Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342271
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
Effects of Nordic Walking and Free Walking on Arm Swing Parameters and Gait in Parkinsons Disease
Sponsor:
University of Talca
Organization:
University of Talca
Study Overview
Official Title:
Effects of a Nordic Walking Program on Arm Swing Asymmetry and Temporospatial Gait Parameters Compared to Free Walking in People With Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People with Parkinsons DiseasePD 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
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
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 Parkinsons 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 Parkinsons 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 diseases 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 11 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 Parkinsons 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 Parkinsons 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 Pearsons 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 005 will be considered statistically significant Additionally the size of the effect will be determined by Cohens test
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 Parkinsons 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 diseases 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 11 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 Parkinsons 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 Parkinsons 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 Pearsons 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 005 will be considered statistically significant Additionally the size of the effect will be determined by Cohens test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None