Parkinson's DiseasePhase 1ParkinsonNCT01301651
Effects of Virtual Reality Training in Patients With Parkinson's Disease
A Phase 1 study testing balance training in people with Parkinson's Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background and Objective: Postural instability is common in patient with Parkinson's disease (PD). The purpose of this study was to investigate the effects of virtual reality (VR) balance training on sensory and cognitive domains of postural control. Setting: Balance Performance Laboratory. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2007to Dec 2008
- Phase
- Phase 1
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopathic Parkinson's disease, (2) intact cognition (Mini-Mental State Examination; MMSE>24), 22 (3) Hoehn and Yahr (H-Y) stage II-III diagnosed by neurologists, (4) not participated in any balance or gait training previously, (5) able to follow simple command and had no uncontrolled chronic condition.-
Who cannot join
- history of other neurological, cardiovascular and orthopedic diseases affecting postural stability, (2) on-off motor fluctuation and dyskinesia above grade 3 by the Unified Parkinson' Disease Scale (UPDRS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Virtual Reality Augmented Balance Training for Postural Control in Patients With Parkinson's Disease
Background and Objective: Postural instability is common in patient with Parkinson's disease (PD). The purpose of this study was to investigate the effects of virtual reality (VR) balance training on sensory and cognitive domains of postural control.
Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and Yahr stage II-III) were recruited and assigned into three groups randomly.
Read more
Intervention: Participants in the virtual reality (VR) group and conventional balance training (CB) group received a 6 weeks balance training program. The control group (CG) did not receive any training.
Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography with single and dual tasks (i.e. with backward subtraction of number) were examined pre-, post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded.
Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at visual and somatosensory conflicting condition) post-training more than CG post-training in either single or dual task. (2) Only CB training significantly increased SOT-5 (i.e., vestibular function without visual conflict) and vestibular sensory ratio (i.e., SOT-5/SOT-1) more than CG post-training in either single or dual task. (3) (3) Neither VR nor CB training reduced VRT significantly under six sensory conditions at post-training and follow-up.
Conclusion: Both VR training and CB training can improve sensory organization for postural control by enhancing utilization of vestibular information, but VR could enhance vestibular function with conflicting proprioceptive and visual information under single and dual tasks in patients with mild to moderate PD.
Read the detailed description
It is common that people who are diagnosed with idiopathic Parkinson disease (PD) experience postural instability during daily activities.Recently, postural instability is suggested as the underlying mechanism of falling in patients with PD. Therefore, how to improve postural stability by balance training is an important issue for these patients.
Basal ganglia have been regarded to be predominantly involved in postural control. Several studies suggested that the dysfunction of basal ganglia in patients with PD might play a major role in postural instability. Furthermore, patients with PD might have impaired utilization of sensory information by the basal ganglia.Computerized dynamic posturography (CDP) has the Sensory Organization Test (SOT), which provides an objective assessment of the main sensory systems (i.e., vision, proprioception and vestibular system) involved in balance and stability. The role of sensory information under six conditions (i.e., eyes open, eyes closed, sway vision, eyes open sway support, eyes closed sway support, and sway vision sway support) has been studied in patients with PD by the SOT of computerized CDP. Their study indicated that patients with PD demonstrated a significant reduction in sensory integration of proprioception and vision, but no significant difference in vestibular function, as compared to age-matched controls. One study showed that patients with PD had visual dependence as an adaptive strategy partly compensating for the impaired proprioception. However, the other study suggested that the cerebellum might be important for sensory integration in patients with PD.
- Conditions
- Parkinson's Disease
- Being tested
- balance training
- Keywords
- Virtual Reality, Balance, Parkinson's disease, Dual Task
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance trainingBehavioural
Also called virtual reality
30 minute each time, 2 times per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality balance training | Experimental | balance board training with virtual reality intervention Receives: Behavioral: balance training |
| conventional balance training | Experimental | physical therapy conventional balance training Receives: Behavioral: balance training |
| control group | No intervention | No physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startNov 2007
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Kwan-Hwa Lin, PhD, Principal investigator, School and Graduate Institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301651
- Sponsor's protocol ID
- 200712039R
- Acronym
- Parkinson
- Status last verified
- Feb 2011
- First submitted
- 18 Feb 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- 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 36602886Yen CY, Lin KH, Hu MH, Wu RM, Lu TW, Lin CH. Effects of virtual reality-augmented balance training on sensory organization and attentional demand for postural control in people with Parkinson disease: a randomized controlled trial. Phys Ther. 2011 Jun;91(6):862-74. doi: 10.2522/ptj.20100050. Epub 2011 Apr 7.
