Parkinson DiseaseNCT04799613
Provocation of Freezing of Gait in Parkinson's Disease
A study testing walking speed, visual loading and dual task in people with Parkinson Disease and Freezing of Gait, run by University of Toronto at 1 site in Canada.
Trial summary
Sample Size N= 10 Parkinson's disease patients with self-reported freezing of gait and 10 without self-reported freezing of gait (in total, 20 Parkinson's disease patients) Accrual Period Single visit for 2 hours Study Design This is a cross-sectional study with an intervention to provoke freezing of gait using… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Parkinson Disease, Freezing of Gait
- What is being tested?
- walking speed, visual loading and dual task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2021to 15 Jun 2022
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
- Hoehn \& Yahr Stage 1-3
- Ten with self-reported freezing of gait (score of 1 in part 1 of new freezing of gait questionnaire), and 10 without FOG..
- Sequence effect on feet (as score of at least 2 in the leg agility (item#3.8) of Movement Disorders Society-Unified Parkinson's disease rating scale part 3)
- Stable clinical response to medications or stimulation parameters for at least 1 months
- Able to walk on a motor-driven treadmill
- Ability to provide informed consent
Who cannot join
- Severe imbalance that limits ambulation (Hoehn \&Yahr score above 4)
- Orthostatic hypotension
- Orthopedic conditions and other systemic disease affecting locomotion
- Shortness of breath and cardiac disease
- Psychiatric disorders needing medication
- Dementia
- Presence of other neurological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experimentally-induced Freezing of Gait in Parkinson's Disease by Modulating Step Length/Asymmetry and Cognitive/Visual Loading
Sample Size N= 10 Parkinson's disease patients with self-reported freezing of gait and 10 without self-reported freezing of gait (in total, 20 Parkinson's disease patients)
Accrual Period Single visit for 2 hours
Read more
Study Design This is a cross-sectional study with an intervention to provoke freezing of gait using split-belt treadmill in Parkinson's disease patients with a randomized cross-over design.
After baseline evaluation (a), interventions to induce freezing of gait will be performed in a randomized order to avoid a practice/fatigue effect in the following conditions using combination of 4 interventions: walking speed (fast walking vs. natural walking), visual loading (passing through narrow pathway), cognitive loading (dual task), and asymmetry (best side reduction).
- Natural and fast walking with self-paced mode to access gait parameters and decide the speed for evaluation (3 mins X2) remaining assessment will be randomized and performed on the treadmill:
- Natural and fast walking passing through narrow pathway (2 mins X2)
- Natural and fast walking with dual task (2 mins X2)
- Natural and fast walking passing through narrow pathway and during cognitive dual task (2 mins X2)
- Natural and fast walking reducing the best side (2 mins X2)
- Natural and fast walking reducing the best side passing through narrow pathway (2 mins X2)
- Natural and fast walking reducing the best side with cognitive dual task (2 mins X2)
- Natural and fast walking reducing the best side passing through narrow pathway and during cognitive dual task (2 mins X2)
- Conditions b-h will be carried out on a split-belt treadmill (Grail systems®, by Motek, Netherlands).
- (b-i) freezing of gait episodes will be identified with synchronized videorecordings (screening done by two independent observers). Episodes identified by both observers will be confirmed and measured by comparing the relative height of metatarsal and heel markers of each foot, in keeping with a previous study evaluating freezing of gait episode on a treadmill.
Study Duration
- (Baselines evaluation) Enrolment and assessment (Montreal cognitive assessment, Movement Disorders Society-unified Parkinson's disease rating scale part 2, 3 and 4, Activities-Specific Balance Confidence Scale, Parkinson's disease questionnaire-39, and New freezing of gait questionnaire)
- (a) Formal gait analysis using split-belt treadmill (Grail systems®, by Motek, Netherlands) will be done for baseline assessment (normal walking) and to test patient's ability for fast walking (25% of the normal speed).
- (b-h) Provocation of freezing of gait at split-belt treadmill (Grail systems®, by Motek, Netherlands) with natural and fast walking with/without additional loading or interventions on the asymmetry
Total time= 2 hours
Study Intervention Freezing of gait will be provoked based on the situations combined among 4 conditions; (1) interventions on asymmetry, (2) cognitive dual task, (3) visual loading - passing through narrow pathway, and (4) walking speed at a split-belt treadmill.
