Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790759
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2021-11-18
Brief Title:
Effect of Haptic Cueing on Long-Range Autocorrelations in Parkinsons Disease Gait Variability
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
Effect of Rhythmic Haptic Stimulations on Long-Range Autocorrelations in Parkinsons Disease Gait Variability A Comparison With Auditory Stimulations
Status:
COMPLETED
Status Verified Date:
2023-03
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:
Parkinsons Disease PD patients suffer from gait impairments responsible for falls and bad quality of life reduced speed and stride length randomness in the temporal organization of stride duration variability reduced Long-Range Autocorrelations LRA For years auditory cueing has been used to modulate PD gait and its effect on LRA is known Less is known regarding the effects of haptic cueing on PD gait and especially on LRA This pilot study will compare the spatio-temporal gait parameters and LRA of PD patients tested under three conditions walking without cueing walking with auditory cueing and walking with haptic cueing by means of rhythmic vibrations on the patients wrists
Detailed Description:
1 BACKGROUND Parkinsons disease PD is the second most common degenerative neurological disease PD induces gait disorders that lead to increased risk of falls These falls seriously affect patients quality of life and generate significant health care costs Unfortunately gait disorders do not respond well to drug treatments and their management is mainly based on rehabilitation treatment The rehabilitation approach comprises two steps a functional assessment of locomotor capacities followed by completion of a therapeutic physical exercise program
Like heart rate stride duration varies in the short and long term according to a complex dynamic of temporal variations These variations present long-range autocorrelations LRA the stride duration does not vary randomly but in a structured way The study of LRA is based on complex mathematical methods requiring recording of at least 256 consecutive gait cycles LRA are altered in PD patients whose gait rhythm is excessively random Alteration of LRA is correlated with neurological impairments Hoehn Yahr scale and UPDRS and patients locomotor stability ABC scale BESTest Measurement of LRA would be the first available objective and quantitative biomarker of stability and risk of falling in patients with PD
Guidelines concerning rehabilitation programs for PD patients are based on education prevention of falls and inactivity physical exercises functional training double task complex tasks learning and adaptation strategies such as the use of rhythmic sensory cueing Auditory Cueing AC has been used for years for clinical and research purposes and its effects on spatio-temporal gait parameters and LRA are known Less is know regarding HapticSomatosensory Cueing HC A few research were conducted to study the influence of HC on PD spatio-temporal gait parameters but to the best of our knowledge none has yet addressed its effects on LRA The aim of this present study was to compare PD saptio-temporal gait parameters and LRA under three conditions walking without cueing walking with AC and walking with HC
2 METHODS 21 Participants 10 patients suffering from idiopathic Parkinsons Disease were recruited from the local community and from the Neurology and the Physical and Rehabilitation Medicine outpatient clinics of the Cliniques universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
22 Functional assessment Before the expermientations starts all participants underwent a non harmful assessment including clinical tests and questionnaires
PD patients Age height weight sex most affected side Movement Disorder Society-Unified Parkinson Disease Rating Scale MDS-UPDRS Mini Balance Evaluation Systems Test Mini-BESTest Simplified version of the Activities-specific Balance Confidence Scale ABC-Scale modified Hoehn Yahr scale Mini Mental State Examination MMSE
23 Procedure Every participants walked in three conditions in a randomized order Each condition lasted 10 minutes in order to get 256 gait cycles mandatory to assess the presence of LRA using the evenly spaced averaged version of the Detrended Fluctuations Analysis DFA
The first condition was the control condition CC patients walking without any cueing on a rectangular track with rounded corner of 632 meters in CUSL at their comfortable walking speed
The second condition was the Auditory Cueing Condition ACC and consisted in walking on the same rectangular track using auditory cueing by the mean of a smartphone app called Soundbrenner This app allowed to precisely deliver rhythmic auditory stimulations through earphones paced 10 faster than each patients preferred step frequence assessed before the experiment
The last condition was the Haptic Cueing Condition ACC and consisted in walking on the same rectangular track using haptic cueing by the mean of a vibratory device called Soundbrenner Pulse and attached to each patients wrist located on their most affected side The Soundbrenner app on the smartphone was connected to the Soundbrenner Pulse by Bluetooth to deliver rhythmic vibratory stimulations also paced 10 faster than each patients preferred step frequence the same frequence as during ACC
24 Data acquisition Two Inertial Measurement Units IMU IMeasureU Research VICON USA were taped on patients both lateral malleoli This system allowed to record ankle accelerations at 500 Hz The data were then put on a computer and each peak of acceleration corresponding to each heel strike was detected by software internally developed to determine all stride durations
25 Gait assessment Data were extracted from 256 consecutive gait cycles which is required for LRA computation
251 Spatiotemporal gait variables
Mean gait speed gait cadence and stride length were measured as follow
Mean gait speed ms-1 Total walking distance m Acquisition duration s Gait cadence stepsmin-1 Total number of steps Acquisition duration min Step length m Gait speed ms60Gait cadence stepsmin
252 Stride duration variability Stride duration variability can be assessed 2 ways in terms of magnitude or in terms of organization how stride duration evolves across consecutive gait cycles
2521 Magnitude of the stride duration variability To determine the effect of the RAS on the magnitude of the stride duration variability during 256 gait cycles the mean the standard deviation SD and the coefficient of variation CV SDmean 100 were assessed
