NCT04635436 Efficacy of Split Gait in the Treatment of Dynamic Asymmetries in Subjects With Pathologic Claudication
| NCT ID | NCT04635436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-02-05 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2020-02-05 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Luigi Tesio, MD, Full professor
PRINCIPAL INVESTIGATOR
Istituto Auxologico Italiano
Frequently Asked Questions
Who can join the NCT04635436 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04635436 currently recruiting?
Yes, NCT04635436 is actively recruiting participants. Contact the research team at l.tesio@auxologico.it for enrollment information.
Where is the NCT04635436 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT04635436 clinical trial?
NCT04635436 is sponsored by Istituto Auxologico Italiano. The principal investigator is Luigi Tesio, MD, Full professor at Istituto Auxologico Italiano. The trial plans to enroll 20 participants.
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