- Fast walking will be defined as walking 25% faster than the normal comfortable walking. Subjects who cannot reach this speed, will be asked to walk at their safest maximum speed.
- Passing narrow pathway will be done by walking in a "rope bridge" scene in virtual reality (VR).
- Dual cognitive task will be carried out with serial subtraction prompted on the screen in VR.
- Best side reduction will be defined as 25% slower speed on the best side based on the speed during the initial natural walking with tied configuration setting based on a previous study.3
- Condition b-h will be randomized.
- Conditions
- Parkinson Disease, Freezing of Gait
- Being tested
- walking speed, visual loading, dual task, best side reduction
- Keywords
- Parkinson, freezing, spilt-belt, Dual task, visual
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking speedOther
walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
visual loadingOther
visual loading (walking through narrow pathway using VR)
dual taskOther
dual task (serial subtraction using VR)
best side reductionOther
best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
| Study group | Role | What they receive |
|---|---|---|
| Natural walking | No intervention | Not described |
| fast walking | Experimental | Not described Receives: Other: walking speed |
| normal walking passing through narrow pathway | Experimental | Not described Receives: Other: visual loading |
| fast walking passing through narrow pathway | Experimental | Not described Receives: Other: walking speed; Other: visual loading |
| Natural walking with dual task | Experimental | Not described Receives: Other: dual task |
| fast walking with dual task | Experimental | Not described Receives: Other: walking speed; Other: dual task |
| Natural walking passing through narrow pathway and during cognitive dual task | Experimental | Not described Receives: Other: visual loading; Other: dual task |
| fast walking passing through narrow pathway and during cognitive dual task | Experimental | Not described Receives: Other: walking speed; Other: visual loading; Other: dual task |
| Natural walking reducing the best side | Experimental | Not described Receives: Other: best side reduction |
| fast walking reducing the best side | Experimental | Not described Receives: Other: walking speed; Other: best side reduction |
| Natural walking reducing the best side passing through narrow pathway | Experimental | Not described Receives: Other: visual loading; Other: best side reduction |
| fast walking reducing the best side passing through narrow pathway | Experimental | Not described Receives: Other: walking speed; Other: visual loading; Other: best side reduction |
| Natural walking reducing the best side with cognitive dual task | Experimental | Not described Receives: Other: dual task; Other: best side reduction |
| fast walking reducing the best side with cognitive dual task | Experimental | Not described Receives: Other: walking speed; Other: dual task; Other: best side reduction |
| Natural walking reducing the best side passing through narrow pathway and during cognitive dual task | Experimental | Not described Receives: Other: visual loading; Other: dual task; Other: best side reduction |
| fast walking reducing the best side passing through narrow pathway and during cognitive dual task | Experimental | Not described Receives: Other: walking speed; Other: visual loading; Other: dual task; Other: best side reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of freezing of gait
provoked freezing of gait during each situation
Measured: Within intervention (2mins for each situation)
Secondary outcomes (2)
Correlation with Montreal cognitive assessment, Movement Disorders Society-unified Parkinson's disease rating scale part 2 and 3, Activities-Specific Balance Confidence Scale, Parkinson's disease questionnaire-39, and New freezing of gait questionnaire
Correlation of detected number of freezing of gait with clinical scales
Measured: Within intervention (2mins for each situation)
Comparison of number/duration of provoked freezing of gait among the situations between Parkinson's disease patients with and without freezing of gait
Comparison between two groups
Measured: Within intervention (2mins for each situation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start15 Mar 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fasano, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799613
- Sponsor's protocol ID
- 19-6049-B
- Status last verified
- Jul 2024
- First submitted
- 11 Mar 2021
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nieuwboer A, Rochester L, Herman T, Vandenberghe W, Emil GE, Thomaes T, Giladi N. Reliability of the new freezing of gait questionnaire: agreement between patients with Parkinson's disease and their carers. Gait Posture. 2009 Nov;30(4):459-63. doi: 10.1016/j.gaitpost.2009.07.108. Epub 2009 Aug 5.
