Wearable Visual Cues in Parkinson's Disease

Study Overview
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Brief Summary
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One of the most disabling features of Parkinson's 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 s.r.l., Bergamo, Italy) in order to improve gait and balance PD patients, compared to a conventional training (stripes on the floor).

Detailed Description
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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. 178/19, 11/10/2019) and was carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans.

Official Title
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A Wearable Visual Cueing System for Gait Rehabilitation in Parkinson's Disease: a Randomized Controlled Trial.

Conditions
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Parkinson Disease, Movement Disorders, Gait Disorders, Neurologic

Intervention / Treatment
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* Device: QWalk Study Group
* Other: Traditional visual cues - Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of idiopathic PD (defined by the UK Brain Bank Criteria); absence of cognitive impairment (Mini-Mental State Examination score ≥ 24); Hoehn & Yahr stage II-IV; mild to severe gait disturbance with score ≥2 at the Unified Parkinson's Disease Rating Scale (UPDRS) motor section III; stable drug usage since at least 3 weeks. Exclusion Criteria: past history or current presence of neurological conditions other than PD; orthopedic or visual disturbances severely impairing walking ability; previous deep brain stimulation or other neurosurgery; participation in a rehabilitation program within 2 months before the trial and previous use of cues for gait rehabilitation.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QWalk Study Group<br>10 individual sessions (5 sessions/week for 2 consecutive weeks). Each session consisted of 60 minutes of conventional physiotherapy plus an additional session of gait training (30 minutes), performed by means of the new wearable cueing system (QWalk) | Device: QWalk Study Group<br>* 10 individual sessions (5 sessions/week for 2 consecutive weeks). Each session consisted of 60 minutes of conventional physiotherapy plus an additional session of gait training (30 minutes), performed by means of the new wearable cueing system (QWalk)<br>* Other names: QWalk;|
| Active Comparator: Control Group<br>10 individual sessions (5 sessions/week for 2 consecutive weeks). Each session consisted of 60 minutes of conventional physiotherapy plus an additional session of gait training (30 minutes), performed by means of traditional visual cues consisting of stripes on the floor | Other: Traditional visual cues - Control group<br>* 10 individual sessions (5 sessions/week for 2 consecutive weeks). Each session consisted of 60 minutes of conventional physiotherapy plus an additional session of gait training (30 minutes), performed by means of the traditional cues (stripes on the floor)<br>* Other names: Traditional cues;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean gait speed (m/s) change | Distance covered by the body in the unit of time | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 
| step length (m) change | Distance measured from the heel print of one foot to the heel print of the other foot | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 
| cadence (step/min) change | time of steps per unit time | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 
| stance phase duration (%) change | time interval between two consecutive foot strikes of the same lower limb expressed as a percentage of the stride duration | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 
| double support phase duration (%) change | Time of the sub-phase between heel contact of the phase to contralateral foot-off | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CoP sway length (statokinesigram) (mm) change | The projection onto a 2-dimensional space of the trajectory of the centre of pressure (COP) of a person during erect stance | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 
| mean CoP position along the anteroposterior direction (Eyes Open) change | the centroid of all the external forces acting on the plantar surface of the foot | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 
| mean CoP position along the mediolateral direction (Eyes Open) change | the centroid of all the external forces acting on the plantar surface of the foot | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 
| mean CoP position along the anteroposterior direction (Eyes Closed) change | the centroid of all the external forces acting on the plantar surface of the foot | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 
| mean CoP position along the mediolateral direction (Eyes Closed) change | the centroid of all the external forces acting on the plantar surface of the foot | Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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visual cues, sensory cues, gait, balance, rehabilitation, Parkinson's disease, wearable device