Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921748
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2021-06-04
Brief Title:
Neurorehabilitation of Sequence Effect in Parkinsons Disease
Sponsor:
IRCCS National Neurological Institute C Mondino Foundation
Organization:
IRCCS National Neurological Institute C Mondino Foundation
Study Overview
Official Title:
Destination Sequence Effect Modifications After a 4-week Rehabilitation Program in Parkinsons Diseases Patients
Status:
COMPLETED
Status Verified Date:
2021-06
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 sequence effect SE defined as a reduction in amplitude of repetitive movements is a common clinical feature of Parkinsons disease PD being a major contributor to freezing of gait FOG During walking SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination dSE The investigators studied the effect of a 4-week rehabilitation program on the destination sequence effect in patients affected by Parkinsons disease with and without Freezing of Gait All subjects were evaluated with inertial gait analysis for dSE recording
Detailed Description:
Gait impairment and freezing of gait FOG represent common and disabling symptoms of Parkinsons disease PD The antiparkinsonian therapy positively modulates a subset of gait parameters such as speed of gait and stride length while its impact on FOG is limited Growing evidence supports the efficacy of neurorehabilitation in the treatment of PD across all phases of the disease In the last years the advent of reliable wearable devices has prompted the widespread study of several parameters of the parkinsonian gait in both clinical and research settings
The sequence effect SE defined as a reduction in amplitude of repetitive movements is a common clinical feature of several tasks of patients affected by PD being identifiable in early as well as advanced stages of the disease During walking SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination destination sequence effect - dSE SE is specifically pronounced in PD patients affected by FOG and it arises immediately before a FOG episode induced by a turning or a dual-task
SE may be acutely modulated by several rehabilitative strategies such as split-belt treadmill and reinforcement of visual cues but not by repetitive transcranial magnetic stimulation rTMS antiparkinsonian drugs administration and attention strategies did not influence the SE the evidence on the role of neurorehabilitation on gait SE improvement and retention is extremely scarce
The investigators plan to enroll 43 subjects according to sample size calculation Patients will be divided into two groups patients with freezing of gait FOG and without FOG The subjects will be divided into two groups 1 patients with freezing of gait PDFOG or 2 patients without freezing of gait PD-FOG FOG phenotype is defined as a score between 1 and 4 at either item 213 Freezing or item 311 Freezing of gait of the Unified Parkinson Disease Rating Scale UPDRS
All patients will be treated with a standardized 4-week rehabilitation in-hospital program At hospital admission T0 patients who fulfill inclusionexclusion criteria will be tested with instrumental gait analysis and administration of a set of the following clinical scales rating of PD related motor disability with the Unified Parkinsons Disease Rating Scale - part III UPDRS-III rating of functional independence as measured through the Functional Independence Measure FIM and rating of dependence in activity of daily living according to Barthel Index
After that patients will be treated with 90-minute daily rehabilitative sessions 6 days a week Monday through Saturday for four weeks passive active-assisted and active exercises isotonic and isometric exercises for the major muscles of the limbs and trunk cardiovascular warm-up exercises muscle stretching exercises for functional purposes balance training exercises specific motor exercise for hypokinesia and 45 minutes of overground gait training delivered without devices or cueing The rehabilitation program will be the same in PDFOG and PD-FOG groups At the end of the rehabilitation program T1 the patients will complete the study procedure with a second instrumental gait analysis evaluation and the administration of the same set of clinical scales No modifications of the drug regimen were allowed during the study
The gait analysis will be performed with wearable wireless inertial system secured to the back of the patients between L5 and S1 vertebrae All subjects will be recorded in the morning between 900 am and 1100 am and in the ON condition The investigators plan to record a walk at a comfortable pace of 20 meters The subjects will stop independently at the end of the 20-meter pathway clearly marked by a straight line on the ground Gait assessments with episodes of freezing of gait or pauses will be discrded For each subject three optimal performed gait assessments will be recorded Regarding gait parameters the investigators will record speed ms cadence stepsminute stride length meter step length meter stride duration second single support double support swing duration stance duration percentage stride distribution The destination Sequence Effect dSE will be computed as a regression slope β of step length according to a previously described and validated methodology where step length is plotted against step number Briefly the length of the last six steps ahead of the final stride are plotted against the step number and the linear regression slope β will represent a measure of dSE In addition the intercept I of the regression curve will be used as an indirect measure of gait hypokinesia For each group the relationship between gait hypokinesia and sequence effect is expressed by the function of the linear regression as follow y β x I
The sequence effect SE defined as a reduction in amplitude of repetitive movements is a common clinical feature of several tasks of patients affected by PD being identifiable in early as well as advanced stages of the disease During walking SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination destination sequence effect - dSE SE is specifically pronounced in PD patients affected by FOG and it arises immediately before a FOG episode induced by a turning or a dual-task
SE may be acutely modulated by several rehabilitative strategies such as split-belt treadmill and reinforcement of visual cues but not by repetitive transcranial magnetic stimulation rTMS antiparkinsonian drugs administration and attention strategies did not influence the SE the evidence on the role of neurorehabilitation on gait SE improvement and retention is extremely scarce
The investigators plan to enroll 43 subjects according to sample size calculation Patients will be divided into two groups patients with freezing of gait FOG and without FOG The subjects will be divided into two groups 1 patients with freezing of gait PDFOG or 2 patients without freezing of gait PD-FOG FOG phenotype is defined as a score between 1 and 4 at either item 213 Freezing or item 311 Freezing of gait of the Unified Parkinson Disease Rating Scale UPDRS
All patients will be treated with a standardized 4-week rehabilitation in-hospital program At hospital admission T0 patients who fulfill inclusionexclusion criteria will be tested with instrumental gait analysis and administration of a set of the following clinical scales rating of PD related motor disability with the Unified Parkinsons Disease Rating Scale - part III UPDRS-III rating of functional independence as measured through the Functional Independence Measure FIM and rating of dependence in activity of daily living according to Barthel Index
After that patients will be treated with 90-minute daily rehabilitative sessions 6 days a week Monday through Saturday for four weeks passive active-assisted and active exercises isotonic and isometric exercises for the major muscles of the limbs and trunk cardiovascular warm-up exercises muscle stretching exercises for functional purposes balance training exercises specific motor exercise for hypokinesia and 45 minutes of overground gait training delivered without devices or cueing The rehabilitation program will be the same in PDFOG and PD-FOG groups At the end of the rehabilitation program T1 the patients will complete the study procedure with a second instrumental gait analysis evaluation and the administration of the same set of clinical scales No modifications of the drug regimen were allowed during the study
The gait analysis will be performed with wearable wireless inertial system secured to the back of the patients between L5 and S1 vertebrae All subjects will be recorded in the morning between 900 am and 1100 am and in the ON condition The investigators plan to record a walk at a comfortable pace of 20 meters The subjects will stop independently at the end of the 20-meter pathway clearly marked by a straight line on the ground Gait assessments with episodes of freezing of gait or pauses will be discrded For each subject three optimal performed gait assessments will be recorded Regarding gait parameters the investigators will record speed ms cadence stepsminute stride length meter step length meter stride duration second single support double support swing duration stance duration percentage stride distribution The destination Sequence Effect dSE will be computed as a regression slope β of step length according to a previously described and validated methodology where step length is plotted against step number Briefly the length of the last six steps ahead of the final stride are plotted against the step number and the linear regression slope β will represent a measure of dSE In addition the intercept I of the regression curve will be used as an indirect measure of gait hypokinesia For each group the relationship between gait hypokinesia and sequence effect is expressed by the function of the linear regression as follow y β x I
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