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Mechanical Determinants of Upper Limbs Oscillation During Gait (CLAPENDAS)

Primary Purpose

Multiple Sclerosis, Poststroke/CVA Hemiparesis, Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Healthy subjects
Pathologic group
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Walking, Upper limb oscillations, Treadmill, Center of Mass, Rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Auxologico ItalianoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy participants

Pathologic group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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].
Shoulder and elbow joint angles on the sagittal plane
Shoulder flexion-extension angle, Elbow flexion-extension angle. Angle is measured in degrees (deg.)
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.

Full Information

First Posted
February 27, 2023
Last Updated
March 9, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05778474
Brief Title
Mechanical Determinants of Upper Limbs Oscillation During Gait
Acronym
CLAPENDAS
Official Title
Mechanical Determinants of Upper Limbs Oscillation During Gait
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Poststroke/CVA Hemiparesis, Parkinson Disease, Cerebral Palsy, Amputation
Keywords
Walking, Upper limb oscillations, Treadmill, Center of Mass, Rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy participants
Arm Type
Experimental
Arm Description
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.
Arm Title
Pathologic group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Healthy subjects
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pathologic group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ankle joint power
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Spatio parameter
Description
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].
Time Frame
Day 1
Title
Shoulder and elbow joint angles on the sagittal plane
Description
Shoulder flexion-extension angle, Elbow flexion-extension angle. Angle is measured in degrees (deg.)
Time Frame
Day 1
Title
Energy of the center of mass
Description
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.
Time Frame
Day 1
Other Pre-specified Outcome Measures:
Title
Time parameters
Description
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].
Time Frame
Day 1
Title
The trajectory of the center of mass
Description
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].
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Tesio, MD
Phone
+39 02619116151
Email
l.tesio@auxologico.it
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Scarano, MD,Research Fellow
Phone
+39 02619116717
Email
s.scarano@auxologico.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Tesio, MD
Organizational Affiliation
Istituto Auxologico Italiano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Auxologico Italiano
City
Milan
ZIP/Postal Code
20145
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Scarano, MD, Research Fellow
Phone
+39 02 619116717
Email
s.scarano@auxologico.it
First Name & Middle Initial & Last Name & Degree
Chiara Malloggi, PhD
First Name & Middle Initial & Last Name & Degree
Viviana Rota, PhD
First Name & Middle Initial & Last Name & Degree
Luigi Catino, MSC
First Name & Middle Initial & Last Name & Degree
Laura Perucca, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Mechanical Determinants of Upper Limbs Oscillation During Gait

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