Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453863
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-04-24
Brief Title:
Effects of Biofeedback Footwear in Parkinsons Disease Assessment of Functional Motor Abilities and Locomotion
Sponsor:
IRCCS National Neurological Institute C Mondino Foundation
Organization:
IRCCS National Neurological Institute C Mondino Foundation
Study Overview
Official Title:
Effects of Biofeedback Footwear in Parkinsons Disease Assessment of Functional Motor Abilities and Locomotion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The study aims to verify whether the use of a specific footwear providing increased plantar feedback plantar feedback shoes could improve gait parameters postural control and functional performances in people with Parkinsons disease
Specifically the aims are
To evaluate the acute effect of plantar feedback shoes by comparing gait functional and postural performances in three conditions neutral shoes barefoot and plantar feedback shoes
To evaluate the effect of four weeks of plantar feedback shoes on gait functional and postural performances
Participants will undergo a comprehensive neurological examination with administration of disease-specific scales UPDRS III part 3 NFOG-q LEDD DASS-21 At each assessment the participants will perform an inertial gait analysis a static posturography and will undergo functional capacity assessments TUG 2MWT 5-STST 10- mFW
Specifically the aims are
To evaluate the acute effect of plantar feedback shoes by comparing gait functional and postural performances in three conditions neutral shoes barefoot and plantar feedback shoes
To evaluate the effect of four weeks of plantar feedback shoes on gait functional and postural performances
Participants will undergo a comprehensive neurological examination with administration of disease-specific scales UPDRS III part 3 NFOG-q LEDD DASS-21 At each assessment the participants will perform an inertial gait analysis a static posturography and will undergo functional capacity assessments TUG 2MWT 5-STST 10- mFW
Detailed Description:
Parkinsons Disease PD is a chronic and progressive neurodegenerative condition clinically characterized by the presence of bradykinesia resting tremor rigidity and postural instability Individuals affected by this condition exhibit several gait abnormalities characterized by reduced speed short and shuffling steps and increased step variability
In recent decades efforts have been made towards the development of sustainable and implementable strategies in the daily lives of these individuals aimed at improving posture and gait performances
In this context the role of enhanced plantar biofeedback is under investigation For example plantar sensory stimulation seems to improve postural adjustments and gait Moreover it has been observed that the barefoot contact of the foot with the ground as opposed to wearing a shoe is capable of providing greater feedback thus improving posture and locomotion Improved locomotion leads to increased safety while performing daily living activities a reduction in the risk of falls and therefore an increase in quality of life Studies in the literature are primarily focused on stimulating insoles and footwear with integration of vibratory auditory andor visual biofeedback
The applicability of electronic footwear is currently limited A possible sustainable solution could be the use of footwear that minimizes the separation of the foot from the external environment while effectively protecting it from possible injuries This type of footwear conforms to the shape of the foot potentially allowing for greater plantar feedback when compared to traditional shoes Gait using inertial sensors represents an easily implementable method in research and clinical practice with application in numerous neurological syndromes A device worn at the lumbar level can measure spatiotemporal parameters of gait Moreover it is possible to calculate trunk-derived accelerometric indexes In particular the Harmonic Ratio HR is a representative index of the fluidity and rhythm of physiological gait It is therefore a reliable parameter for evaluating possible gait alterations in neurological patients
The primary aim of the study is to verify whether the use of footwear providing increased plantar feedback improves HR in PD patients
As a secondary aim changes in other trunk-derived gait indexes static postural control and functional capabilities will be evaluated Moreover middle-term changes after four weeks of plantar feedback shoes wearing in these parameteres as well as the occurence of falls and freezing of gait FOG will be assessed
The study is divided into 2 work-packages WP WP1 is an interventional open-label study in which short-term changes induced by footwear providing increased plantar feedback will be observed
At the initial assessment T0 clinical-demographic data will be collected and patients will undergo a comprehensive neurological examination Disease-specific scales UPDRS III part 3 NFOG-q LEDD DASS-21 will be administered
Patients will undergo inertial gait analysis static barefoot posturography and functional performance tests TUG 2MWT 5-STST 10-mFW under three conditions in a randomized order
Barefoot condition BC without wearing any shoes
Neutral condition NC wearing neutral gym shoes
Increased plantar feedback condition PFC wearing plantar shoes
WP2 is a prospective interventional randomized controlled study in which changes induced by the adoption of plantar shoes for four weeks will be evaluated After the baseline evaluations T0 patients will be randomized and assigned to one of the following groups
Neutral condition NC wearing neutral gym shoes
Greater plantar feedback condition PFC wearing plantar shoes
In both groups participants will be provided with appropriately sized shoes and will be asked to adopt the assigned shoes as their usual footwear for everyday activities over a period of four weeks Patients will be required to keep a diary to indicate any issues with the use of the shoes and daily usage time as well as keep record of falls and FOG episodes
Evaluations scheme
Gait analysis procedure
