Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06342271 |
| Other study ID # |
24-2023 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
University of Talca |
| Contact |
Jessica Espinoza, PT, MsC, PhD |
| Phone |
+56991659008 |
| Email |
jeespinoza[@]utalca.cl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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).
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.
