods etc. Traditional Over ground Gait Trainings include: * Sit-to-Stand tasks * Exercises for upright position control (right/left load shift): these tasks will allow to include people who are unable to walk in the CG. CG patients will not use any other robots or treadmill for gait training.

Interventions

Exoskeleton-Assisted Gait Training DEVICE

Exoskeleton-Assisted Gait Training

Eligibility Criteria

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

You may qualify if:

• stroke or similar neurological pathologies:
• weeks up to 6 months after the acute event (subacute patients);
• months or more after the acute event (chronic patients)
• age between 18-80 years;
• ability to fit into the device and joint motion which allows gait with it;
• ability to tolerate upright standing for 30 seconds even with upper limbs support;
• sufficient upper extremity strength and balance which allow gait with device;
• ability and willing to give written consent and comply with the study procedures, including the follow-up visits.

You may not qualify if:

• subject's height shorter than 150 cm or taller than 190 cm;
• subject's weight greater than 100 kg;
• contractures of the hip, knee, or ankle joints that might limit normal Range of Motion during gait;
• medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)
• history of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device;
• cognitive and/or communicative disability (e.g. due to brain injury): patients must be able to follow directions and demonstrate learning skills;
• pregnancy ;
• untreated Deep Vein Thrombosis (DVT).

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Ospedale Riabilitativo di Alta Specializzazione Motta Di Livenza -Treviso: collaborator
• Fondazione Centri di Riabilitazione Padre Pio Onlus: collaborator
• Villa Beretta Rehabilitation Center: collaborator
• Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) Foligno - Trevi: collaborator
• IRCCS Sacro Cuore Don Calabria di Negrar: collaborator
• Kos Care - Istituto Santo Stefano Porto Potenza: collaborator
• Kos Care - Istituto Santo Stefano Ancona: collaborator

Study Sites (4)

Villa Beretta

Costa Masnaga, Italy

Location

Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) Trevi

Foligno, Italy

Location

IRCCS San Raffaele Pisana

Roma, I-00163, Italy

Location

Fondazione Centri di Riabilitazione Padre Pio Onlus

San Giovanni Rotondo, Italy

Location

Related Publications (24)

• Franceschini M, Colombo R, Posteraro F, Sale P. A proposal for an Italian minimum data set assessment protocol for robot-assisted rehabilitation: a Delphi study. Eur J Phys Rehabil Med. 2015 Dec;51(6):745-53. Epub 2015 Jul 3.

  PMID: 26138089 BACKGROUND

• Lord SE, McPherson K, McNaughton HK, Rochester L, Weatherall M. Community ambulation after stroke: how important and obtainable is it and what measures appear predictive? Arch Phys Med Rehabil. 2004 Feb;85(2):234-9. doi: 10.1016/j.apmr.2003.05.002.

  PMID: 14966707 BACKGROUND

• Robinson CA, Shumway-Cook A, Ciol MA, Kartin D. Participation in community walking following stroke: subjective versus objective measures and the impact of personal factors. Phys Ther. 2011 Dec;91(12):1865-76. doi: 10.2522/ptj.20100216. Epub 2011 Oct 14.

  PMID: 22003172 BACKGROUND

• Perry J. Analisi del movimento. Elsevier Italia srl, Milano 2005.

  BACKGROUND

• Kandel ER., Schwartz JH., Jessel TM. Fondamenti delle neuroscienze e del comportamento. Casa Editrice Ambrosiana. 1°Ed. 1999.

  BACKGROUND

• Pearson KG. Common principles of motor control in vertebrates and invertebrates. Annu Rev Neurosci. 1993;16:265-97. doi: 10.1146/annurev.ne.16.030193.001405. No abstract available.

  PMID: 8460894 BACKGROUND

• Orlovsky GN. Cerebellum and locomotion. In: Shimamura M, Grillner S, Edgerton VR, eds. Neurobiological Basis of Human Locomotion. Tokyo, Japan: Japan Scientific Societies Press, 1991:187-199.

  BACKGROUND

• Barbeau H, Rossignol S. Recovery of locomotion after chronic spinalization in the adult cat. Brain Res. 1987 May 26;412(1):84-95. doi: 10.1016/0006-8993(87)91442-9.

  PMID: 3607464 BACKGROUND

• Dietz V, Zijlstra W, Duysens J. Human neuronal interlimb coordination during split-belt locomotion. Exp Brain Res. 1994;101(3):513-20. doi: 10.1007/BF00227344.