2522 Temporal organization of the stride duration variability Temporal organization of stride duration variability were assessed by LRA computation using the evenly spaced averaged version of the Detrended Fluctuation Analysis DFA to obtain α exponent The presence of LRA can be shown with α exponent values between 05 and 1
Data were treated by the mean of CVI Labwindows C
26 Statistical analyses Statistical analyses were conducted using Sigmaplot 13 If the normality test passed a one-way repeated measures ANOVA was applied to determine the effect of the various walking condition on spatiotemporal gait parameters gait speed gait cadence stride length and on linear and nonlinear measures of stride duration variability CV SD H and α exponents If a significant difference between groups was detected with the ANOVA a Holm-Sidak post hoc test was performed to compare each mean with the other means to isolate the groups from each other Effect size between conditions regarding all parameters was assessed using Cohens d
Like heart rate stride duration varies in the short and long term according to a complex dynamic of temporal variations These variations present long-range autocorrelations LRA the stride duration does not vary randomly but in a structured way The study of LRA is based on complex mathematical methods requiring recording of at least 256 consecutive gait cycles LRA are altered in PD patients whose gait rhythm is excessively random Alteration of LRA is correlated with neurological impairments Hoehn Yahr scale and UPDRS and patients locomotor stability ABC scale BESTest Measurement of LRA would be the first available objective and quantitative biomarker of stability and risk of falling in patients with PD
Guidelines concerning rehabilitation programs for PD patients are based on education prevention of falls and inactivity physical exercises functional training double task complex tasks learning and adaptation strategies such as the use of rhythmic sensory cueing Auditory Cueing AC has been used for years for clinical and research purposes and its effects on spatio-temporal gait parameters and LRA are known Less is know regarding HapticSomatosensory Cueing HC A few research were conducted to study the influence of HC on PD spatio-temporal gait parameters but to the best of our knowledge none has yet addressed its effects on LRA The aim of this present study was to compare PD saptio-temporal gait parameters and LRA under three conditions walking without cueing walking with AC and walking with HC
2 METHODS 21 Participants 10 patients suffering from idiopathic Parkinsons Disease were recruited from the local community and from the Neurology and the Physical and Rehabilitation Medicine outpatient clinics of the Cliniques universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
22 Functional assessment Before the expermientations starts all participants underwent a non harmful assessment including clinical tests and questionnaires
PD patients Age height weight sex most affected side Movement Disorder Society-Unified Parkinson Disease Rating Scale MDS-UPDRS Mini Balance Evaluation Systems Test Mini-BESTest Simplified version of the Activities-specific Balance Confidence Scale ABC-Scale modified Hoehn Yahr scale Mini Mental State Examination MMSE
23 Procedure Every participants walked in three conditions in a randomized order Each condition lasted 10 minutes in order to get 256 gait cycles mandatory to assess the presence of LRA using the evenly spaced averaged version of the Detrended Fluctuations Analysis DFA
The first condition was the control condition CC patients walking without any cueing on a rectangular track with rounded corner of 632 meters in CUSL at their comfortable walking speed
The second condition was the Auditory Cueing Condition ACC and consisted in walking on the same rectangular track using auditory cueing by the mean of a smartphone app called Soundbrenner This app allowed to precisely deliver rhythmic auditory stimulations through earphones paced 10 faster than each patients preferred step frequence assessed before the experiment
The last condition was the Haptic Cueing Condition ACC and consisted in walking on the same rectangular track using haptic cueing by the mean of a vibratory device called Soundbrenner Pulse and attached to each patients wrist located on their most affected side The Soundbrenner app on the smartphone was connected to the Soundbrenner Pulse by Bluetooth to deliver rhythmic vibratory stimulations also paced 10 faster than each patients preferred step frequence the same frequence as during ACC
24 Data acquisition Two Inertial Measurement Units IMU IMeasureU Research VICON USA were taped on patients both lateral malleoli This system allowed to record ankle accelerations at 500 Hz The data were then put on a computer and each peak of acceleration corresponding to each heel strike was detected by software internally developed to determine all stride durations
25 Gait assessment Data were extracted from 256 consecutive gait cycles which is required for LRA computation
251 Spatiotemporal gait variables
Mean gait speed gait cadence and stride length were measured as follow
Mean gait speed ms-1 Total walking distance m Acquisition duration s Gait cadence stepsmin-1 Total number of steps Acquisition duration min Step length m Gait speed ms60Gait cadence stepsmin
252 Stride duration variability Stride duration variability can be assessed 2 ways in terms of magnitude or in terms of organization how stride duration evolves across consecutive gait cycles
2521 Magnitude of the stride duration variability To determine the effect of the RAS on the magnitude of the stride duration variability during 256 gait cycles the mean the standard deviation SD and the coefficient of variation CV SDmean 100 were assessed
2522 Temporal organization of the stride duration variability Temporal organization of stride duration variability were assessed by LRA computation using the evenly spaced averaged version of the Detrended Fluctuation Analysis DFA to obtain α exponent The presence of LRA can be shown with α exponent values between 05 and 1
Data were treated by the mean of CVI Labwindows C
26 Statistical analyses Statistical analyses were conducted using Sigmaplot 13 If the normality test passed a one-way repeated measures ANOVA was applied to determine the effect of the various walking condition on spatiotemporal gait parameters gait speed gait cadence stride length and on linear and nonlinear measures of stride duration variability CV SD H and α exponents If a significant difference between groups was detected with the ANOVA a Holm-Sidak post hoc test was performed to compare each mean with the other means to isolate the groups from each other Effect size between conditions regarding all parameters was assessed using Cohens d
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