NCT01427062

Brief Summary

Falling is a complex and most disabling feature for patients with Parkinson's disease (PD). Previous studies suggested that falls in patients with PD are related to postural instability characterized by deficits in anticipatory postural adjustment (APA) for postural orientation in walking and standing and inadequate postural response to perturbation. The present study developed an innovative balance treatment with focus of anticipatory and compensatory postural control and examined its effects on enhancing balance and gait performance and decreasing fall rate in people with PD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 1, 2011

Status Verified

August 1, 2011

Enrollment Period

3 years

First QC Date

August 30, 2011

Last Update Submit

August 30, 2011

Conditions

Keywords

parkinson's diseasebalanceanticipatory postural adjustmentcomponsatory postural adjustmentfalls

Outcome Measures

Primary Outcomes (6)

  • reaction time of limits of stability test

    One year

  • one-leg-stance time

    one year

  • pull test

    it reflects the ability of compensatory postural control in patients with Parkinson's disease

    one year

  • fall rate

    previous one year before baseline assessment, each following one month for 3-month of training and 12-month of follow-up

  • movement velocity of limit of stability test

    one year

  • end point excursion of limits of stability test

    One year

Secondary Outcomes (4)

  • Unified Parkinson's Disease rating scale- motor examination subscale

    one year

  • Gait velocity

    one year

  • Stride length

    One year

  • Cadence

    One year

Study Arms (2)

anticipatory and compensatory postural control training

EXPERIMENTAL

Subjects in the experimental group were trained the speed and amplitude of anticipatory postural adjustment during fall-prone activities and postural response to perturbation during walking. Training was provided with preparatory cues, computerized machines and treadmill.

Other: experimental

strength-focused training

ACTIVE COMPARATOR

Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.

Other: control

Interventions

Subjects in the experimental group were trained the speed and amplitude of anticipatory postural adjustment during fall-prone activities and postural response to perturbation during walking. Training was provided with preparatory cues, computerized machines and treadmill.

anticipatory and compensatory postural control training
controlOTHER

Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.

strength-focused training

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed as parkinson's disease
  • years old or above
  • stable on anti-parkinsonian medications for at least 6 weeks prior to entry into the study, which will remain unchanged for the duration of the study
  • able to walk a 10 meter distance at least 3 times with or without walking aids independently
  • at stage 2 or 3 of the Hoehn and Yahr staging
  • able to provide informed consent

You may not qualify if:

  • neurological conditions other than PD
  • uncompensated cardiovascular disease
  • less than 23 score on the Mini-Mental State examination,
  • History of fracture or recent musculoskeletal disorders in back or lower limbs which would interfere with the balance during exercise and daily activities
  • visual disturbance or vestibular dysfunction limiting locomotion or balance
  • participation in other balance-related training program more than one time per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Hong Kong Polytechnic University

Hong Kong, Hong Kong, China

RECRUITING

Related Publications (2)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Xia SHEN, PHD candidate

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia SHEN, PHD candidate

CONTACT

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
Associate Professor

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 1, 2011

Study Start

March 1, 2009

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

September 1, 2011

Record last verified: 2011-08

Locations