Parkinson Disease(PD)NCT02656355
Gait Initiation Difficulty and Anticipatory Postural Adjustment (APA) Impairment in People With PD - Evaluation and Training
A study testing Weight shift training and APA feedback and Weight shift training without APA feedback in people with Parkinson Disease(PD), run by Chang Gung University at 1 site in Taiwan.
Trial summary
Gait initiation (GI) difficulty is common in people with Parkinson's disease (PD). Studies showed that the GI difficulty was related to impaired anticipatory postural adjustments (APA). In healthy people, two phases of APA related center of pressure (COP) shifting were observed before GI. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease(PD)
- What is being tested?
- Weight shift training and APA feedback and Weight shift training without APA feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 May 2015to 31 Jan 2019
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson disease.
Who cannot join
- Musculoskeletal injuries on legs.
- Osteoporosis.
- PD subjects:
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
Trial locations and contacts
1 site in 1 country.
About this study
Gait initiation (GI) difficulty is common in people with Parkinson's disease (PD). Studies showed that the GI difficulty was related to impaired anticipatory postural adjustments (APA). In healthy people, two phases of APA related center of pressure (COP) shifting were observed before GI. In people with PD, delay and decrease amplitude of APA or abnormal multiple APAs were observed during GI.
Conventional balance tests record the maximum displacement and/or velocity of Center of pressure (COP). However, these variables could not show the performance of APA. Previous studies suggested that balance and gait initiation were controlled by separate neural circuitries. This could explain why the conventional COP measurement did not correlate to GI very well.
Read more
It is important to develop GI related APA tests and trainings. Researchers found that a perturbation applied before the COP displacement during GI could delay both GI and APA. This indicates that COP displacement has APA components. Our pilot study shows that there is a reverse direction of COP displacement before voluntary COP displacement, suggesting the existence of APA.
This three year project will evaluate the relationship of the APA of voluntary COP displacement and the APA of GI, establish the APA test for PD, and investigate the effect of APA training on GI in people with PD.
In the first year, 20 people without disability will be recruited. The APA before voluntary COP displacement test, APA before GI, and gait performance will be evaluated. In the second year, 15 people with PD and 15 healthy people will be recruited. Subjects will receive GI test, gait test, and APA before voluntary COP displacement test. The relationship between different types of APA will be established for PD and healthy people. In the third year, 30 people with PD will be randomized into APA training group, balance group, and control group. The different training effect will be evaluated especially on GI, gait performance, and freezing of gait.
This project will advance the knowledge of mechanism of GI difficulty. The result of this project can be applied to clinical rehabilitation of people with GI difficulty.
- Conditions
- Parkinson Disease(PD)
- Being tested
- Weight shift training and APA feedback, Weight shift training without APA feedback
- Keywords
- Gait Initiation, Freezing of gait, Balance training, Anticipatory postural adjustments
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight shift training and APA feedbackOther
Also called APA training group
Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.
Weight shift training without APA feedbackOther
Also called Balance training group
Use COP trajectory to train weight shift on force plate.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1:Healthy people | No intervention | To establish baseline and reliability. |
| Stage 2:Healthy people | No intervention | To establish stage 3 training protocol. |
| Stage 2:PD people | No intervention | To establish stage 3 training protocol. |
| Stage 3:PD APA training group | Experimental | Weight shift training and APA feedback. Receives: Other: Weight shift training and APA feedback |
| Stage 3:PD Balance training group | Experimental | Weight shift training without APA feedback. Receives: Other: Weight shift training without APA feedback |
| Stage 3:PD Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameters
Measure of changes in gait parameters by GaitRite and force plate.
Measured: Baseline, 4 weeks and 8 weeks.
Balance parameters
Measure of changes in balance parameters by force plate.