To acquire gait data an inertial sensor BTS G-Walk BTS Milan Italy will be positioned at the level of the fifth lumbar vertebra L5 using an ergonomic belt The inertial sensor communicates with a laptop via Bluetooth for data recording and offline analysis The sensor incorporates a triaxial accelerometer 16 bits axis triaxial magnetometer 13 bits and triaxial gyroscope 16 bitsaxis The sampling frequency is 100 Hz recording linear and angular trunk accelerations in the anteroposterior AP mediolateral ML and vertical V directions
The Walk protocol of the G-STUDIO software G-STUDIO BTS Milan Italy will be used to detect trunk acceleration phases of the right and left step cycles and spatiotemporal parameters of pelvic kinematics The harmonic ratio will be calculated as trunk acceleration data along three directions vertical medio-lateral and anteroposterior decomposing the components of the signal into its harmonics as the ratio between the sum of the first 10 even and the first 10 odd harmonic multiples of the fundamental frequencies
The other Trunk Inertial Indexes calculated will be the largest Lyapunov exponent LLE coefficient of variation CV log dimensionless jerk score LDLJ the recurrence quantification analysis RQA as described in a previous work by Castiglia et al
Before the experimental session participants will be instructed to walk on the ground along a predetermined path to become familiar with the procedure They will be instructed to walk at a pace consistent with their usual gait along a corridor approximately 3 meters wide and 30 meters long in the absence of external factors that may interfere with step cadence and rhythm Five consecutive trials will be performed The trials will be stopped if the patient reports discomfort during the procedure fatigue or pain
Posturographic evaluation
For posturographic evaluation computerized stabilometry will be performed recording the patient in an orthostatic position under quiet conditions and without disturbances with eyes open and eyes closed using force platforms available at our Institute BTS P-6000 BTS Milan Italy Patients will be asked to position themselves on the posturographic platforms Once the position is achieved and it is ensured that the patient is comfortable the technician will record 3 trials of 10 seconds with eyes open and 3 trials of 10 seconds with eyes closed To reduce the learning effect the trials will be recorded in a randomized manner The trials will be stopped if the patient reports discomfort during the procedure fatigue or pain
Administration of Functional Capacity Scales
Timed-Up and Go TUG Test The TUG is a simple test for the assessment of overall motor functionality Participants are asked to rise from a chair walk a linear distance of 3 meters turn 180 degrees and return to a seated position in the shortest time possible
2-minute Walk Test 2MWT The 2MWT evaluates autonomy and aerobic walking capacity In the 2MWT the subject is instructed to cover the greatest distance by walking along a flat 30-meter path within a span of 2 minutes
5 Sit to Stand Test 5-STST The 5-STST is used to assess the functionality and strength of the lower limbs The subject is asked to stand up and sit down from a chair five times in the shortest time possible
10-meter Free Walk 10-mFW In the 10-meter test the subject is asked to walk along a flat 10-meter path at a perceived comfortable usual pace
Statistical Plan A preliminary normality analysis will be conducted to determine whether to use parametric or non-parametric methods using graphical representation and the Shapiro-Wilk test Numeric variables will be described in terms of mean and standard deviation or median and quartiles if appropriate while categorical variables will be presented as raw count and percentage
Within WP1 the three groups will be compared using ANOVA with Bonferroni post-hoc tests or Friedman tests for dependent samples
Correlations with quantitative parameters will be assessed using the Pearson correlation coefficient or Spearman if necessary both within groups and globally
Within WP2 changes in HR will be evaluated with repeated measures ANOVA or a similar non-parametric test with two factors TIME 2 levels T0 vs T1 within groups and GROUP 2 levels plantar shoe vs neutral shoe between groups
In recent decades efforts have been made towards the development of sustainable and implementable strategies in the daily lives of these individuals aimed at improving posture and gait performances
In this context the role of enhanced plantar biofeedback is under investigation For example plantar sensory stimulation seems to improve postural adjustments and gait Moreover it has been observed that the barefoot contact of the foot with the ground as opposed to wearing a shoe is capable of providing greater feedback thus improving posture and locomotion Improved locomotion leads to increased safety while performing daily living activities a reduction in the risk of falls and therefore an increase in quality of life Studies in the literature are primarily focused on stimulating insoles and footwear with integration of vibratory auditory andor visual biofeedback
The applicability of electronic footwear is currently limited A possible sustainable solution could be the use of footwear that minimizes the separation of the foot from the external environment while effectively protecting it from possible injuries This type of footwear conforms to the shape of the foot potentially allowing for greater plantar feedback when compared to traditional shoes Gait using inertial sensors represents an easily implementable method in research and clinical practice with application in numerous neurological syndromes A device worn at the lumbar level can measure spatiotemporal parameters of gait Moreover it is possible to calculate trunk-derived accelerometric indexes In particular the Harmonic Ratio HR is a representative index of the fluidity and rhythm of physiological gait It is therefore a reliable parameter for evaluating possible gait alterations in neurological patients
The primary aim of the study is to verify whether the use of footwear providing increased plantar feedback improves HR in PD patients
