Determining Optimal Verbal Instruction to Improve Walking Ability in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Gait performances
研究概览
简要总结
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.
详细描述
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. The action of heel-strike could function as a foot rocker and facilitate forward progression of the limb. Heel-strike could also increase the effective limb length and reduce energy cost during walking. Thus, emphasizing heel-strike during gait training may restore near-normal gait pattern and enhance the patients' compliance.
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: The first aim of this study is to investigate the effects of verbal instruction emphasizing heel-strike during gait training in people with PD. The second aim is 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 idiopathic PD will be randomized into the heel-strike (HS), big-step (BIG), and control (CON) groups. All participants will receive 12 sessions of treadmill and over-ground gait training. During training, the participants will be instructed to 'strike the ground with the heel,' 'lift the foot up high,' or 'swing the arms' in the HS, BIG, or CON group, respectively. 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 finger sequence task, Montreal Cognitive Assessment test, Stroop Color-Word test, Unified Parkinson's Disease Rating Scale, 5 times sit to stand test, Timed Up and Go test, Fatigue Severity Scale, Activities-Specific Balance Confidence Scale, Parkinson's Disease Questionnaire-39, New Freezing of Gait Questionnaire and Geriatric Depression Scale. 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. The instruction for the IF-HS group will be 'strike the ground with the heel,' and 'strike the ground with the shoe-heel' for the EF-SS group. The other intervention and testing procedures will be the same as experiment 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researcher(s) who will conduct the outcome assessments will be masked from the group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able to follow instructions to perform the tasks (Mini Mental State Examination ≥ 24)
- •able to read and hear properly without or with aids (e.g., eyeglasses or hearing aids)
- •can walk independently with or without devices
排除标准
- •has other neurological disorders in addition to PD
- •has deep brain stimulation or pacemaker implanted in their body
- •has a family-history of epilepsy
- •has a self-history of seizure
- •has unstable medical conditions
结局指标
主要结局
Gait performances
时间窗: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
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.
次要结局
- Montreal Cognitive Assessment (MoCA)(Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention))
- New Freezing of Gait Questionnaire (NFOG-Q)(Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention))
- Geriatric Depression Scale (GDS)(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))
- Finger sequence task(Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention))
- The Timed Up and Go (TUG) Test(Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention))
- Activities-Specific Balance Confidence (ABC) Scale(Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention))
- Corticomotor excitability(Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention))
- Five Times Sit-to-Stand (FTSTS) Test(Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention))