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Multiple SclerosisESPLICANCT04635436

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

A study testing Split-belt treadmill walking. in people with Multiple Sclerosis and Poststroke/CVA Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Split-belt treadmill walking.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteItaly
Study dates
5 Feb 2020to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Istituto Auxologico Italiano

    Milan, MI, 20121

Other trials in Italy

About this study

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.

Read more

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.

Being tested
Split-belt treadmill walking.
Keywords
walking, split-belt treadmill, motor adaptation, after-effect, dynamic symmetry, rehabilitation
Medical subject headings
Multiple Sclerosis, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04635436
Study groupRoleWhat they receive
Pathologic groupOtherAt 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.
Receives: Other: Split-belt treadmill walking.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Two assessments, at one week-interval

Secondary outcomes (4)
  1. Step Length

    The sagittal distance between the markers put on the lateral malleolus of the posterior and anterior feet at the ground strike of the anterior foot. The side of step will be defined as the side of the posterior foot during double stance .

    Measured: Two assessments, at one week-interval

  2. Single Stance Time

    For each lower limb, the time interval during which the limb determines vertical ground reactions equal to or exceeding 30 N.

    Measured: Two assessments, at one week-interval

  3. Double Stance Time

    The time interval during which, under both lower limbs, vertical ground reactions equal or exceed 30 N. The side of the double stance time will be defined as the side of the posterior foot.

    Measured: Two assessments, at one week-interval

  4. Parameters of the center of mass motion

    The changes in kinetic energy due to the forward (Ekf), lateral (Ekl) and vertical (Ekv) velocity; the changes of gravitational potential energy (Ep); the changes of the mechanical energy due to the vertical motion, Ev = Ekv+Ep; the changes of the total mechanical energy (Etot = Ekf+Ekl +Ev). The amount of recovery of mechanical energy, R, due to the passive exchange between Ekf, Ev and Ekl, will be calculated according to the equation R = (Wf + Wv + Wl - Wext)/(Wf + Wv + Wl) × 100, where Wf for Ekf, Wv for Ev, Wl for Ekl and Wtot for Etot represents the corresponding work values calculated as the sum of the positive increments of these energy values during one step.

    Measured: Two assessments, at one week-interval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study start5 Feb 2020
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04635436
Sponsor's protocol ID
24C902_2019
Acronym
ESPLICA
Status last verified
May 2025
First submitted
13 Nov 2020
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 28086163
  • 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.

    PubMed 28901824
  • 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.

    PubMed 26522907
  • 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.

    PubMed 25074249
  • 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.

    PubMed 24243917
  • 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.

    PubMed 22514294
  • 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.

    PubMed 20023001
  • 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.

    PubMed 15958603
  • 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.

    PubMed 23392918
  • 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.

    PubMed 17405765
  • 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.

    PubMed 19307434
  • 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.

    PubMed 28596214
  • 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.

    PubMed 28126335
  • 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.

    PubMed 30303831
  • 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.

    PubMed 18388556

Questions about this trial

What is this clinical trial studying?

A study testing Split-belt treadmill walking. in people with Multiple Sclerosis and Poststroke/CVA Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.

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 6 inclusion and 5 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: finished, as of the sponsor's last update on 4 Nov 2026. 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ankle Joint Power (time frame: Two assessments, at one week-interval). 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 NCT04635436, which also lists 15 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 4 Nov 2026.

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