Clinical trial NCT01427062: Effects of an Innovative Balance Training Programme in Enhancing Postural Control and Reducing Falls in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: parkinson's disease
balance
anticipatory postural adjustment
componsatory postural adjustment
falls
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2011-09-01
Enrollment: 52
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: reaction time of limits of stability test
timeFrame: One year
measure: one-leg-stance time
timeFrame: one year
measure: pull test
timeFrame: one year
measure: fall rate
timeFrame: previous one year before baseline assessment, each following one month for 3-month of training and 12-month of follow-up
measure: movement velocity of limit of stability test
timeFrame: one year
measure: end point excursion of limits of stability test
timeFrame: One year
Secondary outcomes:
measure: Unified Parkinson's Disease rating scale- motor examination subscale
timeFrame: one year
measure: Gait velocity
timeFrame: one year
measure: Stride length
timeFrame: One year
measure: Cadence
timeFrame: One year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: the Hong Kong Polytechnic University
state: Hong Kong
Study officials:
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: Xia SHEN, PHD candidate
role: PRINCIPAL_INVESTIGATOR
References: