Parkinson DiseaseAT-FOGNCT03015714
Aquatic Therapy for Freezing of Gait in Parkinson's Disease Patients
A study testing MIRT and MIRT-AT in people with Parkinson Disease and Gait Disorders, Neurologic, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation treatment. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic, Gait Disorder, Sensorimotor
- What is being tested?
- MIRT and MIRT-AT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PD according to Gelb et al;
- Hoehn \& Yahr (H\&Y) stage 2.5-3;
- Presence of FOG confirmed in the patient assessment prior to participation in the study;
- Stable pharmacological treatment for the last 8 weeks and during the rehabilitation period;
- Mini Mental State Examination (MMSE) ≥ 24;
Who cannot join
- Cardiac, pulmonary, vestibular and orthopedic diseases;
- Urinary incontinence;
- Severe dyskinesias;
- Patients treated with deep brain stimulation;
- Visual deficits;
- Comorbilities other than PD determining reduction of motor autonomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Aquatic Therapy for Parkinson's Disease Patients in the Context of a Multidisciplinary, Intensive Rehabilitation Treatment
Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation treatment.
Read the detailed description
Freezing of gait (FoG) is an often dramatic, disabling episodic gait pattern that is common in Parkinson's disease (PD). FoG highly impairs mobility, causes falls, and reduces quality of life. Given the limited effectiveness of both the dopaminergic therapy and the deep brain stimulation on this symptom, it represents a challenge in the field of rehabilitation. In the last years, some studies described the effectiveness of aquatic therapy on balance dysfunction in patients with PD, correlating it to the safe conditions offered by the aquatic environment and to the physical properties of water. Nevertheless, the issues concerning the feasibility and the effectiveness of aquatic therapy for the treatment of FoG have never been addressed before. The aquatic environment may act on the sensorial peripheral receptors, thus widely stimulating the proprioceptive system. PD patients show an altered processing of the proprioceptive information that could potentially underline FoG. The investigators aim at investigating the effects of aquatic therapy for the treatment of FoG in PD patients undergoing a Multidisciplinary Intensive Rehabilitation Treatment (MIRT), whose effectiveness on several motor and functional parameters has been already demonstrated.
- Being tested
- MIRT, MIRT-AT
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRTOther
MIRT consists of a 4-week rehabilitation program in a hospital setting, which entails four daily sessions of physical therapy for five days and one hour of physical exercise on the sixth day. On the seventh day the patient rests. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with a physical therapist. The second session includes aerobic exercises to improve balance and gait, using different devices: a stabilometric platform with visual cues, a treadmill plus and a cycloergometer. The third session consists of occupational therapy, the fourth one includes one hour of speech therapy.
MIRT-ATOther
Patients in the MIRT-AT group will undergo the land-based therapy described in MIRT plus three sessions per week (Monday, Wednesday, Friday) of aquatic therapy. On days of aquatic therapy the first session of MIRT was not provided. The aquatic therapy program included aerobic exercises and physical activities to improve balance, motor skills, coordination and joints mobility. The water sessions were divided into 3 phases: i) Warm Up Exercises, ii) Central session Training, iii) Cool-down.
| Study group | Role | What they receive |
|---|---|---|
| MIRT | Active comparator | Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT). Receives: Other: MIRT |
| MIRT-AT | Active comparator | Patients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment associated with Aquatic Therapy (MIRT-AT). Receives: Other: MIRT-AT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freezing of Gait Questionnaire (FOGQ)
Assess FoG frequency, disturbances in gait and relationship to clinical features conceptually associated with gait and motor aspects.
Measured: 4 weeks
Secondary outcomes (6)
Unified Parkinson's Disease Rating Scale tot (UPDRS tot)
Clinician-scored monitored patient's global evaluation.