PubMed 19660949Fasano A, Herzog J, Seifert E, Stolze H, Falk D, Reese R, Volkmann J, Deuschl G. Modulation of gait coordination by subthalamic stimulation improves freezing of gait. Mov Disord. 2011 Apr;26(5):844-51. doi: 10.1002/mds.23583. Epub 2011 Mar 2.
PubMed 21370271Fasano A, Schlenstedt C, Herzog J, Plotnik M, Rose FEM, Volkmann J, Deuschl G. Split-belt locomotion in Parkinson's disease links asymmetry, dyscoordination and sequence effect. Gait Posture. 2016 Jul;48:6-12. doi: 10.1016/j.gaitpost.2016.04.020. Epub 2016 Apr 27.
PubMed 27477701Giladi N, Kao R, Fahn S. Freezing phenomenon in patients with parkinsonian syndromes. Mov Disord. 1997 May;12(3):302-5. doi: 10.1002/mds.870120307.
PubMed 9159723Giladi N, Treves TA, Simon ES, Shabtai H, Orlov Y, Kandinov B, Paleacu D, Korczyn AD. Freezing of gait in patients with advanced Parkinson's disease. J Neural Transm (Vienna). 2001;108(1):53-61. doi: 10.1007/s007020170096.
PubMed 11261746Chee R, Murphy A, Danoudis M, Georgiou-Karistianis N, Iansek R. Gait freezing in Parkinson's disease and the stride length sequence effect interaction. Brain. 2009 Aug;132(Pt 8):2151-60. doi: 10.1093/brain/awp053. Epub 2009 May 11.
PubMed 19433440Plotnik M, Giladi N, Balash Y, Peretz C, Hausdorff JM. Is freezing of gait in Parkinson's disease related to asymmetric motor function? Ann Neurol. 2005 May;57(5):656-63. doi: 10.1002/ana.20452.
PubMed 15852404Youn J, Okuma Y, Hwang M, Kim D, Cho JW. Falling Direction can Predict the Mechanism of Recurrent Falls in Advanced Parkinson's Disease. Sci Rep. 2017 Jun 20;7(1):3921. doi: 10.1038/s41598-017-04302-7.
PubMed 28634343Giladi N. Medical treatment of freezing of gait. Mov Disord. 2008;23 Suppl 2:S482-8. doi: 10.1002/mds.21914.
PubMed 18668620Sawada M, Wada-Isoe K, Hanajima R, Nakashima K. Clinical features of freezing of gait in Parkinson's disease patients. Brain Behav. 2019 Apr;9(4):e01244. doi: 10.1002/brb3.1244. Epub 2019 Mar 9.
PubMed 30851088Snijders AH, Weerdesteyn V, Hagen YJ, Duysens J, Giladi N, Bloem BR. Obstacle avoidance to elicit freezing of gait during treadmill walking. Mov Disord. 2010 Jan 15;25(1):57-63. doi: 10.1002/mds.22894.
PubMed 19938174Spildooren J, Vercruysse S, Desloovere K, Vandenberghe W, Kerckhofs E, Nieuwboer A. Freezing of gait in Parkinson's disease: the impact of dual-tasking and turning. Mov Disord. 2010 Nov 15;25(15):2563-70. doi: 10.1002/mds.23327.
PubMed 20632376Ginis P, Nackaerts E, Nieuwboer A, Heremans E. Cueing for people with Parkinson's disease with freezing of gait: A narrative review of the state-of-the-art and novel perspectives. Ann Phys Rehabil Med. 2018 Nov;61(6):407-413. doi: 10.1016/j.rehab.2017.08.002. Epub 2017 Sep 7.
PubMed 28890341Lu C, Amundsen Huffmaster SL, Tuite PJ, Vachon JM, MacKinnon CD. Effect of Cue Timing and Modality on Gait Initiation in Parkinson Disease With Freezing of Gait. Arch Phys Med Rehabil. 2017 Jul;98(7):1291-1299.e1. doi: 10.1016/j.apmr.2017.01.009. Epub 2017 Feb 4.
PubMed 28167093Nutt JG, Bloem BR, Giladi N, Hallett M, Horak FB, Nieuwboer A. Freezing of gait: moving forward on a mysterious clinical phenomenon. Lancet Neurol. 2011 Aug;10(8):734-44. doi: 10.1016/S1474-4422(11)70143-0.
