Effects of Nordic Walking and Free Walking on Arm Swing Parameters and Gait in Parkinson's Disease

March 26, 2024 updated by: Jéssica Espinoza Araneda, University of Talca

Effects of a Nordic Walking Program on Arm Swing Asymmetry and Temporospatial Gait Parameters Compared to Free Walking in People With Parkinson's Disease

People with Parkinson's Disease(PD) present a series of alterations such as muscle stiffness and motor slowing, which gradually affect the swinging movement of the arms and legs, altering the ability to walk, increasing the risk of falling, and reducing functionality. This implies a higher energy cost and a greater probability of developing freezing of the gait.

Nordic walking (NW) is a form of physical exercise characterized by the use of walking poles, which could contribute positively to arm swing movement and, thus, gait.

This clinical trial aims to compare Nordic Walking with free walking (FW) protocol training and investigate their effects on arm swing and gait parameters in people with PD.

The study hypothesizes that NW training will reduce asymmetry and increase arm swing amplitudes during gait to a greater extent than FW. Also, improvements in arm swing could positively influence lower limb performance during regular gait, increasing gait speed, stride length, functional mobility, and quality of life.

People with PD will complete 24 supervised NW or FW training sessions for 12 weeks. Both trainings will be identical in volume and intensity, the only difference will be the use of poles in the NW group. Blinded researchers will conduct evaluations at baseline (T0), post-intervention (T1), and in one-month follow-up (T2).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary aims: To compare the effects of Nordic Walking (NW) with a free walking (FW) protocol training on arm swing in people with Parkinson's disease.

Secondary aims: To compare the effects of NW and FW protocol training on the performance of lower limbs during walking, functional mobility, and quality of life in people with Parkinson's disease.

Methodology Study design: randomized controlled clinical trial, parallel, single-blinded. The participants will be invited through posters disseminating the research. Each interested person will be contacted by telephone and invited to the Human Movement Sciences Laboratory of the University of Talca. After signing informed consent, the baseline evaluations will be carried out. A brief questionnaire containing bio-demographic information and health history will be completed to verify the inclusion and exclusion criteria. To establish the disease's stage, the Hoehn and Yahr scale will be applied. The cognitive status will be assessed with the Montreal Cognitive Assessment (MoCA).

After the baseline evaluation, a number will be assigned a number to each participant, and performed a randomization process into blocks of four participants to assign them to study groups.

Twenty-eight people with PD, stages 1-3 on the Hoehn and Yahr scale, will be randomly assigned to the NW training (n = 14) or FW training group (n = 14), according to a sample size calculation, with a 1:1 allocation ratio, matched by disease stage (stages I, II, and III). The distribution will be blinded to the evaluators and statisticians.

Interventions:

The training will be developed on the athletics track and trails of the University of Talca, Chile. The participants will be trained in groups (NW or FW), for 12 weeks, two times a week on alternate days, completing 24 one-hour sessions. The protocol will be standardized for both groups.

Two physiotherapists, blinded to the study groups, will conduct the evaluations at T0 (baseline assessment), T1 (after 12 weeks of intervention), and T2 (one-month follow-up).

To characterize the sample, we will collect bio-demographic information and health data. To evaluate the progression of motor and non-motor symptoms in PD, the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be applied. To safeguard the safety of the participants and prescribe the training individually, vital parameters will be assessed. The anthropometric profile will be established through weight, height, and body mass index. The upper and lower limbs' lengths are also measured (m). To assess walking speed, a 10-meter walk test will be applied, and to assess aerobic capacity, a 6-minute walk test will be carried out.

Two accelerometers placed at the wrist level will acquire the arm swing parameters. Arm swing is defined as a rotational movement of the arm, occurring during walking, and running in bipeds in opposite directions (anterior and posterior). With a validated AS algorithm, the amplitude of the arm swing for both upper limbs will be calculated. The arm swing asymmetry will be determined according to the symmetry index, considering the phases of oscillation detected in both arms simultaneously with an equation. The gait temporal-spatial parameters (gait speed and step length) will be acquired under the same test conditions and simultaneously to obtain the arm swing parameters, using a wireless sensor model G-walk® (BTS, Italy). Functional mobility will be measured through the timed up-and-go test (TUG). The quality of life will be assessed through the Parkinson's Disease Questionnaire (PDQ39).

