Cardiovascular Diseases Clinical Trial
— EKSOGAITOfficial title:
Stroke Rehabilitation With Exoskeleton-assisted Gait: Clinical and Neuromuscular Outcomes.
NCT number | NCT03395717 |
Other study ID # | RP 10/15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 16, 2016 |
Est. completion date | March 30, 2020 |
Verified date | April 2024 |
Source | IRCCS San Raffaele Roma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 162 |
Est. completion date | March 30, 2020 |
Est. primary completion date | November 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - stroke or similar neurological pathologies: - 2 weeks up to 6 months after the acute event (subacute patients); - 6 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. Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Italy | Villa Beretta | Costa Masnaga | |
Italy | Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) Trevi | Foligno | |
Italy | IRCCS San Raffaele Pisana | Roma | |
Italy | Fondazione Centri di Riabilitazione Padre Pio Onlus | San Giovanni Rotondo |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele Roma | Fondazione Centri di Riabilitazione Padre Pio Onlus, IRCCS Sacro Cuore Don Calabria di Negrar, Kos Care - Istituto Santo Stefano Ancona, Kos Care - Istituto Santo Stefano Porto Potenza, Ospedale Riabilitativo di Alta Specializzazione Motta Di Livenza -Treviso, Struttura Complessa di Riabilitazione Intensiva Neuromotoria (S.C.R.I.N.) Foligno - Trevi, Villa Beretta Rehabilitation Center |
Italy,
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. — View Citation
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. — View Citation
Carr J, Shepherd R. Neurological Rehabilitation: Optimizing Motor Performance. Edinburgh: Butterworth Heinemann, 1998.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Hidler JM, Wall AE. Alterations in muscle activation patterns during robotic-assisted walking. Clin Biomech (Bristol, Avon). 2005 Feb;20(2):184-93. doi: 10.1016/j.clinbiomech.2004.09.016. — View Citation
Kandel ER., Schwartz JH., Jessel TM. Fondamenti delle neuroscienze e del comportamento. Casa Editrice Ambrosiana. 1°Ed. 1999.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
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. — View Citation
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. — View Citation
Perry J. Analisi del movimento. Elsevier Italia srl, Milano 2005.
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. — View Citation
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. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Numeric Rating SCale (NRS) | for assessing pain, tolerance and sense of security during exoskeleton-assisted gait | Session 1 (baseline), Session 12 (week 4) | |
Other | Change in surface ElectroMyoGraphy (sEMG) | sEMG will be acquired in order to study neuromuscular variations. The electrical potentials of following muscles will be gathered: biceps femoris, quadriceps femoris, tibialis anterior, and gastrocnemius muscle (medial head). The surface electrodes will be placed by following the SENIAM protocol.
The sEMG will be acquired during the following tasks (if the patient is able to do them): upright position for 30 s; 10 meters-long ecological gait; during ankle, knee and hip flexion/extension tasks; robot-assisted gait (if the patient takes part of the EG) In order to identify the gait phases during the tasks 2 and 3, an inertial sensor (IMU) will be placed at L5 level. |
Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20) | |
Primary | 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 | 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), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20) | |
Secondary | Change in Time Up And Go (TUG) | The TUG 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), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20) | |
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), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20) | |
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), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20) | |
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) 1 leg score for each side = SUM (points for the 3 leg tests) + 1 Interpretation: minimum score: 0; maximum score:100 |
Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20) | |
Secondary | Change in Functional Ambulation Classification (FAC) | FAC 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), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20) | |
Secondary | Change in Handicap Walking Scale (WHS) | WHS 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. | Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20) | |
Secondary | Change in Barthel Index (BI | The BI is a measure of Activity of Daily Living (ADL), which shows the degree of independence of a patient from any assistance. | Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20) |
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