- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05778474
Mechanical Determinants of Upper Limbs Oscillation During Gait (CLAPENDAS)
It is unclear why humans typically swing their arms during gait. To date, the debate on how to arm swing comes about (i.e. whether it is caused by accelerations of the shoulder girdle or muscular activity) is still going on. There needs to be consensus on whether the arm swing is actively controlled or merely passive and on why humans swing their arms during walking (i.e. what the purpose of arm swing is, if any). Suggested reasons include minimising energy consumption, optimising stability, and optimising neural control. Pathologies such as hemiplegia after stroke, Parkinson's disease, Cerebral Palsy, Spinal Cord Injury, and Multiple Sclerosis may directly affect arm swing during gait. Emerging evidence indicates that including arm movements in gait rehabilitation may be beneficial in restoring interlimb coordination and decreasing energy expenditure.
This project hypothesises that the arms swing, at least at low and intermediate walking speeds, reflects the body's Center of Mass (CoM) accelerations. Arm swing may thus depend mainly upon the system's intrinsic mechanical properties (e.g., gravity and inertia). In this perspective, the CoM is seen as moving relative to the upper limbs rather than the other way around. The contribution of major lower limb joints, in terms of power injected into the body motion, will be simultaneously explored.
The study aims to investigate the mechanism and functions of arm swinging during walking on a force treadmill. To simulate asymmetric walking, healthy subjects will be asked to walk with a toes-up orthosis to induce claudication and asymmetry in ankle power. In this way, it will be possible to highlight the correlation among arm swinging, ankle power, and the acceleration of the CoM in a 3D framework. In addition, subjects affected by unilateral motor impairments will be asked to walk on the force treadmill to test the experimental model and highlight significant differences in the kinematic parameters of the upper limbs.
The question of whether arm swing is actively controlled or merely passive and the relationship between arm swinging and the total mechanical energy of the CoM will be faced.
Asymmetric oscillations of the upper limb will be related to dynamic asymmetries of the COM motion, and of the motion of lower limbs. In addition, cause-effect relationships will be hypothesized. Finally, the dynamic correlates of upper limb oscillations will make the clinical observation an interpretable clinical sign applicable to rehabilitation medicine.
Results from the present study will also foster the identification of practical rehabilitation exercises on gait asymmetries in many human nervous diseases.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Milan, Italy, 20145
- Istituto Auxologico Italiano
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- presence of claudication (spatiotemporal asymmetry between subsequent steps), at visual inspection;
- unilateral motor impairments of one lower limb as a consequence of various pathologic conditions, such as (not not limited to): poststroke hemiparesis (ischemic or hemorrhagic), Parkinson's disease, multiple sclerosis, unilateral amputation with prosthetic correction, surgical orthopedic interventions;
- ability to walk for at least 100 meters without support; prostheses or orthoses admitted.
- ability to wittingly sign the informed consent form
Exclusion Criteria:
- drug therapy underway up to three months before recruitment, with impact on balance and gait;
- systemic pathologies or other sensory or neurological pathologies with impact on balance and gait;
- Mini Mental State (MMSE) score < 24/30;
- alterations in the passive mobility of upper limbs;
- painful syndrome which could alter the locomotion;
- pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy participants
At least 10 healthy participants aged from 18 to 60 years old with symmetric walking at visual analysis.
Participants will be excluded if pregnant, if they present with pharmacologic therapies which could affect balance and walking, and if they suffered from (or presently present with) orthopedic or neurologic conditions potentially impairing walking.
|
Participants' ground spontaneous speed overground will be tested by means of the 10-meter walking test. Participants will be tested for their foot dominance by means of the Waterloo footedness questionnaire-revised. Participants will walk on a treadmill mounted on force sensors. The test sequence will be the following:
Participants will repeat the last point (n°3) with the ankle-foot orthosis on the non-dominant lower limb. A 3-min pause will follow each section. |
|
Pathologic group
At least 15 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.
Participants will present a unilateral motor impairment, not preventing passive oscillation of the upper limbs.
|
Participants will walk on a treadmill mounted on force sensors. They will walk freely, under tight supervision, but without hanging to any support. The test sequence will be the following: 4. Familiarization. Participants will walk on the treadmill with the belt running at increasing velocities up to their spontaneous walking velocity . Speed will be increased of 0.1 m s-1 every 30 s. A brief pause of around 1 minute will follow. 5. Walking. Participants will walk at 0.4 m s-1 for at least 30 seconds. Participants will be informed a few seconds before the changes in belts' velocities with a verbal warning. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ankle joint power
Time Frame: Day 1
|
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.
The sagittal plane will be only 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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spatio parameter
Time Frame: Day 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 Step length is measured in meters [m]. |
Day 1
|
|
Shoulder and elbow joint angles on the sagittal plane
Time Frame: Day 1
|
Shoulder flexion-extension angle, Elbow flexion-extension angle.
Angle is measured in degrees (deg.)
|
Day 1
|
|
Energy of the center of mass
Time Frame: Day 1
|
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).
Amounts of energy are measured in Joule/Kg.
|
Day 1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time parameters
Time Frame: Day 1
|
Single Stance Time: for each lower limb, the time interval during which the limb determines vertical ground reactions equal to or exceeding 30 N. Double Stance Time: the time interval during which, under both lower limbs, vertical ground reactions equal or exceed 30 N. Time parameters are measured in seconds [s]. |
Day 1
|
|
The trajectory of the center of mass
Time Frame: Day 1
|
the trajectory of the centre of mass will be studied in the sagittal and frontal planes during the strides.
will be measured in meters [m].
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luigi Tesio, MD, Istituto Auxologico Italiano
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Brain Damage, Chronic
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Multiple Sclerosis
- Cerebral Palsy
- Parkinson Disease
Other Study ID Numbers
- 24C901_2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
Cabaletta BioNot yet recruitingProgressive Multiple Sclerosis | Multiple Sclerosis | Multiple Sclerosis (Relapsing Remitting) | Relapsing Multiple Sclerosis (RMS) | Progressive Multiple Sclerosis (PMS) | Multiple Sclerosis (MS) - Relapsing-remitting | Multiple Sclerosis - Relapsing Remitting
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsActive, not recruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple Sclerosis | Active Secondary Progressive Multiple SclerosisJapan
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on Healthy subjects
-
Centre Hospitalier Universitaire Saint PierreUnknownDynamic HyperinflationBelgium
-
Nigde Omer Halisdemir UniversityActive, not recruiting
-
Nadia Bouzidi, PhDUnknown
-
Hospices Civils de LyonCompleted
-
Buddhist Tzu Chi General HospitalCompletedIrritable Bowel Syndrome | Functional Gastrointestinal Disorders | Healthy Subjects | Laryngopharyngeal RefluxTaiwan
-
Oregon Health and Science UniversityCompleted
-
Massachusetts General HospitalMassachusetts Eye and Ear InfirmaryCompleted
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
International Agency for Research on CancerFederico II University; Imperial College London; Fondazione IRCCS Istituto Nazionale... and other collaboratorsCompleted
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedAttention Deficit Disorder With HyperactivityBrazil