Parkinson DiseaseNCT02701621
Aquatic Therapy Versus Land-Based Therapy for the Treatment of Balance Dysfunction in Parkinson's Disease
A study testing MIRT-AT and MIRT in people with Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
The aim of this study is to compare the effectiveness of a specific aquatic therapy program on balance with a land-based physical-treatment in patients with Parkinson's disease and to evaluate the long-term effects in a 6-month follow-up period. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- MIRT-AT and MIRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Dec 2014
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Probable diagnosis of PD according to Gelb et al
- Hoehn \& Yahr stage 2.5-3 (H\&Y),
- Stable pharmacological treatment for the last 8 weeks and during the hospitalization
- Mini-Mental State Examination (MMSE) ≥ 24
Who cannot join
- Cardiac and pulmonary diseases
- Urinary incontinence
- History of deep brain stimulation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
Gravedona Ed Uniti, Como, 22015
About this study
Official title: Aquatic Therapy Versus Land-Based Therapy for the Treatment of Balance Dysfunction in Parkinson's Disease: a Randomized, Controlled Study With 6-months Follow-up
The aim of this study is to compare the effectiveness of a specific aquatic therapy program on balance with a land-based physical-treatment in patients with Parkinson's disease and to evaluate the long-term effects in a 6-month follow-up period.
Read the detailed description
Background: Balance dysfunction (BD) in Parkinson's disease (PD) is a disabling sign leading to falls which have a negative impact on the quality of life. It is known that aquatic therapy could be useful to train balance given its physical features and for reducing patients' fear of falls. Many studies have evaluated the efficacy of land-based physiotherapy in treatment of BD, but few studies have investigated the efficacy of aquatic therapy on balance and none of those assessed clinical measurements in a clinically, relevant follow-up period.
Objective: The aim of study was to compare the effectiveness of a specific aquatic therapy program on balance with a land-based physical-treatment in patients with PD and to evaluate the long-term effects in a 6-month follow-up period.
Methods: Thirty-four patients with PD in medium-stage of disease were randomized into two groups: 17 underwent Multidisciplinary-Intensive-Rehabilitation-Treatment (MIRT) and 17 underwent MIRT associated with aquatic therapy protocol (MIRT-AT). Investigators assessed the Berg Balance Scale (BBS), Unified Parkinson's Disease Rating Scale (UPDRS) II-III, and Timed Up Go test (TUG) in both groups at admission, discharge and after a 6-months follow-up period.
- Conditions
- Parkinson Disease
- Being tested
- MIRT-AT, MIRT
- Keywords
- Parkinson's disease, aquatic therapy, balance, MIRT
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRT-ATOther
Aquatic therapy
MIRTOther
Land-based Therapy
| Study group | Role | What they receive |
|---|---|---|
| MIRT Group | Active comparator | Individuals underwent Multidisciplinary Intensive Rehabilitation Treatment. It consists of 4 weeks of physical therapy in a hospital setting with four daily sessions for five days and one hour of physical exercise on the sixth day.The duration of each session is about one hour. The first session comprises cardiovascular warm-up activities, relaxation and muscle-stretching. The second session includes aerobic exercises and the use of different devices: a stabilometric platform, treadmill plus, crossover, cycloergometer. The third is a session of occupational therapy. The last session includes one hour of speech therapy. The rehabilitation program can also include: robotic-assisted walking training, virtual reality training and meetings with a Psychologist. Receives: Other: MIRT |
| MIRT-AT | Experimental | Patients underwent land-based therapy in association with aquatic therapy, three times per week for four weeks.
The land-based activities included the second and the third session of MIRT.
The water sessions were divided in 3 phases:
i) Warm Up Exercises. This phase lasted 10 minutes and comprised walking performances.
ii) Central session Training. This phase lasted 30-45 minutes and comprised trunk mobility exercises in standing position and sitting on a floating device, static and dynamic exercises. The successive balance training exercises comprised: maintaining balance with closed eyes; balance control with one leg resting on a step; postural control changing the support base.
iii) Cool-down. This phase lasted 5 minutes and comprised general stretching exercises and gentle walking. Receives: Other: MIRT-AT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Measured: 6 months
Secondary outcomes (3)
TUG
Measured: 6 months
Unified Parkinson's Disease Rating Scale II
Measured: 6 months
Unified Parkinson's Disease Rating Scale III
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701621
- Sponsor's protocol ID
- ATvsLB Therapy for BD in PD
- Status last verified
- Mar 2016
- First submitted
- 29 Feb 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Palamara G, Gotti F, Maestri R, Bera R, Gargantini R, Bossio F, Zivi I, Volpe D, Ferrazzoli D, Frazzitta G. Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Balance Dysfunction in Parkinson Disease: A Randomized Controlled Study With 6-Month Follow-Up. Arch Phys Med Rehabil. 2017 Jun;98(6):1077-1085. doi: 10.1016/j.apmr.2017.01.025. Epub 2017 Feb 27.
