Effects of an Innovative Balance Training Programme in Enhancing Postural Control and Reducing Falls in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
experimental
control
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring parkinson's disease, balance, anticipatory postural adjustment, componsatory postural adjustment, falls
Eligibility Criteria
Inclusion Criteria:
- diagnosed as parkinson's disease
- 45 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
Exclusion Criteria:
- 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
Sites / Locations
- the Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
anticipatory and compensatory postural control training
strength-focused training
Arm Description
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.
Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.
Outcomes
Primary Outcome Measures
reaction time of limits of stability test
one-leg-stance time
pull test
it reflects the ability of compensatory postural control in patients with Parkinson's disease
fall rate
movement velocity of limit of stability test
end point excursion of limits of stability test
Secondary Outcome Measures
Unified Parkinson's Disease rating scale- motor examination subscale
it reflects motor impairment of patients with Parkinson's disease
Gait velocity
Stride length
Cadence
Full Information
NCT ID
NCT01427062
First Posted
August 30, 2011
Last Updated
August 30, 2011
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT01427062
Brief Title
Effects of an Innovative Balance Training Programme in Enhancing Postural Control and Reducing Falls in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
parkinson's disease, balance, anticipatory postural adjustment, componsatory postural adjustment, falls
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anticipatory and compensatory postural control training
Arm Type
Experimental
Arm Description
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.
Arm Title
strength-focused training
Arm Type
Active Comparator
Arm Description
Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.
Intervention Type
Other
Intervention Name(s)
experimental
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.
Primary Outcome Measure Information:
Title
reaction time of limits of stability test
Time Frame
One year
Title
one-leg-stance time
Time Frame
one year
Title
pull test
Description
it reflects the ability of compensatory postural control in patients with Parkinson's disease
Time Frame
one year
Title
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
Title
movement velocity of limit of stability test
Time Frame
one year
Title
end point excursion of limits of stability test
Time Frame
One year
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease rating scale- motor examination subscale
Description
it reflects motor impairment of patients with Parkinson's disease
Time Frame
one year
Title
Gait velocity
Time Frame
one year
Title
Stride length
Time Frame
One year
Title
Cadence
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed as parkinson's disease
45 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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xia SHEN, PHD candidate
Phone
+85262378126
Email
08901970r@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xia SHEN, PHD candidate
Organizational Affiliation
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Hong Kong Polytechnic University
City
Hong Kong
State/Province
Hong Kong
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effects of an Innovative Balance Training Programme in Enhancing Postural Control and Reducing Falls in Patients With Parkinson's Disease
We'll reach out to this number within 24 hrs