Parkinson DiseaseNCT04315285
Optimal Verbal Instruction to Improve Walking for PD
A study testing Treadmill gait training with verbal instruction in people with Parkinson Disease and Gait Disorders, Neurologic, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- Treadmill gait training with verbal instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 May 2020to 15 May 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy, NTU, Taiwan
Taipei
About this study
Official title: Determining Optimal Verbal Instruction to Improve Walking Ability in People With Parkinson's Disease
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.
Read more
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.
Read the detailed description
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.
Group × time repeated measures analysis of variance (ANOVA) will be used to compare the intervention effects. The partial eta square (η2) will be calculated to determine the magnitude of group differences. A significance level will be set at α=0.05.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Being tested
- Treadmill gait training with verbal instruction
- Keywords
- Transcranial magnetic stimulation, Verbal instruction, Focus of attention, Parkinson's disease, Gait training
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill gait training with verbal instructionBehavioural
Each participant will receive 12 treatment with special verbal instruction which depends on participant's group. Each training session will last 60 minutes, including 5 minutes of warm-up stretching exercise, 40 minutes of treadmill training, and 15 minutes of over-ground gait and balance training. Throughout the 40 minutes of treadmill walking, the participants will walk on the level of 0% slope with a body-weight support system (LikorallTM 200, Liko, Sweden) used to protect the participants from falling; no actual weight support of the body will be provided. The frequency of intervention will be 2-3 days a week, spread across 4-6 weeks. The intervention protocols will be the same for all groups except the instruction provided to the participants in each group.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 12 sessions of treadmill training with instruction of 'swing your arms' Receives: Behavioral: Treadmill gait training with verbal instruction |
| Heel-strike group | Experimental | 12 sessions of treadmill training with instruction of 'strike the ground with your heel' Receives: Behavioral: Treadmill gait training with verbal instruction |
| Big step group | Experimental | 12 sessions of treadmill training with instruction of 'lift your foot up high' Receives: Behavioral: Treadmill gait training with verbal instruction |
| Internal focus heel-strike | Experimental | 12 sessions of treadmill training with instruction of 'strike the ground with your heel' Receives: Behavioral: Treadmill gait training with verbal instruction |
| External focus shoe-strike | Experimental | 12 sessions of treadmill training with instruction of 'strike the ground with your shoe-heel' Receives: Behavioral: Treadmill gait training with verbal instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The MoCA will be used to evaluate general cognitive function of the participants. It evaluates several cognitive functions including attention, set-shifting, short-term memory, verbal fluency, calculation, orientation, digit span, conceptual thinking, and visuospatial processing skills. The total score of MoCA is 30 with a higher score indicating better cognitive function. The MoCA has good to excellent psychometric properties
Measured: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
The Stroop Color-Word test
The Stroop Color-Word test will be used to evaluate the changes in executive functions in people with PD. The executive functions involved in the Stroop Color-Word test are selective attention, inhibition, and set-shifting. The Stroop Color-Word test comprises the congruent and incongruent testing conditions. The congruent condition is when the color ink of a word is coherent with the written color name, and the incongruent condition is when the color ink differs from the written color name (e.g., the word 'red' written in blue ink). The participants are instructed to read out the ink color of the word, but not the color word name, as accurately and as fast as possible within 45 seconds.
Measured: 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)
The Unified Parkinson's Disease Rating Scale (UPDRS) is a well-established and widely used rating tool for the evaluation of disease severity of PD. The UPDRS consists of 4 sections: 1) Mentation, Behavior, and Mood, 2) Activities of daily living (ADL), 3) Motor examination, and 4) Complications of therapy. In this proposed study, we will only evaluate Part 3 of the scale - the motor disturbances of the patients. The section of "motor examination" contains 18 tests with 33 items (some tests contain movement of the left and right extremities and/or trunk), and each item scores from 0 (absent of the symptom) to 4 (marked in the symptom and present most of the time). The total score ranges from 0 to 132 for Part 3 of the UPDRS with a lower score indicates less PD symptoms and a higher score suggests more severe in PD disease. Internal consistency and validity has been established to be excellent for UPDRS.