PubMed 21777828
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimentally-induced Freezing of Gait in Parkinson's Disease by Modulating Step Length/Asymmetry and Cognitive/Visual Loading
- ClinicalTrials.gov ID
- NCT04799613
- Acronym / sponsor ID
- 19-6049-B
- Conditions
- Parkinson Disease, Freezing of Gait
- Keywords
- Parkinson, freezing, spilt-belt, Dual task, visual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 16 Mar 2021 (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.
Sample Size N= 10 Parkinson's disease patients with self-reported freezing of gait and 10 without self-reported freezing of gait (in total, 20 Parkinson's disease patients)
Accrual Period Single visit for 2 hours
Study Design This is a cross-sectional study with an intervention to provoke freezing of gait using split-belt treadmill in Parkinson's disease patients with a randomized cross-over design.
After baseline evaluation (a), interventions to induce freezing of gait will be performed in a randomized order to avoid a practice/fatigue effect in the following conditions using combination of 4 interventions: walking speed (fast walking vs. natural walking), visual loading (passing through narrow pathway), cognitive loading (dual task), and asymmetry (best side reduction).
- Natural and fast walking with self-paced mode to access gait parameters and decide the speed for evaluation (3 mins X2) remaining assessment will be randomized and performed on the treadmill:
- Natural and fast walking passing through narrow pathway (2 mins X2)
- Natural and fast walking with dual task (2 mins X2)
- Natural and fast walking passing through narrow pathway and during cognitive dual task (2 mins X2)
- Natural and fast walking reducing the best side (2 mins X2)
- Natural and fast walking reducing the best side passing through narrow pathway (2 mins X2)
- Natural and fast walking reducing the best side with cognitive dual task (2 mins X2)
- Natural and fast walking reducing the best side passing through narrow pathway and during cognitive dual task (2 mins X2)
- Conditions b-h will be carried out on a split-belt treadmill (Grail systems®, by Motek, Netherlands).
- (b-i) freezing of gait episodes will be identified with synchronized videorecordings (screening done by two independent observers). Episodes identified by both observers will be confirmed and measured by comparing the relative height of metatarsal and heel markers of each foot, in keeping with a previous study evaluating freezing of gait episode on a treadmill.
Study Duration
- (Baselines evaluation) Enrolment and assessment (Montreal cognitive assessment, Movement Disorders Society-unified Parkinson's disease rating scale part 2, 3 and 4, Activities-Specific Balance Confidence Scale, Parkinson's disease questionnaire-39, and New freezing of gait questionnaire)
- (a) Formal gait analysis using split-belt treadmill (Grail systems®, by Motek, Netherlands) will be done for baseline assessment (normal walking) and to test patient's ability for fast walking (25% of the normal speed).
- (b-h) Provocation of freezing of gait at split-belt treadmill (Grail systems®, by Motek, Netherlands) with natural and fast walking with/without additional loading or interventions on the asymmetry
Total time= 2 hours
Study Intervention Freezing of gait will be provoked based on the situations combined among 4 conditions; (1) interventions on asymmetry, (2) cognitive dual task, (3) visual loading - passing through narrow pathway, and (4) walking speed at a split-belt treadmill.
- Fast walking will be defined as walking 25% faster than the normal comfortable walking. Subjects who cannot reach this speed, will be asked to walk at their safest maximum speed.
- Passing narrow pathway will be done by walking in a "rope bridge" scene in virtual reality (VR).
- Dual cognitive task will be carried out with serial subtraction prompted on the screen in VR.
