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Parkinson DiseaseNCT04364152

Effects of Attentional Focus Strategy on Dual-task Walking Training in Patients With Parkinson's Disease

A study testing Dual-task walking training in people with Parkinson Disease and Dual-task Walking, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Walking deficits and altered brain capacity have been proved to be two of the main contributing factors in dual-task walking deficits in patients with Parkinson's disease (PD). In the past, patients with PD were usually suggested not to walk in dual-task conditions in order to concentrate on their walking performance… Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Parkinson Disease, Dual-task Walking
What is being tested?
Dual-task walking training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTaiwan
Study dates
6 Aug 2020to 1 Aug 2023
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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • for PD patients:
  • (1) a diagnosis of idiopathic PD by a neurologist expert in movement disorders (2) onset age > 40 years old, (3) presence of gait disorders or freezing of gait (points on 3.10 in MDS-UPDRS>=1 or points on item 3 in NFOG-Q >0) (4) able to walk independently without an assistance device at least for 20 meters (5) without obvious action or postural tremor, according to the score of 3.15 and 3.16 (action and postural tremor of hands) in MDS-UPDRS
  • for healthy elders:
  • (1) without musculoskeletal of neurological diseases which may affect balance or walking performance (2) no medication that might influence their balance or cognition (3) MMSE> 26 points.

Who cannot join

  • for PD patients:
  • (1) with other neurological or musculoskeletal disease that might affect balance or walking (2) have a Mini-Mental State Examination (MMSE) < 27 points (3) have a history of brain surgery (4) have to modulate their medication for duration of the experiment.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • School and Graduate Institute of Physical Therapy, National Taiwan University

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Effects of Attentional Focus Strategy on Dual-task Walking Training in Parkinson's Disease With and Without Freezing of Gait

Walking deficits and altered brain capacity have been proved to be two of the main contributing factors in dual-task walking deficits in patients with Parkinson's disease (PD). In the past, patients with PD were usually suggested not to walk in dual-task conditions in order to concentrate on their walking performance better. However, since dual-task walking is really common in daily-life, this limitation usually lead to a decrease in quality of life for PD patients. In previous studies, effects of using attentional strategies in dual-task walking training remain unclear, while suitable attentional strategies and corresponded neuroplasticity for patients with and without freezing of gait have not been well discussed, either. Accordingly, this study is aimed to identify (1) whether internal or external attentional strategies is more ideal for PD patients with and without freezing of gait in dual-task walking training, and (2) changes in brain activity after receiving dual-task walking training with different attentional strategies in patients with or without freezing of gait. Our hypothesis are (1) patients with or without freezing of gait will react differently in dual-gait training with different attentional strategies, and (2) changes in brain activities will be different according to different attentional strategies given in the training.

Read the detailed description

The hypothesis will be tested by gait performance, suprapostural tasks performance, relative power spectrum of EEG, and scales including MDS-UPDRS, ABC, BBS, and TUG.

Being tested
Dual-task walking training
Keywords
Parkinson, dual-task training, attention, electroencephalogram (EEG)
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual-task walking trainingBehavioural

    Participants will be instructed to perform both motor and cognitive dual-task walking during exercise training. For example, for motor dual-task walking, the participants may be instructed to throw and catch a ball while walking. As for cognitive dual-task walking, the participants may be instructed to name animals or perform calculation while walking.

Study groups in NCT04364152
Study groupRoleWhat they receive
PD patients with freezing of gait, internal strategiesExperimentalParticipants in this group will include PD patients with freezing of gait. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.
Receives: Behavioral: Dual-task walking training
PD patients with freezing of gait, external strategiesExperimentalParticipants in this group will include PD patients with freezing of gait. During dual-task walking training, external attentional strategies will be given, aiming to improve their gait performance.
Receives: Behavioral: Dual-task walking training
PD patients without freezing of gait, internal strategiesExperimentalParticipants in this group will include PD patients without freezing of gait. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.
Receives: Behavioral: Dual-task walking training
PD patients without freezing of gait, external strategiesExperimentalParticipants in this group will include PD patients without freezing of gait. During dual-task walking training, external attentional strategies will be given, aiming to improve their gait performance.
Receives: Behavioral: Dual-task walking training
Healthy elders, internal strategiesExperimentalParticipants in this group will include healthy elders. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.
Receives: Behavioral: Dual-task walking training
Healthy elders, external strategiesExperimentalParticipants in this group will include healthy elders. During dual-task walking training, internal attentional strategies will be given, aiming to improve their gait performance.
Receives: Behavioral: Dual-task walking training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait velocity from GAITRite

    gait performance

    Measured: 60 minutes

  2. Cadence from GAITRite

    gait performance

    Measured: 60 minutes

  3. Mean step length from GAITRite

    gait performance

    Measured: 60 minutes

  4. Step-to-step variability from GAITRite

    gait performance

    Measured: 60 minutes

  5. Amplitude from a triaxial accelerometer, X axes

    motor suprapostural task performance

    Measured: 25 minutes

  6. Amplitude from a triaxial accelerometer, Y axes

    motor suprapostural task performance

    Measured: 25 minutes

  7. Amplitude from a triaxial accelerometer, Z axes

    motor suprapostural task performance

    Measured: 25 minutes

  8. Correct rate on working memory task

    cognitive suprapostural task performance

    Measured: 25 minutes

Secondary outcomes (5)

  1. EEG relative power in the delta band

    brain activity under single, motor dual-task, and cognitive dual-task walking conditions

    Measured: 60 minutes

  2. EEG relative power in the theta band

    brain activity under single, motor dual-task, and cognitive dual-task walking conditions

    Measured: 60 minutes

  3. EEG relative power in the alpha band

    brain activity under single, motor dual-task, and cognitive dual-task walking conditions

    Measured: 60 minutes

  4. EEG relative power in the beta band

    brain activity under single, motor dual-task, and cognitive dual-task walking conditions

    Measured: 60 minutes

  5. EEG relative power in the low gamma band

    brain activity under single, motor dual-task, and cognitive dual-task walking conditions

    Measured: 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2020
  2. Study start6 Aug 2020
  3. Primary completion1 Aug 2021
  4. Study completion1 Aug 2023

Resources

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
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04364152
Sponsor's protocol ID
202001029RIND
Status last verified
Aug 2023
First submitted
23 Apr 2020
Last updated
7 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dual-task walking training in people with Parkinson Disease and Dual-task Walking, 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 4 inclusion and 2 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 7 Sep 2023. 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 velocity from GAITRite (time frame: 60 minutes). The study lists 8 primary outcomes in all. 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 NCT04364152.

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 7 Sep 2023.

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