Measured: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Fatigue severity questionnaire (FSS)
The FSS will be used to determine how fatigue interferes an individual's daily living and social participation. It contains 9 items, and each item is scored on a 7-point scale with a score 1 indicates strongly disagree and score 7 indicates strongly agree. The total score ranges from 9 to 63, with a higher score indicate greater fatigue severity.
Measured: 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)
The PDQ-39 is a self-report questionnaire containing 39 items assessing the impact of PD on quality of life. The PDQ-39 covers 8 dimensions: mobility, activities of daily living, emotional well-being, stigma, cognition, communication, and bodily discomfort. The participants are required to answer the questions based on their experiences in the preceding month prior to the interview. The scoring system for each item ranges from 0 (never have difficulty) to 4 (always have difficulty) with lower scores suggesting better quality of life.
Measured: 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)
The NFOG-Q will be used to evaluate the freezing frequency and severity of the patients with PD. It composes of 3 parts; in the first part, a video clip will be shown to the participants with PD and help to classify whether an individual is a freezer or non-freezer. The second and third part of the questionnaire is designed for freezers only. PartⅡassesses the severity of FoG according to the frequency and duration of the freezing episodes, while PartⅢevaluates the impact of freezing on daily activities, such as walking. The reliability and internal consistency of the NFOG-Q have been well-established for patients with PD.
Measured: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Geriatric Depression Scale (GDS)
The GDS is a self-report measure of depression in older adults. The GDS contains 15 items, and the users respond in a "Yes/No" format to each question in reference to the past 1 week.
Measured: 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
The participants will initially sit on a comfortable chair with hips and knees flexed at 90°. Upon a 'GO' signal, the participants will stand up from the chair, walk for 3 meters, turn around, walk back to the chair, and sit down. The participants will be instructed to complete the task at their preferred/ comfortable speed. Good to excellent test-retest reliability and inter-rater reliability have been established in people with PD.
Measured: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Finger sequence task
A finger sequence task will be used to evaluate motor learning ability. The finger sequence task contains 3 numerical sequences, and each sequence is embedded with colored circles and presented on a specific location on the computer screen. The participants will not be informed about the specific sequence-context associations; they will only be instructed to use their index and middle finger of both hands to press the keys for the numerical sequences in a sequential order of 1-2-3-4 as accurately and as fast as possible. The 3 sequences will be presented on the computer screen in a pseudorandom order, and the participants will be required to complete a total of 324 trials (108 trials per sequence) during the acquisition period. Ten minutes and 24 hours after practice, the participants will be tested under different testing conditions.
Measured: 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
The Activities-Specific Balance Confidence (ABC) scale will be used to examine an individual's confidence level of not falling when performing activities of daily living. The ABC Scale contains 16 different activities performed indoors and outdoors. The participants will be asked to rate their confidence level (range from 0% to 100% of confidence) of not falling for each item. An average score of the 16 items (range from 0% to 100%) will be calculated to determine the participant's confidence level of not falling when performing the activities of daily living. The internal consistency and test-retest reliability of the ABC scale in patients with PD were excellent.
Measured: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Corticomotor excitability
Transcranial magnetic stimulation (TMS) will be used to evaluate corticomotor excitability. Corticomotor excitability outcomes will include resting motor threshold (RMT), motor evoke potential (MEP), cortical silent period (CSP) duration, short-interval intracortical inhibition (SICI), intracortical facilitation (ICF), and long-interval intracortical inhibition (LICI). The RMT could reflect the membrane excitability of the corticospinal neurons and the cortical interneurons. Peak-to-peak MEP amplitude is an indicator of the integrity and excitability of the corticospinal tract. The CSP is a period when EMG activity being suppressed for a few hundred milliseconds after the MEP, and has often been used as an indicator of the inhibitory mechanism occurs within the corticospinal tract. The SICI, ICF, and LICI have been identified to be good indicators of intracortical inhibition and facilitation.
