NCT06355947

Brief Summary

Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important. Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model. Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity. The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test. The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people. The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

March 26, 2024

Last Update Submit

April 9, 2024

Conditions

Keywords

GaitCycling trainingTreadmill trainingDual-task walkingDual-task cycling

Outcome Measures

Primary Outcomes (7)

  • Walking Speed

    The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).

    Baseline, 4 weeks and 8 weeks

  • Step Length

    The linear distance between the two ankles, typically expressed in centimeters(cm).

    Baseline, 4 weeks and 8 weeks

  • Step Time

    The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.

    Baseline, 4 weeks and 8 weeks

  • Power Spectral Density (PSD)

    Quantifies the power of EEG signals within specific frequency bands (e.g., delta, theta, alpha, beta, and gamma) over a period.

    Baseline, 4 weeks and 8 weeks.

  • Task Accuracy

    The percentage of correct responses or actions made by participants in response to walking or cycling tasks.

    Baseline, 4 weeks and 8 weeks.

  • Reaction Time

    The duration between the onset of task start time and the participant's response to it, typically expressed in second (s).

    Baseline, 4 weeks and 8 weeks.

  • Balance Performance

    Measured by the duration the stance can be maintained, typically expressed second.

    Baseline, 4 weeks and 8 weeks

Secondary Outcomes (6)

  • Double Support Time

    Baseline, 4 weeks and 8 weeks

  • Single Support Time

    Baseline, 4 weeks and 8 weeks

  • Swing Time

    Baseline, 4 weeks and 8 weeks

  • Stance Time

    Baseline, 4 weeks and 8 weeks

  • Cadence

    Baseline, 4 weeks and 8 weeks

  • +1 more secondary outcomes

Study Arms (5)

Stage 1:Healthy people

NO INTERVENTION

To establish a baseline and ensure reliability, and to explore the relationship between dual-task gait performance and dual-task cycling

No Intervention: Stage 2:PD people

NO INTERVENTION

To explore the relationship between dual-task gait and dual-task cycling performances in individuals with Parkinson's Disease (PD)

Stage 3:PD cycling training group

EXPERIMENTAL

Cycling training conducted with cognitive tasks

Other: Cognitive cycling training

Stage 3: PD treadmill training group

EXPERIMENTAL

Treadmill training conducted with cognitive tasks

Other: Cognitive treadmill training

Stage 3:PD Control group

NO INTERVENTION

Control group

Interventions

Cycling training conducted with cognitive tasks

Stage 3:PD cycling training group

Treadmill training conducted with cognitive tasks

Stage 3: PD treadmill training group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Musculoskeletal injuries on legs.
  • Osteoporosis.
  • PD subjects:
  • \- Clinical diagnosis of Parkinson disease.
  • Musculoskeletal injuries on legs
  • Osteoporosis.
  • Any peripheral or central nervous system injury or disease patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 10, 2024

Study Start

December 7, 2015

Primary Completion

September 11, 2017

Study Completion

July 31, 2018

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations