search
Back to results

Wearable Visual Cues in Parkinson's Disease

Primary Purpose

Parkinson Disease, Movement Disorders, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
QWalk Study Group
Traditional visual cues - Control group
Sponsored by
Habilita, Ospedale di Sarnico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring visual cues, sensory cues, gait, balance, rehabilitation, Parkinson's disease, wearable device

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Habilita Zingonia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QWalk Study Group

Control Group

Arm Description

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)

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

Outcomes

Primary Outcome Measures

mean gait speed (m/s) change
Distance covered by the body in the unit of time
step length (m) change
Distance measured from the heel print of one foot to the heel print of the other foot
cadence (step/min) change
time of steps per unit time
stance phase duration (%) change
time interval between two consecutive foot strikes of the same lower limb expressed as a percentage of the stride duration
double support phase duration (%) change
Time of the sub-phase between heel contact of the phase to contralateral foot-off

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
July 24, 2022
Last Updated
July 26, 2022
Sponsor
Habilita, Ospedale di Sarnico
search

1. Study Identification

Unique Protocol Identification Number
NCT05478187
Brief Title
Wearable Visual Cues in Parkinson's Disease
Official Title
A Wearable Visual Cueing System for Gait Rehabilitation in Parkinson's Disease: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Habilita, Ospedale di Sarnico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Movement Disorders, Gait Disorders, Neurologic
Keywords
visual cues, sensory cues, gait, balance, rehabilitation, Parkinson's disease, wearable device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QWalk Study Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
QWalk Study Group
Other Intervention Name(s)
QWalk
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Traditional visual cues - Control group
Other Intervention Name(s)
Traditional cues
Intervention Description
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)
Primary Outcome Measure Information:
Title
mean gait speed (m/s) change
Description
Distance covered by the body in the unit of time
Time Frame
Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Title
step length (m) change
Description
Distance measured from the heel print of one foot to the heel print of the other foot
Time Frame
Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Title
cadence (step/min) change
Description
time of steps per unit time
Time Frame
Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Title
stance phase duration (%) change
Description
time interval between two consecutive foot strikes of the same lower limb expressed as a percentage of the stride duration
Time Frame
Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Title
double support phase duration (%) change
Description
Time of the sub-phase between heel contact of the phase to contralateral foot-off
Time Frame
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 Measure Information:
Title
CoP sway length (statokinesigram) (mm) change
Description
The projection onto a 2-dimensional space of the trajectory of the centre of pressure (COP) of a person during erect stance
Time Frame
Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Title
mean CoP position along the anteroposterior direction (Eyes Open) change
Description
the centroid of all the external forces acting on the plantar surface of the foot
Time Frame
Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Title
mean CoP position along the mediolateral direction (Eyes Open) change
Description
the centroid of all the external forces acting on the plantar surface of the foot
Time Frame
Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Title
mean CoP position along the anteroposterior direction (Eyes Closed) change
Description
the centroid of all the external forces acting on the plantar surface of the foot
Time Frame
Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Title
mean CoP position along the mediolateral direction (Eyes Closed) change
Description
the centroid of all the external forces acting on the plantar surface of the foot
Time Frame
Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelangelo Bartolo, Md, PhD
Organizational Affiliation
Habilita Zingonia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Habilita Zingonia
City
Ciserano
State/Province
Bergamo
ZIP/Postal Code
24040
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18607208
Citation
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.
Results Reference
background
PubMed Identifier
26982614
Citation
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.
Results Reference
background
PubMed Identifier
27119224
Citation
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.
Results Reference
background
PubMed Identifier
25306123
Citation
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.
Results Reference
background
PubMed Identifier
30584154
Citation
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.
Results Reference
background

Learn more about this trial

Wearable Visual Cues in Parkinson's Disease

We'll reach out to this number within 24 hrs