Ischemic StrokeGAITFASTNCT04824482
Gait Recovery in Patients After Acute Ischemic Stroke
A study testing Robot-assisted treadmill gait training (RTGT) and Therapist-assisted treadmill gait training (TTGT) in people with Ischemic Stroke, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Robot-assisted treadmill gait training (RTGT) and Therapist-assisted treadmill gait training (TTGT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Olomouc
Olomouc, 77520
Petr Kolar, MD, PhD, +420588445197, petr.kolar@fnol.cz
Daniel Sanak, MD, PhD, +420588442836, daniel.sanak@fnol.cz
About this study
Official title: GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Robot-assisted treadmill gait training (RTGT), Therapist-assisted treadmill gait training (TTGT)
- Keywords
- Ischemic Stroke, Stroke rehabilitation, Physical Therapy, Gait, Exoskeleton Device, Walking speed, Gait Analysis, Functional Magnetic Resonance Imaging
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted treadmill gait training (RTGT)Other
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.
Therapist-assisted treadmill gait training (TTGT)Other
Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted treadmill gait training (RTGT) | Experimental | 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. Receives: Other: Robot-assisted treadmill gait training (RTGT) |
| Therapist-assisted treadmill gait training (TTGT) | Active comparator | Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training. Receives: Other: Therapist-assisted treadmill gait training (TTGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed during overground walking
Gait speed will be measured using the 10 Meters Walking Test (performance measure used to assess walking speed in meters per second over a short distance). The subject will be asked to walk for a distance of 10 meters at his/her comfortable speed. The time will be measured for the distance of the middle six meters, which will allow walk acceleration and deceleration. Each patient will perform two trials with a calculation of mean time value. If physical assistance of another person (to prevent a fall or collapsing) is needed for a patient to complete the test, the level of assistance provided will be documented. Usage of any assistive device and/or bracing (that patients are currently using for walking and are needed to complete the test) will be also documented.
Measured: 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 outcomes (12)
Change in National Institute of Health Stroke Scale (NIHSS)
NIHSS is used to objectively quantify the impairment caused by a stroke.
Measured: 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
Gait speed will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Measured: 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
Gait cadence will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Measured: 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
Change in paretic and non-paretic leg step length will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Measured: 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
Change in duration of stance phase will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Measured: 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
Change in double stance phase will be assessed by treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Measured: 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
Change in ground reaction force will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Measured: 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
Change in plantar pressure distribution will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Measured: 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
Functional walking test that assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required.
Measured: 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
Fugl-Meyer Assessment uses to examine the sensory-motor function and coordination of affected lower extremity.
Measured: 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
Functional MRI activation magnitude, calculated as difference in BOLD signal between task and rest, will be assessed within pre-defined gait-related brain regions of interest (ROIs), i.e., sensorimotor cortex, premotor cortex, supplementary motor area, brainstem and cerebellum. Change in these ROI parameters over time will be statistically tested within group and the regional post-training minus pre-training difference in each group will be submitted to between-group analysis.
Measured: 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
Functional MRI activation volume, summed over significantly activated voxels, will be assessed within pre-defined gait-related brain regions of interest (ROIs), i.e., sensorimotor cortex, premotor cortex, supplementary motor area, brainstem and cerebellum. Change in these ROI parameters over time will be statistically tested within group and the regional post-training minus pre-training difference in each group will be submitted to between-group analysis.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Sep 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will be randomly assigned to two parallel intervention groups for the duration of study. Thirty patients from each intervention group will be randomized to multimodal MRI of brain.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University
- Responsible party
- Principal investigator, Barbora Kolarova, University Hospital Olomouc
- Investigators
- Petr Hlustik, MD, PhD, Study chair, Palacky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824482
- Sponsor's protocol ID
- NU21-04-00375
- Acronym
- GAITFAST
- Status last verified
- Jul 2022
- First submitted
- 24 Mar 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 23319486Go 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, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
PubMed 24352519Gordon 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 American Heart Association scientific statement from the 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. Circulation. 2004 Apr 27;109(16):2031-41. doi: 10.1161/01.CIR.0000126280.65777.A4. No abstract available.
PubMed 15117863Duncan 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.
PubMed 17996052Alia 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.
PubMed 28360842Nudo RJ. Recovery after brain injury: mechanisms and principles. Front Hum Neurosci. 2013 Dec 24;7:887. doi: 10.3389/fnhum.2013.00887.
PubMed 24399951Kwakkel 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.
PubMed 15502272Pollock 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.
PubMed 25387001Kerr AL, Cheng SY, Jones TA. Experience-dependent neural plasticity in the adult damaged brain. J Commun Disord. 2011 Sep-Oct;44(5):538-48. doi: 10.1016/j.jcomdis.2011.04.011. Epub 2011 May 6.
PubMed 21620413Kleim JA, Barbay S, Nudo RJ. Functional reorganization of the rat motor cortex following motor skill learning. J Neurophysiol. 1998 Dec;80(6):3321-5. doi: 10.1152/jn.1998.80.6.3321.
PubMed 9862925Wallard L, Dietrich G, Kerlirzin Y, Bredin J. Effects of robotic gait rehabilitation on biomechanical parameters in the chronic hemiplegic patients. Neurophysiol Clin. 2015 Sep;45(3):215-9. doi: 10.1016/j.neucli.2015.03.002. Epub 2015 Sep 14.
