Clinical trial NCT04635436: Efficacy of Split Gait in the Treatment of Dynamic Asymmetries in Subjects With Pathologic Claudication
Official title: Efficacy of Split Gait in the Treatment of Dynamic Asymmetries in Subjects With Pathologic Claudication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Poststroke/CVA Hemiparesis
Parkinson Disease
Amputation
Knee Impairment
Keywords: walking
split-belt treadmill
motor adaptation
after-effect
dynamic symmetry
rehabilitation
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Walking on a split-belt treadmill (each of the two belts running at a different speed) imposes an asymmetrical gait, mimicking limping that has been observed in various pathologic conditions. This walking modality has been proposed as an experimental paradigm to investigate the flexibility of the neural control of gait and as a form of therapeutic exercise for hemi-paretic patients. However, the scarcity of dynamic investigations both for segmental aspects and for the entire body system, represented by the centre of mass, challenges the validity of the available findings on split gait.

Compared with overground gait in hemiplegia, split gait entails an opposite spatial and dynamic asymmetry. The faster leg mimics the paretic limb temporally, but the unimpaired limb from the spatial and dynamic point of view. These differences suggest that a partial shift in perspective may help to clarify the potential of the split gait as a rehabilitation tool.

The aim of the present study is to investigate the dynamic asymmetries of lower limbs in adults with unilateral motor impairments (e.g. hemiplegia post-stroke, Parkinson's disease, multiple sclerosis, unilateral amputation, surgical orthopedic interventions) during adaptation to gait on a split-belt treadmill. The sagittal power provided by the ankle and the total mechanical energy of the centre of mass will be thoroughly studied. The time course of phenomena both during gait when the belts are running at different speed and when the belts are set back to the same speed (i.e. the after-effect) will be investigated.

A greater dynamic symmetry between the lower limbs is expected after split gait. The question whether this symmetry will occur when the pathological limb is on the faster or the lower belt will be disclosed. Some alterations of the motion of the centre of mass during split gait are also expected.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 70 years old;
* ability to walk for at least 20 meters without support;
* ability to wittingly sign the informed consent form;
* ability to understand the instructions and to complete the motor task;
* visual acuity \> 10/20 on the worse side, with optical correction;
* unilateral motor impairments of one lower limb as a consequence of various pathologic conditions, such as (not exhausting list): post-stroke hemiparesis, Parkinson's disease with lateral asymmetry in the motor symptoms, multiple sclerosis with lateral asymmetry in the motor symptoms, unilateral amputation with prosthetic correction, surgical orthopedic interventions, unilateral lesions of peripheral nerves.

Exclusion Criteria:

* systemic neurologic pathologies;
* orthopedic surgical interventions, other than those determining the inclusion criteria;
* symptomatic pathologies of rachis;
* other sensory or neurological pathologies with impact on balance and gait;
* pregnancy.

