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

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01427062
• Other study ID #: PD-001
• Status: Unknown status
• Phase: N/A
• First received: August 30, 2011
• Last updated: August 30, 2011
• Start date: March 2009
• Est. completion date: June 2012

Study information

• Verified date: August 2011
• Source: The Hong Kong Polytechnic University
• Contact: Xia SHEN, PHD candidate
• Phone: +85262378126
• Email: 08901970r[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 52
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• control
Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.

Locations

Country	Name	City	State
China	the Hong Kong Polytechnic University	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reaction time of limits of stability test		One year
Primary	one-leg-stance time		one year
Primary	pull test	it reflects the ability of compensatory postural control in patients with Parkinson's disease	one year
Primary	fall rate		previous one year before baseline assessment, each following one month for 3-month of training and 12-month of follow-up
Primary	movement velocity of limit of stability test		one year
Primary	end point excursion of limits of stability test		One year
Secondary	Unified Parkinson`s Disease rating scale- motor examination subscale	it reflects motor impairment of patients with Parkinson's disease	one year
Secondary	Gait velocity		one year
Secondary	Stride length		One year
Secondary	Cadence		One year