PubMed 26381192Luft AR, Macko RF, Forrester LW, Villagra F, Ivey F, Sorkin JD, Whitall J, McCombe-Waller S, Katzel L, Goldberg AP, Hanley DF. Treadmill exercise activates subcortical neural networks and improves walking after stroke: a randomized controlled trial. Stroke. 2008 Dec;39(12):3341-50. doi: 10.1161/STROKEAHA.108.527531. Epub 2008 Aug 28.
PubMed 18757284Enzinger C, Dawes H, Johansen-Berg H, Wade D, Bogdanovic M, Collett J, Guy C, Kischka U, Ropele S, Fazekas F, Matthews PM. Brain activity changes associated with treadmill training after stroke. Stroke. 2009 Jul;40(7):2460-7. doi: 10.1161/STROKEAHA.109.550053. Epub 2009 May 21.
PubMed 19461018Burke E, Dobkin BH, Noser EA, Enney LA, Cramer SC. Predictors and biomarkers of treatment gains in a clinical stroke trial targeting the lower extremity. Stroke. 2014 Aug;45(8):2379-84. doi: 10.1161/STROKEAHA.114.005436. Epub 2014 Jun 24.
PubMed 25070961Jahn K, Deutschlander A, Stephan T, Strupp M, Wiesmann M, Brandt T. Brain activation patterns during imagined stance and locomotion in functional magnetic resonance imaging. Neuroimage. 2004 Aug;22(4):1722-31. doi: 10.1016/j.neuroimage.2004.05.017.
PubMed 15275928
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.
- ClinicalTrials.gov ID
- NCT04824482
- Acronym / sponsor ID
- GAITFAST / NU21-04-00375
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Stroke rehabilitation, Physical Therapy, Gait, Exoskeleton Device, Walking speed, Gait Analysis, Functional Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Palacky University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will be randomly assigned to two parallel intervention groups for the duration of study. Thirty patients from each intervention group will be randomized to multimodal MRI of brain.
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted treadmill gait training (RTGT) | Experimental | 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. |
| Therapist-assisted treadmill gait training (TTGT) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Robot-assisted treadmill gait training (RTGT) |
| Therapist-assisted treadmill gait training (TTGT)Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training. | Other | Therapist-assisted treadmill gait training (TTGT) |
Primary outcome
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)
Gait speed will be measured using the 10 Meters Walking Test (performance measure used to assess walking speed in meters per second over a short distance). The subject will be asked to walk for a distance of 10 meters at his/her comfortable speed. The time will be measured for the distance of the middle six meters, which will allow walk acceleration and deceleration. Each patient will perform two trials with a calculation of mean time value. If physical assistance of another person (to prevent a fall or collapsing) is needed for a patient to complete the test, the level of assistance provided will be documented. Usage of any assistive device and/or bracing (that patients are currently using for walking and are needed to complete the test) will be also documented.
12 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Background: PubMed 23319486Norrving 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.
- Background: PubMed 24352519Go 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, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
- Background: PubMed 15117863Gordon 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 American Heart Association scientific statement from the 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. Circulation. 2004 Apr 27;109(16):2031-41. doi: 10.1161/01.CIR.0000126280.65777.A4. No abstract available.
- Background: PubMed 17996052Duncan 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.
- Background: PubMed 28360842Alia 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.
- Background: PubMed 24399951Nudo RJ. Recovery after brain injury: mechanisms and principles. Front Hum Neurosci. 2013 Dec 24;7:887. doi: 10.3389/fnhum.2013.00887.
- Background: PubMed 15502272Kwakkel 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.
- Background: PubMed 25387001Pollock 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.
- Background: PubMed 21620413Kerr AL, Cheng SY, Jones TA. Experience-dependent neural plasticity in the adult damaged brain. J Commun Disord. 2011 Sep-Oct;44(5):538-48. doi: 10.1016/j.jcomdis.2011.04.011. Epub 2011 May 6.
- Background: PubMed 9862925Kleim JA, Barbay S, Nudo RJ. Functional reorganization of the rat motor cortex following motor skill learning. J Neurophysiol. 1998 Dec;80(6):3321-5. doi: 10.1152/jn.1998.80.6.3321.
- Background: PubMed 26381192Wallard L, Dietrich G, Kerlirzin Y, Bredin J. Effects of robotic gait rehabilitation on biomechanical parameters in the chronic hemiplegic patients. Neurophysiol Clin. 2015 Sep;45(3):215-9. doi: 10.1016/j.neucli.2015.03.002. Epub 2015 Sep 14.
- Background: PubMed 18757284Luft AR, Macko RF, Forrester LW, Villagra F, Ivey F, Sorkin JD, Whitall J, McCombe-Waller S, Katzel L, Goldberg AP, Hanley DF. Treadmill exercise activates subcortical neural networks and improves walking after stroke: a randomized controlled trial. Stroke. 2008 Dec;39(12):3341-50. doi: 10.1161/STROKEAHA.108.527531. Epub 2008 Aug 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petr Hlustik, MD, PhD study chair
Palacky University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted treadmill gait training (RTGT) and Therapist-assisted treadmill gait training (TTGT) in people with Ischemic Stroke, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbora Kolarova, PhD (+420 588 442 301, barbora.kolarova@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04824482, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.