NCT05778474

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

4.6 years

First QC Date

February 27, 2023

Last Update Submit

November 17, 2025

Conditions

Keywords

WalkingUpper limb oscillationsTreadmillCenter of MassRehabilitation

Outcome Measures

Primary Outcomes (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. 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 Outcomes (3)

  • Spatio parameter

    Day 1

  • Shoulder and elbow joint angles on the sagittal plane

    Day 1

  • Energy of the center of mass

    Day 1

Other Outcomes (2)

  • Time parameters

    Day 1

  • The trajectory of the center of mass

    Day 1

Study Arms (2)

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.

Other: Healthy subjects

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.

Other: Pathologic group

Interventions

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: 1. 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 0.2 m s-1 every 30 s. A brief pause of around 1 minute will follow. 2. Walking. Participants will walk at 0.4 m s-1 and 1.2 m s-1 for at least 30 seconds. 3. Walking with a rigid ankle-foot orthosis. Participants will walk at 0.4 m s-1 and 1.2 m s-1 for at least 30 seconds with an ankle-foot orthosis on the dominant lower limb. 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.

Healthy participants

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.

Pathologic group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20145, Italy

Location

Related Publications (1)

  • Rota V, Caronni A, Scarano S, Amadei M, Tesio L. Plantar flexors are the main engine of walking in healthy adults. Front Sports Act Living. 2025 Jul 8;7:1595065. doi: 10.3389/fspor.2025.1595065. eCollection 2025.

MeSH Terms

Conditions

Multiple SclerosisParkinson DiseaseCerebral Palsy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBrain Damage, Chronic

Study Officials

  • Luigi Tesio, MD

    Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 21, 2023

Study Start

May 27, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Locations