Freezing in Parkinson's Disease

NCT07212205 | Completed

• 2 other identifiers: nezahat keleşoğluNecmettin Erbakan university
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Parkinson Disease

Keywords

Auditory and Visual cue; Gait; Parkinson's disease; Walker

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediately after walking with the visual and auditory cueing walker test was completed

Study Arms (2)

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

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

Other: Visual & Auditory Cueing Walker

Interventions

Visual & Auditory Cueing Walker OTHER

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

PDF (Parkinson's Disease with Freezing of Gait); PDNF (Parkinson's Disease without Freezing of Gait)

Eligibility Criteria

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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (2)

Nezahat Keleşoğlu Faculty of Health Sciences

Konya, Meram, 40336, Turkey (Türkiye)

Location

Necmettin Erbakan University

Konya, Meram, 40690, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 8, 2025
• Study Start: June 10, 2023
• Primary Completion: October 10, 2023
• Study Completion: December 10, 2023
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)