Primary outcomes:
measure: Ankle Joint Power
timeFrame: Two assessments, at one week-interval
Secondary outcomes:
measure: Step Length
timeFrame: Two assessments, at one week-interval
measure: Single Stance Time
timeFrame: Two assessments, at one week-interval
measure: Double Stance Time
timeFrame: Two assessments, at one week-interval
measure: Parameters of the center of mass motion
timeFrame: Two assessments, at one week-interval
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
state: MI
Study officials:
affiliation: Istituto Auxologico Italiano
name: Luigi Tesio, MD, Full professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Betschart M, Lauziere S, Mieville C, McFadyen BJ, Nadeau S. Changes in lower limb muscle activity after walking on a split-belt treadmill in individuals post-stroke. J Electromyogr Kinesiol. 2017 Feb;32:93-100. doi: 10.1016/j.jelekin.2016.12.007. Epub 2017 Jan 3.
citation: Betschart M, McFadyen BJ, Nadeau S. Repeated split-belt treadmill walking improved gait ability in individuals with chronic stroke: A pilot study. Physiother Theory Pract. 2018 Feb;34(2):81-90. doi: 10.1080/09593985.2017.1375055. Epub 2017 Sep 13.
citation: Helm EE, Reisman DS. The Split-Belt Walking Paradigm: Exploring Motor Learning and Spatiotemporal Asymmetry Poststroke. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):703-13. doi: 10.1016/j.pmr.2015.06.010. Epub 2015 Sep 26.
citation: Lauziere S, Mieville C, Betschart M, Duclos C, Aissaoui R, Nadeau S. Plantarflexion moment is a contributor to step length after-effect following walking on a split-belt treadmill in individuals with stroke and healthy individuals. J Rehabil Med. 2014 Oct;46(9):849-57. doi: 10.2340/16501977-1845.
citation: Malone LA, Bastian AJ. Spatial and temporal asymmetries in gait predict split-belt adaptation behavior in stroke. Neurorehabil Neural Repair. 2014 Mar-Apr;28(3):230-40. doi: 10.1177/1545968313505912. Epub 2013 Nov 15.
citation: Malone LA, Bastian AJ, Torres-Oviedo G. How does the motor system correct for errors in time and space during locomotor adaptation? J Neurophysiol. 2012 Jul;108(2):672-83. doi: 10.1152/jn.00391.2011. Epub 2012 Apr 18.
citation: Reisman DS, Bastian AJ, Morton SM. Neurophysiologic and rehabilitation insights from the split-belt and other locomotor adaptation paradigms. Phys Ther. 2010 Feb;90(2):187-95. doi: 10.2522/ptj.20090073. Epub 2009 Dec 18.
citation: Reisman DS, Block HJ, Bastian AJ. Interlimb coordination during locomotion: what can be adapted and stored? J Neurophysiol. 2005 Oct;94(4):2403-15. doi: 10.1152/jn.00089.2005. Epub 2005 Jun 15.
citation: Reisman DS, McLean H, Keller J, Danks KA, Bastian AJ. Repeated split-belt treadmill training improves poststroke step length asymmetry. Neurorehabil Neural Repair. 2013 Jun;27(5):460-8. doi: 10.1177/1545968312474118. Epub 2013 Feb 7.
citation: Reisman DS, Wityk R, Silver K, Bastian AJ. Locomotor adaptation on a split-belt treadmill can improve walking symmetry post-stroke. Brain. 2007 Jul;130(Pt 7):1861-72. doi: 10.1093/brain/awm035. Epub 2007 Apr 2.
citation: Reisman DS, Wityk R, Silver K, Bastian AJ. Split-belt treadmill adaptation transfers to overground walking in persons poststroke. Neurorehabil Neural Repair. 2009 Sep;23(7):735-44. doi: 10.1177/1545968309332880. Epub 2009 Mar 23.
citation: Selgrade BP, Thajchayapong M, Lee GE, Toney ME, Chang YH. Changes in mechanical work during neural adaptation to asymmetric locomotion. J Exp Biol. 2017 Aug 15;220(Pt 16):2993-3000. doi: 10.1242/jeb.149450. Epub 2017 Jun 8.
citation: Selgrade BP, Toney ME, Chang YH. Two biomechanical strategies for locomotor adaptation to split-belt treadmill walking in subjects with and without transtibial amputation. J Biomech. 2017 Feb 28;53:136-143. doi: 10.1016/j.jbiomech.2017.01.012. Epub 2017 Jan 14.
citation: Tesio L, Malloggi C, Malfitano C, Coccetta CA, Catino L, Rota V. Limping on split-belt treadmills implies opposite kinematic and dynamic lower limb asymmetries. Int J Rehabil Res. 2018 Dec;41(4):304-315. doi: 10.1097/MRR.0000000000000320.
citation: Tesio L, Rota V. Gait analysis on split-belt force treadmills: validation of an instrument. Am J Phys Med Rehabil. 2008 Jul;87(7):515-26. doi: 10.1097/PHM.0b013e31816f17e1.