Wearable Visual Cues in Parkinson's Disease

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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Movement Disorders; Gait Disorders, Neurologic
• Intervention / Treatment: Device: QWalk Study Group; Other: Traditional visual cues - Control group

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bergamo
    • Ciserano, Bergamo, Italy, 24040
      • Habilita Zingonia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QWalk Study Group; 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; 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); Other Names: QWalk
Active Comparator: Control Group; 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; 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); Other Names: Traditional cues

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Habilita, Ospedale di Sarnico
• Investigators: Principal Investigator: Michelangelo Bartolo, Md, PhD, Habilita Zingonia

Publications and helpful links

General Publications

• Boonstra TA, van der Kooij H, Munneke M, Bloem BR. Gait disorders and balance disturbances in Parkinson's disease: clinical update and pathophysiology. Curr Opin Neurol. 2008 Aug;21(4):461-71. doi: 10.1097/WCO.0b013e328305bdaf.
• Moustafa AA, Chakravarthy S, Phillips JR, Crouse JJ, Gupta A, Frank MJ, Hall JM, Jahanshahi M. Interrelations between cognitive dysfunction and motor symptoms of Parkinson's disease: behavioral and neural studies. Rev Neurosci. 2016 Jul 1;27(5):535-48. doi: 10.1515/revneuro-2015-0070.
• Cassimatis C, Liu KP, Fahey P, Bissett M. The effectiveness of external sensory cues in improving functional performance in individuals with Parkinson's disease: a systematic review with meta-analysis. Int J Rehabil Res. 2016 Sep;39(3):211-8. doi: 10.1097/MRR.0000000000000171.
• De Nunzio A, Zucchella C, Spicciato F, Tortola P, Vecchione C, Pierelli F, Bartolo M. Biofeedback rehabilitation of posture and weightbearing distribution in stroke: a center of foot pressure analysis. Funct Neurol. 2014 Apr-Jun;29(2):127-34.
• Nonnekes J, Nieuwboer A. Towards Personalized Rehabilitation for Gait Impairments in Parkinson's Disease. J Parkinsons Dis. 2018;8(s1):S101-S106. doi: 10.3233/JPD-181464.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: gait; rehabilitation; Parkinson's disease; balance; wearable device; visual cues; sensory cues
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases; Disease; Parkinson Disease; Nervous System Diseases; Movement Disorders; Gait Disorders, Neurologic
• Other Study ID Numbers: QWalkTrial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No