Efficacy of Split Gait in the Treatment of Dynamic Asymmetries in Subjects With Pathologic Claudication

NCT04635436 | Recruiting

• 1 other identifier: 24C902_2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Poststroke/CVA Hemiparesis; Parkinson Disease; Amputation; Knee Impairment

Keywords

walking; split-belt treadmill; motor adaptation; after-effect; dynamic symmetry; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Ankle Joint Power

  Joint kinematics will be recorded through an optoelectronic method as per the Davis anthropometric model. The 3D displacement of the markers will be captured using 10 near-infrared stroboscopic cameras. Joint power will be computed through the spatiotemporal synchronization of ground reaction force vectors and the joint centers of rotation. Only the sagittal plane will be considered for the analysis. Joint power will be computed as the product of joint torque and joint rotation speed. Power will be defined as positive or generated when the joint moment and rotation speed shared the same directions (i. e., when agonist muscles are contracting while shortening), as negative or absorbed otherwise. Positive work will be computed as the integral of the generated (positive) power over time.

  Two assessments, at one week-interval

Secondary Outcomes (4)

• Step Length

  Two assessments, at one week-interval

• Single Stance Time

  Two assessments, at one week-interval

• Double Stance Time

  Two assessments, at one week-interval

• Parameters of the center of mass motion

  Two assessments, at one week-interval

Study Arms (1)

Pathologic group

OTHER

At least 20 participants with various orthopaedic or neurologic conditions (for example, post-stroke hemiparesis, Parkinson's disease, multiple sclerosis, unilateral amputation, surgical orthopedic interventions) will be enrolled.

Other: Split-belt treadmill walking.

Interventions

Split-belt treadmill walking. OTHER

The intervention will consist of split-belt treadmill walking. During the test session, participants will walk on a split-belt treadmill mounted on force sensors with the belts running at the same or at different velocities. They will walk freely without any support. The test sequence will be the following: 1. Baseline phase. 3 minutes walking at increasing speed, speed will be increased of 0.1 m s-1 every 30 s. A brief pause of around 1 minute will follow. 2. Habituation phase. 30 seconds walking at 0.2 m s-1. 3. Adaptation phase. The velocity of the belt under the non-affected lower limb will be increased to 0.6 m s-1, while the other belt will maintain its velocity of 0.2 m s-1 for 6 minutes. 4. Post-adaptation phase. Belts' velocities will be restored at 0.2 m s-1 for 6 minutes. Participants will be informed before the changes in belts' velocities with a verbal warning. Participants will repeat the same protocol with the affected lower limb on the fast belt after one week.

Pathologic group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• systemic neurologic pathologies;
• symptomatic pathologies of rachis;
• other sensory or neurological pathologies with impact on balance and gait;
• pregnancy.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, MI, 20121, Italy

RECRUITING

Related Publications (15)

• 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.

  PMID: 28086163 BACKGROUND

• 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.

  PMID: 28901824 BACKGROUND

• 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.

  PMID: 26522907 BACKGROUND

• 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.

  PMID: 25074249 BACKGROUND

• 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.

  PMID: 24243917 BACKGROUND

• 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.

  PMID: 22514294 BACKGROUND

• 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.

  PMID: 20023001 BACKGROUND

• 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.

  PMID: 15958603 BACKGROUND

• 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.

  PMID: 23392918 BACKGROUND

• 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.

  PMID: 17405765 BACKGROUND

• 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.

  PMID: 19307434 BACKGROUND

• 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.

  PMID: 28596214 BACKGROUND

• 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.

  PMID: 28126335 BACKGROUND

• 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.

  PMID: 30303831 BACKGROUND

• 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.

  PMID: 18388556 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Parkinson Disease

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Luigi Tesio, MD, Full professor

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Tesio, MD, Full Professor

CONTACT

+39 02 58218151; l.tesio@auxologico.it

Stefano Scarano, MD, Research Fellow

CONTACT

+39 02 58218717; s.scarano@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director of the Department of Neuromotor Rehabilitation, Ospedale San Luca, Istituto Auxologico Italiano, IRCCS; Full Professor, Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: February 5, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)