Parkinson DiseaseparkinsonNCT07212205
Freezing in Parkinson's Disease
A study testing Visual & Auditory Cueing Walker in people with Parkinson Disease, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of a visual and auditory cueing walker on freezing of gait during walking in patients with Parkinson\'s disease (PDF), compared to Parkinson patients without freezing of gait (PDNF).Sample size was calculated to detect a difference of 0.37 m/sec on mean… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Visual & Auditory Cueing Walker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Jun 2023to 10 Dec 2023
- 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
Inclusion Criteria:Those with a Hoehn-Yahr classification between 2.5 and 4 were included in the study.
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Exclusion Criteria:Patients with secondary parkinsonism, severe systemic diseases, psychiatric illness, cognitive impairment (Mini-Mental State Examination score \<24), hearing and vision loss, musculoskeletal problems, or symptoms suggestive of cerebellar dysfunction were excluded from the study.
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Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Nezahat Keleşoğlu Faculty of Health Sciences
Konya, Meram, 40336
Necmettin Erbakan University
Konya, Meram, 40690
About this study
Official title: The Effect of Visual and Auditory Cueing Walker on Gait in Individuals With Parkinson's Disease Experiencing Freezing of Gait
The aim of this study was to investigate the effects of a visual and auditory cueing walker on freezing of gait during walking in patients with Parkinson\'s disease (PDF), compared to Parkinson patients without freezing of gait (PDNF).Sample size was calculated to detect a difference of 0.37 m/sec on mean velocity, with a deviation of 0.3 m/sec, two-sided 5% significance level, and power of 90%. Considering the expected 10% dropout rate, twelve subjects were included.Researcher R1 determined whether the subject was eligible for inclusion in the trial and researcher R2 carried out the gait analysis. Both examiners were unaware of group allocation. An independent researcher (R3) performed the clinical evaluation before the procedures started. Participants walked back and forth on a 7-meter walking path under two different conditions: without cues and with a walker providing visual and auditory cues. To assess the risk of falls in both groups, the \"Tinetti Balance and Gait Assessment\" was conducted. Additionally, the \"Dynamic Gait Index\" was used to evaluate the ability to adapt walking to varying task demands, and the Timed Up and Go Test (TUGT) was employed to determine walking speed.
Read the detailed description
This study suggests that a walker providing visual and auditory cues may improve daily walking in patients with Parkinson\'s disease with freezing of gait (PDF) and reduce the risk of falls in patients with Parkinson\'s disease without freezing of gait (PDNF) who exhibit hypokinetic gait patterns.
- Conditions
- Parkinson Disease
- Being tested
- Visual & Auditory Cueing Walker
- Keywords
- Auditory and Visual cue, Gait, Parkinson's disease, Walker
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual & Auditory Cueing WalkerOther
Intervention Name:
Visual \& Auditory Cueing Walker
Other Intervention Names (varsa):
Cueing Walker Walker with Visual \& Auditory Cues
Intervention Description:
"Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The 'no cues' condition represents a repeated-measures control within the same arm. Participants were included based on the presence of freezing of gait."
Planned Enrollment: 18
| Study group | Role | What they receive |
|---|---|---|
| PDF (Parkinson's Disease with Freezing of Gait) | Experimental | Intervention Name: Visual \& Auditory Cueing Walker
Description:
"Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The 'no cues' condition represents a repeated-measures control within the same arm. Participants were included based on the presence of freezing of gait."
Planned Enrollment: 18 Receives: Other: Visual & Auditory Cueing Walker |
| PDNF (Parkinson's Disease without Freezing of Gait) | Experimental | Intervention Name: Visual \& Auditory Cueing Walker
Description:
"Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The 'no cues' condition represents a repeated-measures control within the same arm. Participants were included based on the absence of freezing of gait."
Planned Enrollment: 12 Receives: Other: Visual & Auditory Cueing Walker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Adaptation
Dynamic Gait Index: Time taken by the participant to complete the 7-meter walking path under each condition (without cues and with visual \& auditory cueing walker), measured using the Timed Up and Go Test (TUGT).
