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

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ClinicalTrials.gov Identifier: NCT01427062
Recruitment Status : Unknown
Verified August 2011 by Margaret Kit Yi Mak, The Hong Kong Polytechnic University.
Recruitment status was:  Recruiting
First Posted : September 1, 2011
Last Update Posted : September 1, 2011
Sponsor:
Information provided by (Responsible Party):
Margaret Kit Yi Mak, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment
Parkinson's Disease Other: experimental Other: control

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2009
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. reaction time of limits of stability test [ Time Frame: One year ]
  2. one-leg-stance time [ Time Frame: one year ]
  3. pull test [ Time Frame: one year ]
    it reflects the ability of compensatory postural control in patients with Parkinson's disease

  4. 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 ]
  5. movement velocity of limit of stability test [ Time Frame: one year ]
  6. end point excursion of limits of stability test [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Unified Parkinson`s Disease rating scale- motor examination subscale [ Time Frame: one year ]
    it reflects motor impairment of patients with Parkinson's disease

  2. Gait velocity [ Time Frame: one year ]
  3. Stride length [ Time Frame: One year ]
  4. Cadence [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: September 1, 2011
Last Verified: August 2011

Keywords provided by Margaret Kit Yi Mak, 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