Measured: 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
The FTSTS test will be evaluated to represent the strength and endurance of the lower limbs. The participants will be sat on a standardized chair, and they will be required to stand up and then sit down for 5 times as fast as possible. The amount of time the participants need to complete the task will be recorded, and a lesser amount of times would indicate better strength of the lower extremities.
Measured: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start18 May 2020
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Yun Lee, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315285
- Sponsor's protocol ID
- 201912096RIND
- Status last verified
- Jun 2022
- First submitted
- 17 Mar 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li MH, Tai CH, Luh JJ, Chen YJ, Hsu WL, Lee YY. Influence of Verbal Instruction on Gait Training in Parkinson Disease: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2024 Jul 1;103(7):617-623. doi: 10.1097/PHM.0000000000002420. Epub 2024 Jan 6.
PubMed 38207195
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Optimal Verbal Instruction to Improve Walking Ability in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04315285
- Acronym / sponsor ID
- 201912096RIND
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Keywords
- Transcranial magnetic stimulation, Verbal instruction, Focus of attention, Parkinson's disease, Gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 19 Mar 2020 (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.
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.
Detailed description
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.
Group × time repeated measures analysis of variance (ANOVA) will be used to compare the intervention effects. The partial eta square (η2) will be calculated to determine the magnitude of group differences. A significance level will be set at α=0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Treadmill gait training with verbal instruction12 sessions of treadmill training with instruction of 'swing your arms' |
| Heel-strike group | Experimental | Behavioral: Treadmill gait training with verbal instruction12 sessions of treadmill training with instruction of 'strike the ground with your heel' |
| Big step group | Experimental | Behavioral: Treadmill gait training with verbal instruction12 sessions of treadmill training with instruction of 'lift your foot up high' |
| Internal focus heel-strike | Experimental | Behavioral: Treadmill gait training with verbal instruction12 sessions of treadmill training with instruction of 'strike the ground with your heel' |
| External focus shoe-strike | Experimental | Behavioral: Treadmill gait training with verbal instruction12 sessions of treadmill training with instruction of 'strike the ground with your shoe-heel' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Treadmill gait training with verbal instructionEach participant will receive 12 treatment with special verbal instruction which depends on participant's group. Each training session will last 60 minutes, including 5 minutes of warm-up stretching exercise, 40 minutes of treadmill training, and 15 minutes of over-ground gait and balance training. Throughout the 40 minutes of treadmill walking, the participants will walk on the level of 0% slope with a body-weight support system (LikorallTM 200, Liko, Sweden) used to protect the participants from falling; no actual weight support of the body will be provided. The frequency of intervention will be 2-3 days a week, spread across 4-6 weeks. The intervention protocols will be the same for all groups except the instruction provided to the participants in each group. | Behavioural | Big step group, Control group, External focus shoe-strike, Heel-strike group, Internal focus heel-strike |
Primary outcome
Gait performances
Time frame: 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.
12 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
The Stroop Color-Word test
Time frame: 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)
Time frame: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Fatigue severity questionnaire (FSS)
Time frame: 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)
Time frame: 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)
Time frame: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Geriatric Depression Scale (GDS)
Time frame: 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
Time frame: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Finger sequence task
Time frame: 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
Time frame: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
Corticomotor excitability
Time frame: 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
Time frame: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)
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 20 Feb 2024.
- Derived from this study: PubMed 38207195Li MH, Tai CH, Luh JJ, Chen YJ, Hsu WL, Lee YY. Influence of Verbal Instruction on Gait Training in Parkinson Disease: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2024 Jul 1;103(7):617-623. doi: 10.1097/PHM.0000000000002420. Epub 2024 Jan 6.
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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.
Ya-Yun Lee, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill gait training with verbal instruction in people with Parkinson Disease and Gait Disorders, Neurologic, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 performances (time frame: Three time points: pre-test(before intervention), post-test(immediate after intervention), follow-up test(one month after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315285, which also lists 1 linked publication.
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 20 Feb 2024.