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

March 8, 2024 updated by: Luigi Tesio, Prof, Istituto Auxologico Italiano

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20121
        • Recruiting
        • Istituto Auxologico Italiano
        • Contact:
        • Sub-Investigator:
          • Chiara Malloggi, PhD
        • Sub-Investigator:
          • Viviana Rota, PhD
        • Sub-Investigator:
          • Stefano Scarano, MD, Research Fellow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The subjects will be recruited in the proposing Operational Unit on an outpatient basis, from a physiatric referral or from an inpatient rehabilitation unit.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pathologic group
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: Pathologic group

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 hanging to any support. The test sequence will be the following:

  1. Baseline phase. 3 minutes walking at increasing speed from 0.2 m s-1 to 0.6 m s-1, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle Joint Power
Time Frame: Two assessments, at one week-interval
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step Length
Time Frame: Two assessments, at one week-interval
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 .
Two assessments, at one week-interval
Single Stance Time
Time Frame: Two assessments, at one week-interval
For each lower limb, the time interval during which the limb determines vertical ground reactions equal to or exceeding 30 N.
Two assessments, at one week-interval
Double Stance Time
Time Frame: Two assessments, at one week-interval
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.
Two assessments, at one week-interval
Parameters of the center of mass motion
Time Frame: Two assessments, at one week-interval
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.
Two assessments, at one week-interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Investigators

  • Principal Investigator: Luigi Tesio, MD, Full professor, Istituto Auxologico Italiano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24C902_2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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