Parkinson DiseaseNCT05478187
Wearable Visual Cues in Parkinson's Disease
A study testing QWalk Study Group in people with Parkinson Disease and Movement Disorders, run by Habilita, Ospedale di Sarnico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Movement Disorders, Gait Disorders, Neurologic
- What is being tested?
- QWalk Study Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- QWalk Study Group, Traditional visual cues - Control group
- Keywords
- visual cues, sensory cues, gait, balance, rehabilitation, Parkinson's disease, wearable device
- Medical subject headings
- Parkinson Disease, Movement Disorders, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QWalk Study GroupDevice
Also called 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 the new wearable cueing system (QWalk)
Traditional visual cues - Control groupOther
Also called Traditional cues
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Traditional visual cues - Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean gait speed (m/s) change
Distance covered by the body in the unit of time
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The projection onto a 2-dimensional space of the trajectory of the centre of pressure (COP) of a person during erect stance
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Nov 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Habilita, Ospedale di Sarnico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelangelo Bartolo, Habilita S.p.A.
- Investigators
- Michelangelo Bartolo, Md, PhD, Principal investigator, Habilita Zingonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478187
- Sponsor's protocol ID
- QWalkTrial
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 18607208Moustafa 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.
PubMed 26982614Cassimatis 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.
PubMed 27119224De 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.
PubMed 25306123Nonnekes 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.
PubMed 30584154
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable Visual Cueing System for Gait Rehabilitation in Parkinson's Disease: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05478187
- Acronym / sponsor ID
- QWalkTrial
- Keywords
- visual cues, sensory cues, gait, balance, rehabilitation, Parkinson's disease, wearable device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Habilita, Ospedale di SarnicoUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| QWalk Study Group | Experimental | Device: QWalk Study Group10 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) |
| Control Group | Active comparator | Other: Traditional visual cues - Control group10 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QWalk Study GroupAlso: QWalk10 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 |
| Traditional visual cues - Control groupAlso: Traditional cues10 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 | Control Group |
Primary outcome
mean gait speed (m/s) change
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)
Distance covered by the body in the unit of time
step length (m) change
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)
Distance measured from the heel print of one foot to the heel print of the other foot
cadence (step/min) change
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)
time of steps per unit time
stance phase duration (%) change
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)
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 frame: Change from baseline (Time 0) at the end of the intervention (2 weeks - Time 1) and at the followup (3 months - Time 2)
Time of the sub-phase between heel contact of the phase to contralateral foot-off
5 secondary outcomes
CoP sway length (statokinesigram) (mm) change
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)
mean CoP position along the anteroposterior direction (Eyes Open) change
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)
mean CoP position along the mediolateral direction (Eyes Open) change
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)
mean CoP position along the anteroposterior direction (Eyes Closed) change
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)
mean CoP position along the mediolateral direction (Eyes Closed) change
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 18607208Boonstra 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.
- Background: PubMed 26982614Moustafa 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.
- Background: PubMed 27119224Cassimatis 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.
- Background: PubMed 25306123De 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.
- Background: PubMed 30584154Nonnekes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelangelo Bartolo, Md, PhD principal investigator
Habilita Zingonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QWalk Study Group in people with Parkinson Disease and Movement Disorders, run by Habilita, Ospedale di Sarnico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean gait speed (m/s) change (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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05478187, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.