Brief Summary

Background: One of the most disturbing motor symptoms in Parkinson's disease (PD) is gait disturbance. Clinicians often use various verbal instructions to correct abnormal gait patterns, and the most commonly used instruction is 'lift the foot up and make big steps.' Despite immediate performance improvement, people with PD are reluctant to walk outdoors with this exaggerated walking strategy because it makes them feel embarrassed, unbalanced, and fatigue easily. Since people with PD walk with flat foot, the investigators propose that an instruction emphasizing heel-strike at foot contact may be effective. When delivering verbal instructions, clinicians should also consider the attentional focus of the instruction. Evidence has shown that instructions with external focus of attention (EF) is more beneficial than internal focus of attention (IF) for motor performance and learning. However, most of the gait-related instructions for PD are IF. The investigators thus aim to design a novel EF instruction and determine whether people with PD can benefit more from EF than IF instruction. Objectives: (1) To investigate the effects of verbal instruction emphasizing heel-strike during gait training in people with PD. (2) To further determine whether an instruction with EF will induce greater training benefits than IF. Methods: Two experiments will be conducted in this study. In experiment 1, 60 individuals with PD will be randomized into the heel-strike (HS), big-step (BIG), and control (CON) groups. All participants will receive 12 sessions of gait training with the specific verbal instruction allocated for each group. The participants will be assessed before, immediately after, and 4 weeks after the interventions. The primary outcome will be gait performance, and the secondary outcomes will include measurements of cognitive and behavioral functions. Additionally, transcranial magnetic stimulation will be used to examine the changes of corticomotor excitability associated with the interventions. In the 2nd experiment, 46 individuals with PD will be randomized into the internal focus heel-strike (IF-HS) or external focus shoe-strike (EF-SS) group. Except for the verbal instruction provided to the participants, other intervention and testing procedures will be the same as experiment 1. Group × time repeated measures analysis of variance (ANOVA) will be used to compare the intervention effects among the groups, and a significance level will be set at α=0.05.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline

Completed

Started May 2020

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

12 months study duration

First Submitted

Initial submission to the registry

March 17, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed

2 months until next milestone

Study Start

First participant enrolled

May 18, 2020

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed

Last Updated

February 20, 2024

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

March 17, 2020

Last Update Submit

February 15, 2024

Conditions

Parkinson Disease Gait Disorders, Neurologic

Keywords

Transcranial magnetic stimulationVerbal instructionFocus of attentionParkinson's diseaseGait training

Outcome Measures

Primary Outcomes (1)

Gait performances
The participants will be required to walk along a 5-meter walkway in their comfortable walking speed for 5 trials under single and dual-task walking conditions. The gait performances will be captured by the Physilog®5 system (Gait Up, Renens, Switzerland), which include two inertial sensors with built-in 3D accelerometers and gyroscopes.
Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)

Secondary Outcomes (12)

Montreal Cognitive Assessment (MoCA)
Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
The Stroop Color-Word test
Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
The Unified Parkinson's Disease Rating Scale (UPDRS)
Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Fatigue severity questionnaire (FSS)
Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Parkinson's Disease Questionnaire-39 (PDQ-39)
Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
+7 more secondary outcomes