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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04635436
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Istituto Auxologico Italiano
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Luigi Tesio, MD, Full professor
Principal Investigator Affiliation	Istituto Auxologico Italiano
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Poststroke/CVA Hemiparesis, Parkinson Disease, Amputation, Knee Impairment

Arms & Interventions

Arms

: 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.

Interventions

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: 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. Habituation phase. 30 seconds walking at 0.2 m s-1. 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. 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.

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International Sites

Istituto Auxologico Italiano, Milan, MI, Italy

Status

Recruiting

Address

Istituto Auxologico Italiano

Milan, MI, 20121

Site Contact

Stefano Scarano, MD, Research Fellow

[email protected]

+39 02 58218717

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