Wearable Visual Cues in Parkinson's Disease

NCT05478187 | Completed

• 1 other identifier: QWalkTrial
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Parkinson Disease; Movement Disorders; Gait Disorders, Neurologic

Keywords

visual cues; sensory cues; gait; balance; rehabilitation; Parkinson's disease; wearable device

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• CoP sway length (statokinesigram) (mm) change

  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

  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

  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

  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

  Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)

Study Arms (2)

QWalk Study Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

QWalk Study Group DEVICE

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)

Also known as: QWalk

QWalk Study Group

Traditional visual cues - Control group OTHER

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)

Also known as: Traditional cues

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Habilita, Ospedale di Sarnico: lead

Study Sites (1)

Habilita Zingonia

Ciserano, Bergamo, 24040, Italy

Location

Related Publications (5)

• 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.

  PMID: 18607208 BACKGROUND

• 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.

  PMID: 26982614 BACKGROUND

• 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.

  PMID: 27119224 BACKGROUND

• 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.

  PMID: 25306123 BACKGROUND

• 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.

  PMID: 30584154 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michelangelo Bartolo, Md, PhD

  Habilita Zingonia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Neurorehabilitation Unit

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 28, 2022
• Study Start: November 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)