Effects of Functional Postural Control Training on Functional Performance in People With Parkinson's Disease With Freezing of Gait

NCT05958355 | Unknown

• 1 other identifier: NYCU112071AF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this single-blinded, randomized controlled study aims to establish the effects of functional postural control training on functional performance and FOG in PD individuals with FoG as compared with treadmill training.

Conditions

Parkinson Disease

Keywords

Freezing of gait; Functional postural control training; Functional performance; Parkinson's disease

Outcome Measures

Primary Outcomes (12)

• Functional performance-Time up and go test-speed(m/s)

  Using GaitUp system to evaluate walking speed during the Time Up and Go test.

  Change from baseline time up and go test walking speed and up to 4 weeks (pre- and post-test)

• Functional performance-Time up and go test-cadence (steps/ min)

  Using GaitUp system to evaluate cadence during the Time Up and Go test.

  Change from baseline time up and go test cadence and up to 4 weeks (pre- and post-test)

• Functional performance-Time up and go test-step length (m)

  Using GaitUp system to evaluate step length during the Time Up and Go test.

  Change from baseline time up and go test step length and up to 4 weeks (pre- and post-test)

• Functional performance-dual task Time up and go test-speed(m/s)

  Using GaitUp system to evaluate walking speed during the dual task Time up and go test.

  Change from baseline dual task time up and go test walking speed and up to 4 weeks (pre- and post-test)

• Functional performance-dual task Time up and go test-cadence (steps/ min)

  Using GaitUp system to evaluate cadence during the dual task Time up and go test.

  Change from baseline dual task time up and go test cadence and up to 4 weeks (pre- and post-test)

• Functional performance-dual task Time up and go test-step length (m)

  Using GaitUp system to evaluate step length during the dual task Time up and go test.

  Change from baseline dual task time up and go test step length and up to 4 weeks (pre- and post-test)

• Functional performance-360º turning in place-speed(m/s)

  Using GaitUp system to evaluate speed during the 360º turning in place test.

  Change from baseline 360º turning in place speed and up to 4 weeks (pre- and post-test)

• Functional performance-360º turning in place-cadence (steps/ min)

  Using GaitUp system to evaluate cadence during the 360º turning in place test.

  Change from baseline 360º turning in place cadence and up to 4 weeks (pre- and post-test)

• Functional performance-360º turning in place-step length (m)

  Using GaitUp system to evaluate step length during the 360º turning in place test.

  Change from baseline 360º turning in place step length and up to 4 weeks (pre- and post-test)

• Functional performance-Walking through the door-speed(m/s)

  Using GAITRite® system to evaluate walking speed during walks through the door.

  Change from baseline walking through the door speed and up to 4 weeks (pre- and post-test)

• Functional performance-Walking through the door-cadence (steps/ min)

  Using GAITRite® system to evaluate cadence during walks through the door.

  Change from baseline walking through the door cadence and up to 4 weeks (pre- and post-test)

• Functional performance-Walking through the door-step length (m)

  Using GAITRite® system to evaluate step length during walks through the door.

  Change from baseline walking through the door step length and up to 4 weeks (pre- and post-test)

Secondary Outcomes (1)

• New Freezing of Gait Questionnaire (NFOGQ)

  Change from baseline New Freezing of Gait Questionnaire and up to 4 weeks (pre- and post-test)

Study Arms (2)

Functional postural control training

EXPERIMENTAL

The training includes (1) Maintaining a stationary posture in a standing position for a total of 10 minutes, (2) Posture control training involving unilateral lower limb stepping movements for a total of 10 minutes, and (3) Advanced walking task training, including sudden stops, turns, ball raises, and obstacle crossing during walking, for a total of 10 minutes.

Other: Functional postural control training

Treadmill training

ACTIVE COMPARATOR

The subjects in the control group performed a 30-minute walking session on a treadmill at a self-selected speed.

Other: Treadmill training

Interventions

Functional postural control training OTHER

All participants will receive functional postural control training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions).

Functional postural control training

Treadmill training OTHER

All participants will receive treadmill training for 30 minutes/ session, 3 sessions/ weeks, for 4 weeks (a total of 12 training sessions).

Treadmill training

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hoehn and Yahr stage 2\~4
• Age between 50 to 80 years
• New Freezing of Gait Questionnaire score \> 1
• Able to walk independently for at least 10 meters
• MMSE score ≥24

You may not qualify if:

• Neurological diseases other than PD
• Any cardiovascular, pulmonary, or orthopedic conditions that would impact participation in the study

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ray-Yau Wang, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ray-Yau Wang, PhD

CONTACT

+886-2-2826-7210; rywang@nycu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: August 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

TW (1)