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Effects of an Innovative Balance Training Programme in Enhancing Postural Control and Reducing Falls in Patients With Parkinson's Disease

This study is currently recruiting participants.
Verified August 2011 by The Hong Kong Polytechnic University
Sponsor:
Information provided by (Responsible Party):
Margaret Kit Yi Mak, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01427062
First received: August 30, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Parkinson's Disease
 Other: experimental
Other: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • reaction time of limits of stability test [ Time Frame: One year ] [ Designated as safety issue: No ]
  • one-leg-stance time [ Time Frame: one year ] [ Designated as safety issue: No ]
  • pull test [ Time Frame: one year ] [ Designated as safety issue: No ]
    it reflects the ability of compensatory postural control in patients with Parkinson's disease

  • fall rate [ Time Frame: previous one year before baseline assessment, each following one month for 3-month of training and 12-month of follow-up ] [ Designated as safety issue: No ]
  • movement velocity of limit of stability test [ Time Frame: one year ] [ Designated as safety issue: No ]
  • end point excursion of limits of stability test [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unified Parkinson`s Disease rating scale- motor examination subscale [ Time Frame: one year ] [ Designated as safety issue: No ]
    it reflects motor impairment of patients with Parkinson's disease

  • Gait velocity [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Stride length [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Cadence [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: March 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anticipatory and compensatory postural control training
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
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.
Active Comparator: strength-focused training
Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.
 Other: control
Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.

Detailed Description:

Participants: Forty-two eligible subjects with PD were randomly allocated into balance with focus of anticipatory and compensatory postural control (EXP) or control (CON) group with strength-focused training, with 26 subjects in each group.

Methods: Subjects in the EXP group were trained the speed and amplitude of anticipatory postural adjustment during stepping and walking and postural response to perturbation during walking. Subjects In the CON group were trained to improve the strength of lower limb muscles. Treatment period in both groups lasted for 12 weeks, which consisted of 4-week laboratory-based training (phase 1), 4-week home-based exercise (phase 2) and final 4-week laboratory-based training (phase 3). Outcome measures included reaction time(RT), movement velocity (MV) and endpoint excursion (EPE) of limit-of-stability test, one-leg-stance (OLS) time, gait velocity, stride length (SL), cadence, and fall rate. All tests were conducted for 6 time intervals including baseline, after each training phase, at 3-month follow-up and at 12-month follow-up.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosed as parkinson's disease
  2. 45 years old or above
  3. 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
  4. able to walk a 10 meter distance at least 3 times with or without walking aids independently
  5. at stage 2 or 3 of the Hoehn and Yahr staging
  6. able to provide informed consent

Exclusion Criteria:

  1. neurological conditions other than PD
  2. uncompensated cardiovascular disease
  3. less than 23 score on the Mini-Mental State examination,
  4. History of fracture or recent musculoskeletal disorders in back or lower limbs which would interfere with the balance during exercise and daily activities
  5. visual disturbance or vestibular dysfunction limiting locomotion or balance
  6. participation in other balance-related training program more than one time per week
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427062

Contacts
Contact: Xia SHEN, PHD candidate +85262378126 08901970r@polyu.edu.hk

Locations
China, Hong Kong
the Hong Kong Polytechnic University Recruiting
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Xia SHEN, PHD candidate Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Margaret Kit Yi Mak, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01427062     History of Changes
Other Study ID Numbers: PD-001
Study First Received: August 30, 2011
Last Updated: August 30, 2011
Health Authority: Hong Kong:Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Keywords provided by The Hong Kong Polytechnic University:
parkinson's disease
balance
anticipatory postural adjustment
componsatory postural adjustment
falls

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 19, 2013