Measured: Baseline, 4 weeks and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start11 May 2015
- Primary completion30 Oct 2018
- Study completion31 Jan 2019
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 Disease(PD)Studies 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
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656355
- Sponsor's protocol ID
- 103-5361B
- Status last verified
- Mar 2024
- First submitted
- 13 Jan 2016
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Initiation Difficulty and Anticipatory Postural Adjustment (APA) Impairment in People With PD - Evaluation and Training
- ClinicalTrials.gov ID
- NCT02656355
- Acronym / sponsor ID
- 103-5361B
- Conditions
- Parkinson Disease(PD)
- Keywords
- Gait Initiation, Freezing of gait, Balance training, Anticipatory postural adjustments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 11 May 2015 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 14 Jan 2016 (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.
Gait initiation (GI) difficulty is common in people with Parkinson's disease (PD). Studies showed that the GI difficulty was related to impaired anticipatory postural adjustments (APA). In healthy people, two phases of APA related center of pressure (COP) shifting were observed before GI. In people with PD, delay and decrease amplitude of APA or abnormal multiple APAs were observed during GI.
Conventional balance tests record the maximum displacement and/or velocity of Center of pressure (COP). However, these variables could not show the performance of APA. Previous studies suggested that balance and gait initiation were controlled by separate neural circuitries. This could explain why the conventional COP measurement did not correlate to GI very well.
It is important to develop GI related APA tests and trainings. Researchers found that a perturbation applied before the COP displacement during GI could delay both GI and APA. This indicates that COP displacement has APA components. Our pilot study shows that there is a reverse direction of COP displacement before voluntary COP displacement, suggesting the existence of APA.
This three year project will evaluate the relationship of the APA of voluntary COP displacement and the APA of GI, establish the APA test for PD, and investigate the effect of APA training on GI in people with PD.
In the first year, 20 people without disability will be recruited. The APA before voluntary COP displacement test, APA before GI, and gait performance will be evaluated. In the second year, 15 people with PD and 15 healthy people will be recruited. Subjects will receive GI test, gait test, and APA before voluntary COP displacement test. The relationship between different types of APA will be established for PD and healthy people. In the third year, 30 people with PD will be randomized into APA training group, balance group, and control group. The different training effect will be evaluated especially on GI, gait performance, and freezing of gait.
This project will advance the knowledge of mechanism of GI difficulty. The result of this project can be applied to clinical rehabilitation of people with GI difficulty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stage 1:Healthy people | No intervention | –To establish baseline and reliability. |
| Stage 2:Healthy people | No intervention | –To establish stage 3 training protocol. |
| Stage 2:PD people | No intervention | –To establish stage 3 training protocol. |
| Stage 3:PD APA training group | Experimental | Other: Weight shift training and APA feedbackWeight shift training and APA feedback. |
| Stage 3:PD Balance training group | Experimental | Other: Weight shift training without APA feedbackWeight shift training without APA feedback. |
| Stage 3:PD Control group | No intervention | –Control group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson disease.
Key exclusion criteria (6 listed)
- Musculoskeletal injuries on legs.
- Osteoporosis.
- Musculoskeletal injuries on legs
- Osteoporosis.
- Any peripheral or central nervous system injury or disease patients.
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 |
|---|---|---|
| Weight shift training and APA feedbackAlso: APA training groupUse COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training. | Other | Stage 3:PD APA training group |
| Weight shift training without APA feedbackAlso: Balance training groupUse COP trajectory to train weight shift on force plate. | Other | Stage 3:PD Balance training group |
Primary outcome
Gait parameters
Time frame: Baseline, 4 weeks and 8 weeks.
Measure of changes in gait parameters by GaitRite and force plate.
Balance parameters
Time frame: Baseline, 4 weeks and 8 weeks.
Measure of changes in balance parameters by force plate.
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 27 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight shift training and APA feedback and Weight shift training without APA feedback in people with Parkinson Disease(PD), run by Chang Gung University 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 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: finished, as of the sponsor's last update on 27 Mar 2024. 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.
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?
Gait parameters (time frame: Baseline, 4 weeks and 8 weeks.). The study lists 2 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 NCT02656355, 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 27 Mar 2024.