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Parkinson DiseaseNCT06342271

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

A study testing Nordic walking training and Free Walking training in people with Parkinson Disease, run by University of Talca.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Nordic walking training and Free Walking training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
No sites listed yet
Study dates
1 Jun 2024to 30 Jun 2025
Phase
Interventional
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Jessica Espinoza, PT, MsC, PhD contact

+56991659008

jeespinoza@utalca.cl

Cristian Caparrós Manosalva, PT, MsC, PhD contact

+56953424032

ccaparros@utalca.cl

About this study

Official title: 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.

Read more

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).

Read the 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.

Being tested
Nordic walking training, Free Walking training
Keywords
Parkinson disease, Arms swing, Gait, Gait Disorders, Neurologic, Nordic Walking, Rehabilitation
Medical subject headings
Parkinson Disease, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nordic walking trainingOther

    Participants will receive Nordic walking training (to walk with poles) for 12 weeks, 3x/week.

  • Free Walking trainingOther

    Participants will receive Free walking training (to walk without poles) for 12 weeks, 3x/week.

Study groups in NCT06342271
Study groupRoleWhat they receive
Nordic Walking groupExperimentalThe group will be training with a Nordic Walking protocol for 12- weeks, two times a week, completing 24 one-hour sessions.
Receives: Other: Nordic walking training
Free Walking groupActive comparatorThe group will be training with a Free Walking protocol for 12- weeks, two times a week, completing 24 one-hour sessions.
Receives: Other: Free Walking training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the amplitude of arm swing

    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.

    Measured: Before, after 12-weeks of training, and after one-month of follow-up.

  2. Change in the arm swing asymmetry

    Asymmetry of the amplitude of movement between left and right swings during walking (0% means no asymmetry) [%]

    Measured: Before, after 12-weeks of training, and after one-month of follow-up.

Secondary outcomes (3)
  1. Change in the temporospatial measurements during walking including measurements of Gait speed [m/s] and step length [m].

    will be assessed using wireless IMU sensor model G-walk (BTS, Italy)

    Measured: Before, after 12-weeks of training, and after one-month of follow-up.

  2. Change in the functional mobility will be measured through the Timed up and go (TUG).

    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.

    Measured: Before, after 12-weeks of training, and after one-month of follow-up.

  3. Change in the quality of life

    Quality of life will be assessed through the Parkinson's Disease Questionnaire (PDQ39)

    Measured: Before, after 12-weeks and after one-month of follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion30 Mar 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342271
Sponsor's protocol ID
24-2023
Status last verified
Mar 2024
First submitted
26 Mar 2024
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Espinoza-Araneda J, Caparros-Manosalva C, da Cunha M, Marzuca-Nassr GN, Fritz-Silva N, Pagnussat AS. Nordic walking and arm swing asymmetry in people with Parkinson's disease: protocol for a randomised clinical trial. BMJ Open Sport Exerc Med. 2024 May 27;10(2):e002029. doi: 10.1136/bmjsem-2024-002029. eCollection 2024.

    PubMed 38808265

Questions about this trial

What is this clinical trial studying?

A study testing Nordic walking training and Free Walking training in people with Parkinson Disease, run by University of Talca.

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 5 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jessica Espinoza, PT, MsC, PhD (+56991659008, jeespinoza@utalca.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the amplitude of arm swing (time frame: Before, after 12-weeks of training, and after one-month of follow-up.). The study lists 2 primary outcomes in all. 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 NCT06342271, 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 2 Apr 2024.

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