Freezing in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2023-12-10

Brief Summary

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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.

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Detailed Description

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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

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PDF (Parkinson's Disease with Freezing of Gait)

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

Group Type EXPERIMENTAL

Visual & Auditory Cueing Walker

Intervention Type 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

PDNF (Parkinson's Disease without Freezing of Gait)

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

Group Type EXPERIMENTAL

Visual & Auditory Cueing Walker

Intervention Type 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

Interventions

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Visual & Auditory Cueing Walker

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

Intervention Type OTHER