Multiple SclerosisCLAPENDASNCT05778474
Mechanical Determinants of Upper Limbs Oscillation During Gait
An observational study of Multiple Sclerosis and Poststroke/CVA Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Poststroke/CVA Hemiparesis, Parkinson Disease
- What is being tested?
- Healthy subjects and Pathologic group
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 27 May 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Multiple Sclerosis, Poststroke/CVA Hemiparesis, Parkinson Disease, Cerebral Palsy, Amputation
- Being tested
- Healthy subjects, Pathologic group
- Keywords
- Walking, Upper limb oscillations, Treadmill, Center of Mass, Rehabilitation
- Medical subject headings
- Multiple Sclerosis, Parkinson Disease, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy subjectsOther
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:
- 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.
- Walking. Participants will walk at 0.4 m s-1 and 1.2 m s-1 for at least 30 seconds.
- 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.
Pathologic groupOther
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:
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pathologic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
Spatio parameter
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].
Measured: Day 1
Shoulder and elbow joint angles on the sagittal plane
Shoulder flexion-extension angle, Elbow flexion-extension angle. Angle is measured in degrees (deg.)
Measured: Day 1
Energy of the center of mass
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start27 May 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Tesio, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778474
- Sponsor's protocol ID
- 24C901_2019
- Acronym
- CLAPENDAS
- Status last verified
- Nov 2025
- First submitted
- 27 Feb 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40697531
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Determinants of Upper Limbs Oscillation During Gait
- ClinicalTrials.gov ID
- NCT05778474
- Acronym / sponsor ID
- CLAPENDAS / 24C901_2019
- Conditions
- Multiple Sclerosis, Poststroke/CVA Hemiparesis, Parkinson Disease, Cerebral Palsy, Amputation
- Keywords
- Walking, Upper limb oscillations, Treadmill, Center of Mass, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Other: Healthy subjectsAt 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. |
| Pathologic group | – | Other: Pathologic groupAt 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy subjectsParticipants' 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. | Other | Healthy participants |
| Pathologic groupParticipants 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. | Other | Pathologic group |
Primary outcome
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.
3 secondary outcomes
Spatio parameter
Time frame: Day 1
Shoulder and elbow joint angles on the sagittal plane
Time frame: Day 1
Energy of the center of mass
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 40697531Rota 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Tesio, MD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Poststroke/CVA Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle joint power (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.