- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01427062
Effects of an Innovative Balance Training Programme in Enhancing Postural Control and Reducing Falls in Patients With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hong Kong
-
Hong Kong, Hong Kong, China
- Recruiting
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
reaction time of limits of stability test
Time Frame: One year
|
One year
|
|
|
one-leg-stance time
Time Frame: one year
|
one year
|
|
|
pull test
Time Frame: one year
|
it reflects the ability of compensatory postural control in patients with Parkinson's disease
|
one year
|
|
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
|
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
Time Frame: one year
|
one year
|
|
|
end point excursion of limits of stability test
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unified Parkinson's Disease rating scale- motor examination subscale
Time Frame: one year
|
it reflects motor impairment of patients with Parkinson's disease
|
one year
|
|
Gait velocity
Time Frame: one year
|
one year
|
|
|
Stride length
Time Frame: One year
|
One year
|
|
|
Cadence
Time Frame: One year
|
One year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xia SHEN, PHD candidate, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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