- Best side reduction will be defined as 25% slower speed on the best side based on the speed during the initial natural walking with tied configuration setting based on a previous study.3
- Condition b-h will be randomized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Natural walking | No intervention | – |
| fast walking | Experimental | Other: walking speed |
| normal walking passing through narrow pathway | Experimental | Other: visual loading |
| fast walking passing through narrow pathway | Experimental | Other: walking speed, Other: visual loading |
| Natural walking with dual task | Experimental | Other: dual task |
| fast walking with dual task | Experimental | Other: walking speed, Other: dual task |
| Natural walking passing through narrow pathway and during cognitive dual task | Experimental | Other: visual loading, Other: dual task |
| fast walking passing through narrow pathway and during cognitive dual task | Experimental | Other: walking speed, Other: visual loading, Other: dual task |
| Natural walking reducing the best side | Experimental | Other: best side reduction |
| fast walking reducing the best side | Experimental | Other: walking speed, Other: best side reduction |
| Natural walking reducing the best side passing through narrow pathway | Experimental | Other: visual loading, Other: best side reduction |
| fast walking reducing the best side passing through narrow pathway | Experimental | Other: walking speed, Other: visual loading, Other: best side reduction |
| Natural walking reducing the best side with cognitive dual task | Experimental | Other: dual task, Other: best side reduction |
| fast walking reducing the best side with cognitive dual task | Experimental | Other: walking speed, Other: dual task, Other: best side reduction |
| Natural walking reducing the best side passing through narrow pathway and during cognitive dual task | Experimental | Other: visual loading, Other: dual task, Other: best side reduction |
| fast walking reducing the best side passing through narrow pathway and during cognitive dual task | Experimental | Other: walking speed, Other: visual loading, Other: dual task, Other: best side reduction |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Idiopathic Parkinson's disease
- Hoehn \& Yahr Stage 1-3
- Ten with self-reported freezing of gait (score of 1 in part 1 of new freezing of gait questionnaire), and 10 without FOG..
- Sequence effect on feet (as score of at least 2 in the leg agility (item#3.8) of Movement Disorders Society-Unified Parkinson's disease rating scale part 3)
- Stable clinical response to medications or stimulation parameters for at least 1 months
Key exclusion criteria (7 listed)
- Severe imbalance that limits ambulation (Hoehn \&Yahr score above 4)
- Orthostatic hypotension
- Orthopedic conditions and other systemic disease affecting locomotion
- Shortness of breath and cardiac disease
- Psychiatric disorders needing medication
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 |
|---|---|---|
| walking speedwalking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed | Other | fast walking, fast walking passing through narrow pathway, fast walking passing through narrow pathway and during cognitive dual task, fast walking reducing the best side, fast walking reducing the best side passing through narrow pathway, fast walking reducing the best side passing through narrow pathway and during cognitive dual task, fast walking reducing the best side with cognitive dual task, fast walking with dual task |
| visual loadingvisual loading (walking through narrow pathway using VR) | Other | Natural walking passing through narrow pathway and during cognitive dual task, Natural walking reducing the best side passing through narrow pathway, Natural walking reducing the best side passing through narrow pathway and during cognitive dual task, fast walking passing through narrow pathway, fast walking passing through narrow pathway and during cognitive dual task, fast walking reducing the best side passing through narrow pathway, fast walking reducing the best side passing through narrow pathway and during cognitive dual task, normal walking passing through narrow pathway |
| dual taskdual task (serial subtraction using VR) | Other | Natural walking passing through narrow pathway and during cognitive dual task, Natural walking reducing the best side passing through narrow pathway and during cognitive dual task, Natural walking reducing the best side with cognitive dual task, Natural walking with dual task, fast walking passing through narrow pathway and during cognitive dual task, fast walking reducing the best side passing through narrow pathway and during cognitive dual task, fast walking reducing the best side with cognitive dual task, fast walking with dual task |
| best side reductionbest side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side) | Other | Natural walking reducing the best side, Natural walking reducing the best side passing through narrow pathway, Natural walking reducing the best side passing through narrow pathway and during cognitive dual task, Natural walking reducing the best side with cognitive dual task, fast walking reducing the best side, fast walking reducing the best side passing through narrow pathway, fast walking reducing the best side passing through narrow pathway and during cognitive dual task, fast walking reducing the best side with cognitive dual task |
Primary outcome
number of freezing of gait
Time frame: Within intervention (2mins for each situation)
provoked freezing of gait during each situation
2 secondary outcomes
Correlation with Montreal cognitive assessment, Movement Disorders Society-unified Parkinson's disease rating scale part 2 and 3, Activities-Specific Balance Confidence Scale, Parkinson's disease questionnaire-39, and New freezing of gait questionnaire
Time frame: Within intervention (2mins for each situation)
Comparison of number/duration of provoked freezing of gait among the situations between Parkinson's disease patients with and without freezing of gait
Time frame: Within intervention (2mins for each situation)
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 18 Jul 2024.