As a secondary aim changes in other trunk-derived gait indexes static postural control and functional capabilities will be evaluated Moreover middle-term changes after four weeks of plantar feedback shoes wearing in these parameteres as well as the occurence of falls and freezing of gait FOG will be assessed
The study is divided into 2 work-packages WP WP1 is an interventional open-label study in which short-term changes induced by footwear providing increased plantar feedback will be observed
At the initial assessment T0 clinical-demographic data will be collected and patients will undergo a comprehensive neurological examination Disease-specific scales UPDRS III part 3 NFOG-q LEDD DASS-21 will be administered
Patients will undergo inertial gait analysis static barefoot posturography and functional performance tests TUG 2MWT 5-STST 10-mFW under three conditions in a randomized order
Barefoot condition BC without wearing any shoes
Neutral condition NC wearing neutral gym shoes
Increased plantar feedback condition PFC wearing plantar shoes
WP2 is a prospective interventional randomized controlled study in which changes induced by the adoption of plantar shoes for four weeks will be evaluated After the baseline evaluations T0 patients will be randomized and assigned to one of the following groups
Neutral condition NC wearing neutral gym shoes
Greater plantar feedback condition PFC wearing plantar shoes
In both groups participants will be provided with appropriately sized shoes and will be asked to adopt the assigned shoes as their usual footwear for everyday activities over a period of four weeks Patients will be required to keep a diary to indicate any issues with the use of the shoes and daily usage time as well as keep record of falls and FOG episodes
Evaluations scheme
Gait analysis procedure
To acquire gait data an inertial sensor BTS G-Walk BTS Milan Italy will be positioned at the level of the fifth lumbar vertebra L5 using an ergonomic belt The inertial sensor communicates with a laptop via Bluetooth for data recording and offline analysis The sensor incorporates a triaxial accelerometer 16 bits axis triaxial magnetometer 13 bits and triaxial gyroscope 16 bitsaxis The sampling frequency is 100 Hz recording linear and angular trunk accelerations in the anteroposterior AP mediolateral ML and vertical V directions
The Walk protocol of the G-STUDIO software G-STUDIO BTS Milan Italy will be used to detect trunk acceleration phases of the right and left step cycles and spatiotemporal parameters of pelvic kinematics The harmonic ratio will be calculated as trunk acceleration data along three directions vertical medio-lateral and anteroposterior decomposing the components of the signal into its harmonics as the ratio between the sum of the first 10 even and the first 10 odd harmonic multiples of the fundamental frequencies
The other Trunk Inertial Indexes calculated will be the largest Lyapunov exponent LLE coefficient of variation CV log dimensionless jerk score LDLJ the recurrence quantification analysis RQA as described in a previous work by Castiglia et al
Before the experimental session participants will be instructed to walk on the ground along a predetermined path to become familiar with the procedure They will be instructed to walk at a pace consistent with their usual gait along a corridor approximately 3 meters wide and 30 meters long in the absence of external factors that may interfere with step cadence and rhythm Five consecutive trials will be performed The trials will be stopped if the patient reports discomfort during the procedure fatigue or pain
Posturographic evaluation
For posturographic evaluation computerized stabilometry will be performed recording the patient in an orthostatic position under quiet conditions and without disturbances with eyes open and eyes closed using force platforms available at our Institute BTS P-6000 BTS Milan Italy Patients will be asked to position themselves on the posturographic platforms Once the position is achieved and it is ensured that the patient is comfortable the technician will record 3 trials of 10 seconds with eyes open and 3 trials of 10 seconds with eyes closed To reduce the learning effect the trials will be recorded in a randomized manner The trials will be stopped if the patient reports discomfort during the procedure fatigue or pain
Administration of Functional Capacity Scales
Timed-Up and Go TUG Test The TUG is a simple test for the assessment of overall motor functionality Participants are asked to rise from a chair walk a linear distance of 3 meters turn 180 degrees and return to a seated position in the shortest time possible
2-minute Walk Test 2MWT The 2MWT evaluates autonomy and aerobic walking capacity In the 2MWT the subject is instructed to cover the greatest distance by walking along a flat 30-meter path within a span of 2 minutes
5 Sit to Stand Test 5-STST The 5-STST is used to assess the functionality and strength of the lower limbs The subject is asked to stand up and sit down from a chair five times in the shortest time possible
10-meter Free Walk 10-mFW In the 10-meter test the subject is asked to walk along a flat 10-meter path at a perceived comfortable usual pace
Statistical Plan A preliminary normality analysis will be conducted to determine whether to use parametric or non-parametric methods using graphical representation and the Shapiro-Wilk test Numeric variables will be described in terms of mean and standard deviation or median and quartiles if appropriate while categorical variables will be presented as raw count and percentage
Within WP1 the three groups will be compared using ANOVA with Bonferroni post-hoc tests or Friedman tests for dependent samples
Correlations with quantitative parameters will be assessed using the Pearson correlation coefficient or Spearman if necessary both within groups and globally
Within WP2 changes in HR will be evaluated with repeated measures ANOVA or a similar non-parametric test with two factors TIME 2 levels T0 vs T1 within groups and GROUP 2 levels plantar shoe vs neutral shoe between groups
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