Gait Recovery in Patients After Acute Ischemic Stroke

Official title

GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.

Overview

More than 80% of ischemic stroke (IS) patients have some walking disability, which restricts their independence in the activities of daily living. Physical therapy (PT) significantly contributes to gait recovery in patients after IS. However, it remains unclear, what type of gait training is more effective and which factors may have impact on gait recovery. Two hundred fifty IS patients will be enrolled to undergo a 2-week intensive inpatient rehabilitation including randomly assigned robot-assisted treadmill gait training (RTGT) or therapist-assisted treadmill gait training (TTGT). A detailed clinical and laboratory assessment of gait quality, as well as the degree of neurological impairment, quality of life, cognition and depression will be performed in all patients during the study. We hypothesize that these variables may also affect gait recovery in patients after IS. In a randomly selected 60 enrolled patients, a multi-modal magnetic resonance imaging (MRI), including functional MRI, will be performed to assess neural correlates and additional predictors of gait recovery.

Detailed description

One hundred twenty consecutive first ever ischemic stroke patients classified as dependent walkers (Functional Ambulatory Category interval \<1,3\>) will be enrolled in the randomized blinded single center prospective clinical trial GAITFAST with a randomization either for robot-assisted treadmill gait training (RGT) or therapist-assisted treadmill gait training (TTGT) after acute phase (5-10 days after stroke onset). All enrolled patients will undergo a 2-week intensive inpatient rehabilitation including randomly assigned TTGT or RTGT followed with clinical visits (at the beginning of inpatient rehabilitation, at discharge, and three and six months after enrollment in the study). Each clinical visit will include detailed clinical functional assessments, assessment of spatiotemporal and kinetic gait parameters, assessment of neurological impairment, assessment of quality of life, cognition and depression. In 60 randomly selected enrolled IS patients, a repeated multi-modal magnetic resonance imaging (MRI) including functional MRI (fMRI) will be performed during the study follow-up to identify brain structures with possible impact on gait recovery.

Interventions

• Other Robot-assisted treadmill gait training (RTGT)
  Locomotor training guided by the robotic device (Lokomat Hocoma) according to a pre-programmed gait pattern with the help of robot-driven exoskeleton orthoses. The process of gait training is automated and controlled by a computer under supervision of a physiotherapist.
• Other Therapist-assisted treadmill gait training (TTGT)
  Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.

Primary outcome measures

• Change in gait speed during overground walking [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]

Secondary outcome measures (12)

• Change in National Institute of Health Stroke Scale (NIHSS) [Time frame: Enrollment, baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in gait speed (km/h) during patients´ comfort speed [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in gait cadence (steps/min) during patients´ comfort speed [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in paretic and non-paretic leg step length (cm) during patients´ comfort speed [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in duration of stance phase as percentage of gait cycle (%) for paretic and non-paretic limb during patients´ comfort speed [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in double stance phase as percentage of gait cycle (%) during patients´ comfort speed [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in ground reaction force (N) for paretic and non-paretic limb during patients' comfort speed [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in plantar pressure distribution (N/cm2) for paretic and non-paretic limb during patients´ comfort speed [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in Functional Ambulatory Category FAC [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in Fugl-Meyer Assessment [Time frame: baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in functional magnetic resonance imaging activation magnitude [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]
• Change in functional magnetic resonance imaging activation volume [Time frame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)]

Eligibility criteria

Inclusion criteria

• Ischemic stroke detected on magnetic resonance imaging (MRI) with NIHSS score 1-12 points at the time of enrolment
• Lower limb movement impairment with a score of at least 1 point on the NIH Stroke Scale (NIHSS) at the time of enrolment
• Dependency in walking according to Functional Ambulatory Category (FAC) with score interval <1,3> (supervision or assistance, or both, must be given in performing walking)

Exclusion criteria

• Previous history of any stroke, either ischemic or hemorrhagic
• Other diseases modifying or limiting walking ability, currently receiving rehabilitation or participation in another study
• Significant/symptomatic ischemic heart disease or significant/symptomatic peripheral arterial disease
• Obesity (BMI ≥ 40), or weight higher than 110 kg (weight limit for the robot-assisted gait training)
• Sensory aphasia with the inability to understand having been verified by a certified speech therapist.
• Moderate or severe depression present at the time of enrolment assessed using the Beck scale, with a score above 10.
• Known cognitive impairment
• Previous disability or dependence in the daily activities assessed using the modified Rankin Scale with a score of 3 and more points
• Currently receiving dialysis
• Diagnosed and/or receiving treatment for cancer
• Presence of other orthopedic or neurological conditions affecting the lower extremities
• For fMRI: Pregnancy; electronic implants, including cochlear implant, pacemaker, neurostimulator; incompatible metallic implants, including aneurysm clip; metallic intraocular foreign body; large tattoos; unremovable piercing; body weight over 150 kg; known claustrophobia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Czechia · 1 center

• University Hospital Olomouc — Olomouc

Publications

• Norrving B, Kissela B. The global burden of stroke and need for a continuum of care. Neurology. 2013 Jan 15;80(3 Suppl 2):S5-12. doi: 10.1212/WNL.0b013e3182762397. PMID 23319486
• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ PMID 24352519
• Gordon NF, Gulanick M, Costa F, Fletcher G, Franklin BA, Roth EJ, Shephard T; American Heart Association Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Physical activity and exercise recommendations for stroke survivors: an A PMID 15117863
• Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39. PMID 17996052
• Alia C, Spalletti C, Lai S, Panarese A, Lamola G, Bertolucci F, Vallone F, Di Garbo A, Chisari C, Micera S, Caleo M. Neuroplastic Changes Following Brain Ischemia and their Contribution to Stroke Recovery: Novel Approaches in Neurorehabilitation. Front Cell Neurosci. 2017 Mar 16;11:76. doi: 10.3389/fncel.2017.00076. eCollection 2017. PMID 28360842
• Nudo RJ. Recovery after brain injury: mechanisms and principles. Front Hum Neurosci. 2013 Dec 24;7:887. doi: 10.3389/fnhum.2013.00887. PMID 24399951
• Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of functional recovery after stroke: facts and theories. Restor Neurol Neurosci. 2004;22(3-5):281-99. PMID 15502272
• Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2. PMID 25387001

Identifiers

NCT: NCT04824482 · NU21-04-00375

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