- Background: PubMed 19660949Nieuwboer A, Rochester L, Herman T, Vandenberghe W, Emil GE, Thomaes T, Giladi N. Reliability of the new freezing of gait questionnaire: agreement between patients with Parkinson's disease and their carers. Gait Posture. 2009 Nov;30(4):459-63. doi: 10.1016/j.gaitpost.2009.07.108. Epub 2009 Aug 5.
- Background: PubMed 21370271Fasano A, Herzog J, Seifert E, Stolze H, Falk D, Reese R, Volkmann J, Deuschl G. Modulation of gait coordination by subthalamic stimulation improves freezing of gait. Mov Disord. 2011 Apr;26(5):844-51. doi: 10.1002/mds.23583. Epub 2011 Mar 2.
- Background: PubMed 27477701Fasano A, Schlenstedt C, Herzog J, Plotnik M, Rose FEM, Volkmann J, Deuschl G. Split-belt locomotion in Parkinson's disease links asymmetry, dyscoordination and sequence effect. Gait Posture. 2016 Jul;48:6-12. doi: 10.1016/j.gaitpost.2016.04.020. Epub 2016 Apr 27.
- Background: PubMed 9159723Giladi N, Kao R, Fahn S. Freezing phenomenon in patients with parkinsonian syndromes. Mov Disord. 1997 May;12(3):302-5. doi: 10.1002/mds.870120307.
- Background: PubMed 11261746Giladi N, Treves TA, Simon ES, Shabtai H, Orlov Y, Kandinov B, Paleacu D, Korczyn AD. Freezing of gait in patients with advanced Parkinson's disease. J Neural Transm (Vienna). 2001;108(1):53-61. doi: 10.1007/s007020170096.
- Background: PubMed 19433440Chee R, Murphy A, Danoudis M, Georgiou-Karistianis N, Iansek R. Gait freezing in Parkinson's disease and the stride length sequence effect interaction. Brain. 2009 Aug;132(Pt 8):2151-60. doi: 10.1093/brain/awp053. Epub 2009 May 11.
- Background: PubMed 15852404Plotnik M, Giladi N, Balash Y, Peretz C, Hausdorff JM. Is freezing of gait in Parkinson's disease related to asymmetric motor function? Ann Neurol. 2005 May;57(5):656-63. doi: 10.1002/ana.20452.
- Background: PubMed 28634343Youn J, Okuma Y, Hwang M, Kim D, Cho JW. Falling Direction can Predict the Mechanism of Recurrent Falls in Advanced Parkinson's Disease. Sci Rep. 2017 Jun 20;7(1):3921. doi: 10.1038/s41598-017-04302-7.
- Background: PubMed 18668620Giladi N. Medical treatment of freezing of gait. Mov Disord. 2008;23 Suppl 2:S482-8. doi: 10.1002/mds.21914.
- Background: PubMed 30851088Sawada M, Wada-Isoe K, Hanajima R, Nakashima K. Clinical features of freezing of gait in Parkinson's disease patients. Brain Behav. 2019 Apr;9(4):e01244. doi: 10.1002/brb3.1244. Epub 2019 Mar 9.
- Background: PubMed 19938174Snijders AH, Weerdesteyn V, Hagen YJ, Duysens J, Giladi N, Bloem BR. Obstacle avoidance to elicit freezing of gait during treadmill walking. Mov Disord. 2010 Jan 15;25(1):57-63. doi: 10.1002/mds.22894.
- Background: PubMed 20632376Spildooren J, Vercruysse S, Desloovere K, Vandenberghe W, Kerckhofs E, Nieuwboer A. Freezing of gait in Parkinson's disease: the impact of dual-tasking and turning. Mov Disord. 2010 Nov 15;25(15):2563-70. doi: 10.1002/mds.23327.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking speed, visual loading and dual task in people with Parkinson Disease and Freezing of Gait, run by University of Toronto at 1 site in Canada.
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 7 inclusion and 7 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 18 Jul 2024. 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 Canada. 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?
number of freezing of gait (time frame: Within intervention (2mins for each situation)). 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 NCT04799613, which also lists 32 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 18 Jul 2024.