PubMed 28254636
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic Therapy Versus Land-Based Therapy for the Treatment of Balance Dysfunction in Parkinson's Disease: a Randomized, Controlled Study With 6-months Follow-up
- ClinicalTrials.gov ID
- NCT02701621
- Acronym / sponsor ID
- ATvsLB Therapy for BD in PD
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, aquatic therapy, balance, MIRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Mar 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.
The aim of this study is to compare the effectiveness of a specific aquatic therapy program on balance with a land-based physical-treatment in patients with Parkinson's disease and to evaluate the long-term effects in a 6-month follow-up period.
Detailed description
Background: Balance dysfunction (BD) in Parkinson's disease (PD) is a disabling sign leading to falls which have a negative impact on the quality of life. It is known that aquatic therapy could be useful to train balance given its physical features and for reducing patients' fear of falls. Many studies have evaluated the efficacy of land-based physiotherapy in treatment of BD, but few studies have investigated the efficacy of aquatic therapy on balance and none of those assessed clinical measurements in a clinically, relevant follow-up period.
Objective: The aim of study was to compare the effectiveness of a specific aquatic therapy program on balance with a land-based physical-treatment in patients with PD and to evaluate the long-term effects in a 6-month follow-up period.
Methods: Thirty-four patients with PD in medium-stage of disease were randomized into two groups: 17 underwent Multidisciplinary-Intensive-Rehabilitation-Treatment (MIRT) and 17 underwent MIRT associated with aquatic therapy protocol (MIRT-AT). Investigators assessed the Berg Balance Scale (BBS), Unified Parkinson's Disease Rating Scale (UPDRS) II-III, and Timed Up Go test (TUG) in both groups at admission, discharge and after a 6-months follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIRT Group | Active comparator | Other: MIRTIndividuals underwent Multidisciplinary Intensive Rehabilitation Treatment. It consists of 4 weeks of physical therapy in a hospital setting with four daily sessions for five days and one hour of physical exercise on the sixth day.The duration of each session is about one hour. The first session comprises cardiovascular warm-up activities, relaxation and muscle-stretching. The second session includes aerobic exercises and the use of different devices: a stabilometric platform, treadmill plus, crossover, cycloergometer. The third is a session of occupational therapy. The last session includes one hour of speech therapy. The rehabilitation program can also include: robotic-assisted walking training, virtual reality training and meetings with a Psychologist. |
| MIRT-AT | Experimental | Other: MIRT-ATPatients underwent land-based therapy in association with aquatic therapy, three times per week for four weeks. The land-based activities included the second and the third session of MIRT. The water sessions were divided in 3 phases: i) Warm Up Exercises. This phase lasted 10 minutes and comprised walking performances. ii) Central session Training. This phase lasted 30-45 minutes and comprised trunk mobility exercises in standing position and sitting on a floating device, static and dynamic exercises. The successive balance training exercises comprised: maintaining balance with closed eyes; balance control with one leg resting on a step; postural control changing the support base. iii) Cool-down. This phase lasted 5 minutes and comprised general stretching exercises and gentle walking. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Probable diagnosis of PD according to Gelb et al
- Hoehn \& Yahr stage 2.5-3 (H\&Y),
- Stable pharmacological treatment for the last 8 weeks and during the hospitalization
- Mini-Mental State Examination (MMSE) ≥ 24
Key exclusion criteria (3 listed)
- Cardiac and pulmonary diseases
- Urinary incontinence
- History of deep brain stimulation
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 |
|---|---|---|
| MIRT-ATAquatic therapy | Other | MIRT-AT |
| MIRTLand-based Therapy | Other | MIRT Group |
Primary outcome
Berg Balance Scale
Time frame: 6 months
3 secondary outcomes
TUG
Time frame: 6 months
Unified Parkinson's Disease Rating Scale II
Time frame: 6 months
Unified Parkinson's Disease Rating Scale III
Time frame: 6 months
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 8 Mar 2016.
- Derived from this study: PubMed 28254636Palamara G, Gotti F, Maestri R, Bera R, Gargantini R, Bossio F, Zivi I, Volpe D, Ferrazzoli D, Frazzitta G. Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Balance Dysfunction in Parkinson Disease: A Randomized Controlled Study With 6-Month Follow-Up. Arch Phys Med Rehabil. 2017 Jun;98(6):1077-1085. doi: 10.1016/j.apmr.2017.01.025. Epub 2017 Feb 27.
- 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.
Giuseppe Frazzitta, MD principal investigator
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRT-AT and MIRT in people with Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
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 4 inclusion and 3 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 8 Mar 2016. 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 Italy. 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?
Berg Balance Scale (time frame: 6 months). 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 NCT02701621, which also lists 1 linked publication.
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 8 Mar 2016.