Parkinson's DiseaseNCT01427062
Effects of an Innovative Balance Training Programme in Enhancing Postural Control and Reducing Falls in Patients With Parkinson's Disease
A study testing experimental in people with Parkinson's Disease, run by The Hong Kong Polytechnic University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Hong Kong Polytechnic University
Hong Kong, Hong Kong
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- experimental, control
- Keywords
- parkinson's disease, balance, anticipatory postural adjustment, componsatory postural adjustment, falls
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentalOther
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.
controlOther
Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.
| Study group | Role | What they receive |
|---|---|---|
| anticipatory and compensatory postural control training | 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. Receives: Other: experimental |
| strength-focused training | Active comparator | Subjects in control group were provided with strength training of leg muscles using machines and during functional activities. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
reaction time of limits of stability test
Measured: One year
one-leg-stance time
Measured: one year
pull test
it reflects the ability of compensatory postural control in patients with Parkinson's disease
Measured: one year
fall rate
Measured: 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
Measured: one year
end point excursion of limits of stability test
Measured: One year
Secondary outcomes (4)
Unified Parkinson's Disease rating scale- motor examination subscale
it reflects motor impairment of patients with Parkinson's disease
Measured: one year
Gait velocity
Measured: one year
Stride length
Measured: One year
Cadence
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startMar 2009
- Primary completionMar 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Kit Yi Mak, The Hong Kong Polytechnic University
- Investigators
- Xia SHEN, PHD candidate, Principal investigator, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427062
- Sponsor's protocol ID
- PD-001
- Status last verified
- Aug 2011
- First submitted
- 30 Aug 2011
- Last updated
- 1 Sep 2011
- Results posted
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Innovative Balance Training Programme in Enhancing Postural Control and Reducing Falls in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01427062
- Acronym / sponsor ID
- PD-001
- Conditions
- Parkinson's Disease
- Keywords
- parkinson's disease, balance, anticipatory postural adjustment, componsatory postural adjustment, falls
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anticipatory and compensatory postural control training | Experimental | Other: experimentalSubjects 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. |
| strength-focused training | Active comparator | Other: controlSubjects in control group were provided with strength training of leg muscles using machines and during functional activities. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimentalSubjects 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. | Other | anticipatory and compensatory postural control training |
| controlSubjects in control group were provided with strength training of leg muscles using machines and during functional activities. | Other | strength-focused training |
Primary outcome
reaction time of limits of stability test
Time frame: One year
one-leg-stance time
Time frame: one year
pull test
Time frame: one year
it reflects the ability of compensatory postural control in patients with Parkinson's disease
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
movement velocity of limit of stability test
Time frame: one year
end point excursion of limits of stability test
Time frame: One year
4 secondary outcomes
Unified Parkinson's Disease rating scale- motor examination subscale
Time frame: one year
Gait velocity
Time frame: one year
Stride length
Time frame: One year
Cadence
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2011.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xia SHEN, PHD candidate principal investigator
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental in people with Parkinson's Disease, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xia SHEN, PHD candidate (+85262378126, 08901970r@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reaction time of limits of stability test (time frame: One year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01427062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2011.