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

August 30, 2011 updated by: Margaret Kit Yi Mak, The Hong Kong Polytechnic University
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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Recruiting
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xia SHEN, PHD candidate, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ANTICIPATED)

March 1, 2012

Study Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (ESTIMATE)

September 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2011

Last Update Submitted That Met QC Criteria

August 30, 2011

Last Verified

August 1, 2011

More Information

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.

Clinical Trials on Parkinson's Disease

Clinical Trials on experimental

Subscribe