Measured: Immediately after walking with the visual and auditory cueing walker test was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start10 Jun 2023
- Primary completion10 Oct 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Arm 1: PDF (Parkinson's Disease with Freezing of Gait) Intervention: Visual \& Auditory Cueing Walker Description: Participants were assessed under two within-subject conditions: walking without cues and walking with a visual \& auditory cueing walker. Arm 2: PDNF (Parkinson's Disease without Freezing of Gait) Intervention: Visual \& Auditory Cueing Walker Description: Participants were assessed under two within-subject conditions: walking without cues and walking with a visual \& auditory cueing walker. This is a non-randomized interventional study with two parallel groups (PDF and PDNF). Each participant was assessed under two within-subject conditions: walking without cues and walking with a visual and auditory cueing walker. The two conditions are repeated measures within each arm
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Altuntas Yilmaz, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212205
- Sponsor's protocol ID
- nezahat keleşoğlu
- Other IDs
- Necmettin Erbakan university
- Acronym
- parkinson
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to participant privacy and confidentiality concerns, as well as institutional regulations governing sensitive patient information.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visual and Auditory Cueing Walker on Gait in Individuals With Parkinson's Disease Experiencing Freezing of Gait
- ClinicalTrials.gov ID
- NCT07212205
- Acronym / sponsor ID
- parkinson / nezahat keleşoğlu
- Conditions
- Parkinson Disease
- Keywords
- Auditory and Visual cue, Gait, Parkinson's disease, Walker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 8 Oct 2025 (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.
The aim of this study was to investigate the effects of a visual and auditory cueing walker on freezing of gait during walking in patients with Parkinson\'s disease (PDF), compared to Parkinson patients without freezing of gait (PDNF).Sample size was calculated to detect a difference of 0.37 m/sec on mean velocity, with a deviation of 0.3 m/sec, two-sided 5% significance level, and power of 90%. Considering the expected 10% dropout rate, twelve subjects were included.Researcher R1 determined whether the subject was eligible for inclusion in the trial and researcher R2 carried out the gait analysis. Both examiners were unaware of group allocation. An independent researcher (R3) performed the clinical evaluation before the procedures started. Participants walked back and forth on a 7-meter walking path under two different conditions: without cues and with a walker providing visual and auditory cues. To assess the risk of falls in both groups, the \"Tinetti Balance and Gait Assessment\" was conducted. Additionally, the \"Dynamic Gait Index\" was used to evaluate the ability to adapt walking to varying task demands, and the Timed Up and Go Test (TUGT) was employed to determine walking speed.
Detailed description
This study suggests that a walker providing visual and auditory cues may improve daily walking in patients with Parkinson\'s disease with freezing of gait (PDF) and reduce the risk of falls in patients with Parkinson\'s disease without freezing of gait (PDNF) who exhibit hypokinetic gait patterns.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: PDF (Parkinson's Disease with Freezing of Gait) Intervention: Visual \& Auditory Cueing Walker Description: Participants were assessed under two within-subject conditions: walking without cues and walking with a visual \& auditory cueing walker. Arm 2: PDNF (Parkinson's Disease without Freezing of Gait) Intervention: Visual \& Auditory Cueing Walker Description: Participants were assessed under two within-subject conditions: walking without cues and walking with a visual \& auditory cueing walker. This is a non-randomized interventional study with two parallel groups (PDF and PDNF). Each participant was assessed under two within-subject conditions: walking without cues and walking with a visual and auditory cueing walker. The two conditions are repeated measures within each arm
| Arm | Type | Receives |
|---|---|---|
| PDF (Parkinson's Disease with Freezing of Gait) | Experimental | Other: Visual & Auditory Cueing WalkerIntervention Name: Visual \& Auditory Cueing Walker Description: "Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The 'no cues' condition represents a repeated-measures control within the same arm. Participants were included based on the presence of freezing of gait." Planned Enrollment: 18 |
| PDNF (Parkinson's Disease without Freezing of Gait) | Experimental | Other: Visual & Auditory Cueing WalkerIntervention Name: Visual \& Auditory Cueing Walker Description: "Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The 'no cues' condition represents a repeated-measures control within the same arm. Participants were included based on the absence of freezing of gait." Planned Enrollment: 12 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Visual & Auditory Cueing WalkerIntervention Name: Visual \& Auditory Cueing Walker Other Intervention Names (varsa): Cueing Walker Walker with Visual \& Auditory Cues Intervention Description: "Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The 'no cues' condition represents a repeated-measures control within the same arm. Participants were included based on the presence of freezing of gait." Planned Enrollment: 18 | Other | PDF (Parkinson's Disease with Freezing of Gait), PDNF (Parkinson's Disease without Freezing of Gait) |
Primary outcome
Gait Adaptation
Time frame: Immediately after walking with the visual and auditory cueing walker test was completed
Dynamic Gait Index: Time taken by the participant to complete the 7-meter walking path under each condition (without cues and with visual \& auditory cueing walker), measured using the Timed Up and Go Test (TUGT).
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 8 Oct 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to participant privacy and confidentiality concerns, as well as institutional regulations governing sensitive patient information.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual & Auditory Cueing Walker in people with Parkinson Disease, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Gait Adaptation (time frame: Immediately after walking with the visual and auditory cueing walker test was completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2025.