PubMed 21474638
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Augmented Balance Training for Postural Control in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01301651
- Acronym / sponsor ID
- Parkinson / 200712039R
- Conditions
- Parkinson's Disease
- Keywords
- Virtual Reality, Balance, Parkinson's disease, Dual Task
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Nov 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Feb 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.
Background and Objective: Postural instability is common in patient with Parkinson's disease (PD). The purpose of this study was to investigate the effects of virtual reality (VR) balance training on sensory and cognitive domains of postural control.
Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and Yahr stage II-III) were recruited and assigned into three groups randomly.
Intervention: Participants in the virtual reality (VR) group and conventional balance training (CB) group received a 6 weeks balance training program. The control group (CG) did not receive any training.
Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography with single and dual tasks (i.e. with backward subtraction of number) were examined pre-, post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded.
Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at visual and somatosensory conflicting condition) post-training more than CG post-training in either single or dual task. (2) Only CB training significantly increased SOT-5 (i.e., vestibular function without visual conflict) and vestibular sensory ratio (i.e., SOT-5/SOT-1) more than CG post-training in either single or dual task. (3) (3) Neither VR nor CB training reduced VRT significantly under six sensory conditions at post-training and follow-up.
Conclusion: Both VR training and CB training can improve sensory organization for postural control by enhancing utilization of vestibular information, but VR could enhance vestibular function with conflicting proprioceptive and visual information under single and dual tasks in patients with mild to moderate PD.
Detailed description
It is common that people who are diagnosed with idiopathic Parkinson disease (PD) experience postural instability during daily activities.Recently, postural instability is suggested as the underlying mechanism of falling in patients with PD. Therefore, how to improve postural stability by balance training is an important issue for these patients.
Basal ganglia have been regarded to be predominantly involved in postural control. Several studies suggested that the dysfunction of basal ganglia in patients with PD might play a major role in postural instability. Furthermore, patients with PD might have impaired utilization of sensory information by the basal ganglia.Computerized dynamic posturography (CDP) has the Sensory Organization Test (SOT), which provides an objective assessment of the main sensory systems (i.e., vision, proprioception and vestibular system) involved in balance and stability. The role of sensory information under six conditions (i.e., eyes open, eyes closed, sway vision, eyes open sway support, eyes closed sway support, and sway vision sway support) has been studied in patients with PD by the SOT of computerized CDP. Their study indicated that patients with PD demonstrated a significant reduction in sensory integration of proprioception and vision, but no significant difference in vestibular function, as compared to age-matched controls. One study showed that patients with PD had visual dependence as an adaptive strategy partly compensating for the impaired proprioception. However, the other study suggested that the cerebellum might be important for sensory integration in patients with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| virtual reality balance training | Experimental | Behavioral: balance trainingbalance board training with virtual reality intervention |
| conventional balance training | Experimental | Behavioral: balance trainingphysical therapy conventional balance training |
| control group | No intervention | –No physical therapy |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- idiopathic Parkinson's disease, (2) intact cognition (Mini-Mental State Examination; MMSE>24), 22 (3) Hoehn and Yahr (H-Y) stage II-III diagnosed by neurologists, (4) not participated in any balance or gait training previously, (5) able to follow simple command and had no uncontrolled chronic condition.-
Key exclusion criteria (1 listed)
- history of other neurological, cardiovascular and orthopedic diseases affecting postural stability, (2) on-off motor fluctuation and dyskinesia above grade 3 by the Unified Parkinson' Disease Scale (UPDRS)
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 |
|---|---|---|
| balance trainingAlso: virtual reality30 minute each time, 2 times per week for 6 weeks. | Behavioural | conventional balance training, virtual reality balance training |
Primary outcome
The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 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.
- Derived from this study: PubMed 21474638Yen CY, Lin KH, Hu MH, Wu RM, Lu TW, Lin CH. Effects of virtual reality-augmented balance training on sensory organization and attentional demand for postural control in people with Parkinson disease: a randomized controlled trial. Phys Ther. 2011 Jun;91(6):862-74. doi: 10.2522/ptj.20100050. Epub 2011 Apr 7.
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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.
Kwan-Hwa Lin, PhD principal investigator
School and Graduate Institute of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing balance training in people with Parkinson's Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Oct 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 Taiwan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. (time frame: 6 weeks). 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 NCT01301651, which also lists 3 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 17 Oct 2011.