  PMID: 7851518 BACKGROUND

• Edgerton VR, Tillakaratne NJ, Bigbee AJ, de Leon RD, Roy RR. Plasticity of the spinal neural circuitry after injury. Annu Rev Neurosci. 2004;27:145-67. doi: 10.1146/annurev.neuro.27.070203.144308.

  PMID: 15217329 BACKGROUND

• Carr J, Shepherd R. Neurological Rehabilitation: Optimizing Motor Performance. Edinburgh: Butterworth Heinemann, 1998.

  BACKGROUND

• Macko RF, Ivey FM, Forrester LW. Task-oriented aerobic exercise in chronic hemiparetic stroke: training protocols and treatment effects. Top Stroke Rehabil. 2005 Winter;12(1):45-57. doi: 10.1310/PJQN-KAN9-TTVY-HYQH.

  PMID: 15736000 BACKGROUND

• Richards CL, Malouin F, Bravo G, Dumas F, Wood-Dauphinee S. The role of technology in task-oriented training in persons with subacute stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2004 Dec;18(4):199-211. doi: 10.1177/1545968304269397.

  PMID: 15537991 BACKGROUND

• Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.

  PMID: 15947263 BACKGROUND

• Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.

  PMID: 19556526 BACKGROUND

• Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790.

  PMID: 21612471 BACKGROUND

• Hidler JM, Wall AE. Alterations in muscle activation patterns during robotic-assisted walking. Clin Biomech (Bristol). 2005 Feb;20(2):184-93. doi: 10.1016/j.clinbiomech.2004.09.016.

  PMID: 15621324 BACKGROUND

• Hidler J, Neckel N. Inverse-dynamics based assessment of gait using a robotic orthosis. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:185-8. doi: 10.1109/IEMBS.2006.259392.

  PMID: 17946800 BACKGROUND

• Mehrholz J, Elsner B, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2013 Jul 25;2013(7):CD006185. doi: 10.1002/14651858.CD006185.pub3.

  PMID: 23888479 BACKGROUND

• Babiloni C, Infarinato F, Marzano N, Iacoboni M, Dassu F, Soricelli A, Rossini PM, Limatola C, Del Percio C. Intra-hemispheric functional coupling of alpha rhythms is related to golfer's performance: a coherence EEG study. Int J Psychophysiol. 2011 Dec;82(3):260-8. doi: 10.1016/j.ijpsycho.2011.09.008. Epub 2011 Sep 22.

  PMID: 21945478 BACKGROUND

• Del Percio C, Babiloni C, Marzano N, Iacoboni M, Infarinato F, Vecchio F, Lizio R, Aschieri P, Fiore A, Toran G, Gallamini M, Baratto M, Eusebi F. "Neural efficiency" of athletes' brain for upright standing: a high-resolution EEG study. Brain Res Bull. 2009 May 29;79(3-4):193-200. doi: 10.1016/j.brainresbull.2009.02.001. Epub 2009 Feb 11.

  PMID: 19429191 BACKGROUND

• Klimesch W. EEG alpha and theta oscillations reflect cognitive and memory performance: a review and analysis. Brain Res Brain Res Rev. 1999 Apr;29(2-3):169-95. doi: 10.1016/s0165-0173(98)00056-3.

  PMID: 10209231 BACKGROUND

• Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006 May;54(5):743-9. doi: 10.1111/j.1532-5415.2006.00701.x.

  PMID: 16696738 BACKGROUND

• Goffredo M, Infarinato F, Pournajaf S, Romano P, Ottaviani M, Pellicciari L, Galafate D, Gabbani D, Gison A, Franceschini M. Barriers to sEMG Assessment During Overground Robot-Assisted Gait Training in Subacute Stroke Patients. Front Neurol. 2020 Oct 19;11:564067. doi: 10.3389/fneur.2020.564067. eCollection 2020.

  PMID: 33193001 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Franceschini, MD

  IRCSSSRaffaele

  STUDY DIRECTOR

• Michela Goffredo, Phd

  IRCSSSRaffaele

  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: SPONSOR

Model Details: Single blind

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 10, 2018
• Study Start: March 16, 2016
• Primary Completion: November 1, 2018
• Study Completion: March 30, 2020
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Actual
• Access Criteria: Open Access

Locations

IT (4)