Follow upNCT03193489
Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease
A study testing Follow-up in people with Follow up and Parkinson Disease, run by Somogy Megyei Kaposi Mór Teaching Hospital.
Trial summary
Individualization of exercise is recommended but rarely performed in patients with Parkinson's disease (PD). Unusually High Intensity and Individual Sensor Motor with Visuomotor Mobility Trainer The clinical symptoms, mobility and posture of PD patients. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Follow up, Parkinson Disease, Rehabilitation
- What is being tested?
- Follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2015to 30 Jun 2017
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parkinson's disease
- Hoenh Yahr scale of 2-3
- Instability problem
Who cannot join
- Severe heart problems
- Severe demeanor
- Alcoholism
- Drug problems
About this study
Official title: A High-intensity Multi-component Agility Intervention in Parkinson's Patients: Two-year Follow-up
Individualization of exercise is recommended but rarely performed in patients with Parkinson's disease (PD).
Unusually High Intensity and Individual Sensor Motor with Visuomotor Mobility Trainer The clinical symptoms, mobility and posture of PD patients. After 3 weeks of intensive treatment, treated patients and the control group were subjected to a two-year observation.
Read more
Objectives: The effect of the unusually highly intense and strictly individualized sensomotor and visuomotor agility program was determined for the clinical symptoms, mobility and stability of non-demented PD patients with a two-year follow-up. Detection and comparison of results of patients undergoing biphasic maintenance with the results of intensively treated patients and the control group.
Patients were recalled every 3 months after the first intensive examination and one year after a one-year control. The results of the active group were continuously compared with the results of the passive and control groups, thus determining the effectiveness of our treatment and the deterioration of the other groups in life-quality.
The treated groups will be divided into two. One Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years. The other group does not undergo a special series of exercises after 3 weeks of intensive therapy.
Main outcome measures: Movement disorder Society Unified Parkinson Disease Rating Scale, Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD symptoms.
In group time, repeated measurements of variance analysis were compared to MDS-UPDRS M-EDL, Beck Depression Score, PDQ-39, EQ5D VAS, Schwab \& England Scale for Parkinson's Disease. The TUG test and 12 static posturographic measurements are compared and compared to the healthy group as a standard.
An at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demeted, stage 2-3 PD patient's clinical symptoms, mobility, and postural stability by functionally meaningful margins. As a long-term solution, a follow-up treatment can slow down the progression of clinical symtoms.
- Conditions
- Follow up, Parkinson Disease, Rehabilitation
- Being tested
- Follow-up, Post-treatment control, Control Parkinson group
- Keywords
- Balance, Posturograpy, quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-upOther
Post-treatment controlOther
After 3 weeks of intensive treatment, no special exercises are performed as a control.
Control Parkinson groupOther
No treatment.
| Study group | Role | What they receive |
|---|---|---|
| Exercise therapy | Experimental | Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years. Receives: Other: Follow-up; Other: Post-treatment control; Other: Control Parkinson group |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ5D-5L
Questionnaire
Measured: 0-5 scale (2 year-long, higher point is better)
posturography
body sway, Objective measurement of holding instability
Measured: mm (2 year-long, the smaller the mm the better the result)
Timed up and Go test
Measuring the speed of walking
Measured: sec (2 year-long, the less time you take the test, the better the result )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start11 May 2015
- Primary completion31 May 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follow upStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Principal investigator, Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193489
- Sponsor's protocol ID
- IKEB0013/2015
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A High-intensity Multi-component Agility Intervention in Parkinson's Patients: Two-year Follow-up
- ClinicalTrials.gov ID
- NCT03193489
- Acronym / sponsor ID
- IKEB0013/2015
- Conditions
- Follow up, Parkinson Disease, Rehabilitation
- Keywords
- Balance, Posturograpy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Somogy Megyei Kaposi Mór Teaching HospitalUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 11 May 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 20 Jun 2017 (actual)
- 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.
Individualization of exercise is recommended but rarely performed in patients with Parkinson's disease (PD).
Unusually High Intensity and Individual Sensor Motor with Visuomotor Mobility Trainer The clinical symptoms, mobility and posture of PD patients. After 3 weeks of intensive treatment, treated patients and the control group were subjected to a two-year observation.
Objectives: The effect of the unusually highly intense and strictly individualized sensomotor and visuomotor agility program was determined for the clinical symptoms, mobility and stability of non-demented PD patients with a two-year follow-up. Detection and comparison of results of patients undergoing biphasic maintenance with the results of intensively treated patients and the control group.
Patients were recalled every 3 months after the first intensive examination and one year after a one-year control. The results of the active group were continuously compared with the results of the passive and control groups, thus determining the effectiveness of our treatment and the deterioration of the other groups in life-quality.
The treated groups will be divided into two. One Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years. The other group does not undergo a special series of exercises after 3 weeks of intensive therapy.
Main outcome measures: Movement disorder Society Unified Parkinson Disease Rating Scale, Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD symptoms.
In group time, repeated measurements of variance analysis were compared to MDS-UPDRS M-EDL, Beck Depression Score, PDQ-39, EQ5D VAS, Schwab \& England Scale for Parkinson's Disease. The TUG test and 12 static posturographic measurements are compared and compared to the healthy group as a standard.
An at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demeted, stage 2-3 PD patient's clinical symptoms, mobility, and postural stability by functionally meaningful margins. As a long-term solution, a follow-up treatment can slow down the progression of clinical symtoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy | Experimental | Other: Follow-up, Other: Post-treatment control, Other: Control Parkinson groupParkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease
- Hoenh Yahr scale of 2-3
- Instability problem
Key exclusion criteria (4 listed)
- Severe heart problems
- Severe demeanor
- Alcoholism
- Drug problems
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 |
|---|---|---|
| Follow-up | Other | Exercise therapy |
| Post-treatment controlAfter 3 weeks of intensive treatment, no special exercises are performed as a control. | Other | Exercise therapy |
| Control Parkinson groupNo treatment. | Other | Exercise therapy |
Primary outcome
EQ5D-5L
Time frame: 0-5 scale (2 year-long, higher point is better)
Questionnaire
posturography
Time frame: mm (2 year-long, the smaller the mm the better the result)
body sway, Objective measurement of holding instability
Timed up and Go test
Time frame: sec (2 year-long, the less time you take the test, the better the result )
Measuring the speed of walking
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 1 May 2020.
- Description Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up in people with Follow up and Parkinson Disease, run by Somogy Megyei Kaposi Mór Teaching Hospital.
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 3 inclusion and 4 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
EQ5D-5L (time frame: 0-5 scale (2 year-long, higher point is better)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.