Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04315285
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2020-03-17
Brief Title:
Optimal Verbal Instruction to Improve Walking for PD
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Determining Optimal Verbal Instruction to Improve Walking Ability in People With Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background One of the most disturbing motor symptoms in Parkinsons 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 α005
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 α005
Detailed Description:
Background One of the most disturbing motor symptoms in Parkinsons 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 Parkinsons Disease Rating Scale 5 times sit to stand test Timed Up and Go test Fatigue Severity Scale Activities-Specific Balance Confidence Scale Parkinsons 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 α005
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 Parkinsons Disease Rating Scale 5 times sit to stand test Timed Up and Go test Fatigue Severity Scale Activities-Specific Balance Confidence Scale Parkinsons 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 α005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None