Adherence will be monitored by recording attendance at training sessions. Fully adherent participants will be considered those who attend more than 80% of sessions. Adverse events will be monitored in each session and reported in the results.

Statistic analysis: Descriptive data analysis will be calculated for all variables in both groups at baseline (T0). The normality distribution will be verified. To investigate differences in arm swing parameters, a repeated measures analysis of variance will be performed. To determine intra- and intergroup differences, a Bonferroni post-hoc test will be applied. To estimate the relationship between kinematic parameters and the asymmetry of arm swing with lower limb parameters, Pearson's correlation coefficient will be used. Subsequently, a multiple regression analysis will be performed. In the case of a non-normal distribution, non-parametric tests will be used. For the treatment of missing data, an imputation method using regression will be used. All results with a p-value lower than 0.05 will be considered statistically significant. Additionally, the size of the effect will be determined by Cohen's test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Cristian Caparrós Manosalva, PT, MsC, PhD
  • Phone Number: +56953424032
  • Email: ccaparros@utalca.cl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of idiopathic PD, confirmed by a neurologist following the criteria of the Parkinson disease Society Brain Bank Criteria
  • Age between 50-80 years
  • Disease stage between I and III according to Hoehn and Yahr (Hoehn and Yahr)
  • To be able to walk without technical aids.

Exclusion Criteria:

  • Cognitive impairment (score < 26 in the Montreal Cognitive Assessment MoCA).
  • Surgery lasting less than three months or deep brain stimulation (DBS).
  • Presence of comorbidities that contraindicate moderate to high-intensity physical exercise.
  • Participate in any walking training two or more times per week.
  • Diagnosis of any other neurological or musculoskeletal condition that can cause motor compromise and interfere with locomotion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nordic Walking group
The group will be training with a Nordic Walking protocol for 12- weeks, two times a week, completing 24 one-hour sessions.
Other: Nordic walking training
Participants will receive Nordic walking training (to walk with poles) for 12 weeks, 3x/week.
Active Comparator: Free Walking group
The group will be training with a Free Walking protocol for 12- weeks, two times a week, completing 24 one-hour sessions.
Other: Free Walking training
Participants will receive Free walking training (to walk without poles) for 12 weeks, 3x/week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the amplitude of arm swing
Time Frame: Before, after 12-weeks of training, and after one-month of follow-up.
It is the movement of the arms in the antero-posterior direction during walking. Measurements will be made through accelerometers, and the unit of measurement will be degrees.
Before, after 12-weeks of training, and after one-month of follow-up.
Change in the arm swing asymmetry
Time Frame: Before, after 12-weeks of training, and after one-month of follow-up.
Asymmetry of the amplitude of movement between left and right swings during walking (0% means no asymmetry) [%]
Before, after 12-weeks of training, and after one-month of follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the temporospatial measurements during walking including measurements of Gait speed [m/s] and step length [m].
Time Frame: Before, after 12-weeks of training, and after one-month of follow-up.
will be assessed using wireless IMU sensor model G-walk (BTS, Italy)
Before, after 12-weeks of training, and after one-month of follow-up.
Change in the functional mobility will be measured through the Timed up and go (TUG).
Time Frame: Before, after 12-weeks of training, and after one-month of follow-up.
TUG measures the function of the lower limbs, mobility, and risk of falling. It consists of a measurement of the time taken to complete a circuit of three meters in seconds.
Before, after 12-weeks of training, and after one-month of follow-up.
Change in the quality of life
Time Frame: Before, after 12-weeks and after one-month of follow-up.
Quality of life will be assessed through the Parkinson's Disease Questionnaire (PDQ39)
Before, after 12-weeks and after one-month of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Talca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jéssica Espinoza, PT, MsC, PhD, University of Talca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Parkinson Disease

Clinical Trials on Nordic walking training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings