Ignite Creation Date:
2024-05-06 @ 5:55 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05478187
Status:
COMPLETED
Last Update Posted:
2022-07-28
First Post:
2022-07-24
Brief Title:
Wearable Visual Cues in Parkinsons Disease
Sponsor:
Habilita Ospedale di Sarnico
Organization:
Habilita Ospedale di Sarnico
Study Overview
Official Title:
A Wearable Visual Cueing System for Gait Rehabilitation in Parkinsons Disease a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-07
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:
One of the most disabling features of Parkinsons disease PD is represented by the gait disturbances Some systematic reviews and meta-analysis have showed that conventional physical therapy might improve gait as well as balance mobility and functional reach in subjects affected by PD In addition several studies and reviews support the effectiveness of external sensory cueing by means of rhythmic auditory or visual cues in improving kinematic parameters of gait gait cadence stride length velocity and postural stability and the functional performance in people with PD at least in the short-term Specifically cueing refers to the use of temporal or spatial stimuli to regulate movement and facilitate functional performance for individual with motor dysfunction Basal ganglia act as internal triggers of neuronal activity in the supplementary motor area for well-learned automatic movement sequences such as locomotion This mechanism is damaged in individuals with PD and external cues may act as an attention resource to compensate the deficient internal rhythm due to basal ganglia dysfunction Subjects can be coached in concentrating their attention on gait by specific self-prompting instructions or by cues stimulation or a combination of these Movements generated by the presence of external sensory cues are prompted to use alternative cortical parieto-premotor neuronal pathways which have not been damaged by neuronal degeneration of PD bypassing the automatic basal ganglia network Recent studies have provided preliminary evidence that visual cueing based on laser shoes and laser canes may reduce freezing an established risk for falls with improvement that can be observed for a variable period of time after rehabilitative intervention In light of the evidence of effectiveness of cueing developing wearable devices able to generate cues that match with step and that are effective easy to use and low cost would be challenging but very appropriate The aim of this study was to investigate the non-inferiority of a wearable device producing visual cues Q-Walk system QUICKLYPRO srl Bergamo Italy in order to improve gait and balance PD patients compared to a conventional training stripes on the floor
Detailed Description:
All patients consecutively referred to the Neurorehabilitation Unit of HABILITA between 1st November 2019 and 31th December 2021 were screened Patient were admitted for outpatients rehabilitation All particpants could walk independently without walking device All patients were taking oral administration of levodopa dopamine agonists or both and were evaluated in ON phase
All the patients gave their written informed consent to take part in the study The study was approved by the Local Ethics Committee of Bergamo Reg Sper n 17819 11102019 and was carried out in accordance with The Code of Ethics of the World Medical Association Declaration of Helsinki for experiments involving humans
All the patients gave their written informed consent to take part in the study The study was approved by the Local Ethics Committee of Bergamo Reg Sper n 17819 11102019 and was carried out in accordance with The Code of Ethics of the World Medical Association Declaration of Helsinki for experiments involving humans
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