Measured: 4 weeks
Unified Parkinson's Disease Rating Scale Part III (UPDRS III)
UPDRS subpart: clinician-scored monitored patient's motor evaluation
Measured: 4 weeks
Unified Parkinson's Disease Rating Scale Part II (UPDRS II)
UPDRS subart: clinician-scored monitored patient's activitied daily life evaluation
Measured: 4 weeks
Berg Balance Scale (BBS)
Motor-functional test for balance evaluation
Measured: 4 weeks
Timed Up and Go Test (TUG)
Motor-functional test for sit to stand, walking and turning evaluation
Measured: 4 weeks
Six Minutes Walking Test (6MWT)
Motor-functional test for gait endurance
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017
- Study completionJun 2017
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
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Frazzitta, MD, Study director, "Moriggia-Pelascini" Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015714
- Sponsor's protocol ID
- "Moriggia-Pelascini" Hospital
- Acronym
- AT-FOG
- Status last verified
- Dec 2017
- First submitted
- 7 Jan 2017
- Last updated
- 28 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clerici I, Maestri R, Bonetti F, Ortelli P, Volpe D, Ferrazzoli D, Frazzitta G. Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Freezing of Gait in Parkinson Disease: A Randomized Controlled Trial. Phys Ther. 2019 May 1;99(5):591-600. doi: 10.1093/ptj/pzz003.
PubMed 30657995
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aquatic Therapy for Parkinson's Disease Patients in the Context of a Multidisciplinary, Intensive Rehabilitation Treatment
- ClinicalTrials.gov ID
- NCT03015714
- Acronym / sponsor ID
- AT-FOG / "Moriggia-Pelascini" Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Jan 2017 (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.
Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation treatment.
Detailed description
Freezing of gait (FoG) is an often dramatic, disabling episodic gait pattern that is common in Parkinson's disease (PD). FoG highly impairs mobility, causes falls, and reduces quality of life. Given the limited effectiveness of both the dopaminergic therapy and the deep brain stimulation on this symptom, it represents a challenge in the field of rehabilitation. In the last years, some studies described the effectiveness of aquatic therapy on balance dysfunction in patients with PD, correlating it to the safe conditions offered by the aquatic environment and to the physical properties of water. Nevertheless, the issues concerning the feasibility and the effectiveness of aquatic therapy for the treatment of FoG have never been addressed before. The aquatic environment may act on the sensorial peripheral receptors, thus widely stimulating the proprioceptive system. PD patients show an altered processing of the proprioceptive information that could potentially underline FoG. The investigators aim at investigating the effects of aquatic therapy for the treatment of FoG in PD patients undergoing a Multidisciplinary Intensive Rehabilitation Treatment (MIRT), whose effectiveness on several motor and functional parameters has been already demonstrated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIRT | Active comparator | Other: MIRTPatients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment (MIRT). |
| MIRT-AT | Active comparator | Other: MIRT-ATPatients in this group will undergo a 4-week Multidisciplinary Intensive Rehabilitation Treatment associated with Aquatic Therapy (MIRT-AT). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of PD according to Gelb et al;
- Hoehn \& Yahr (H\&Y) stage 2.5-3;
- Presence of FOG confirmed in the patient assessment prior to participation in the study;
- Stable pharmacological treatment for the last 8 weeks and during the rehabilitation period;
- Mini Mental State Examination (MMSE) ≥ 24;
Key exclusion criteria (6 listed)
- Cardiac, pulmonary, vestibular and orthopedic diseases;
- Urinary incontinence;
- Severe dyskinesias;
- Patients treated with deep brain stimulation;
- Visual deficits;
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 |
|---|---|---|
| MIRTMIRT consists of a 4-week rehabilitation program in a hospital setting, which entails four daily sessions of physical therapy for five days and one hour of physical exercise on the sixth day. On the seventh day the patient rests. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with a physical therapist. The second session includes aerobic exercises to improve balance and gait, using different devices: a stabilometric platform with visual cues, a treadmill plus and a cycloergometer. The third session consists of occupational therapy, the fourth one includes one hour of speech therapy. | Other | MIRT |
| MIRT-ATPatients in the MIRT-AT group will undergo the land-based therapy described in MIRT plus three sessions per week (Monday, Wednesday, Friday) of aquatic therapy. On days of aquatic therapy the first session of MIRT was not provided. The aquatic therapy program included aerobic exercises and physical activities to improve balance, motor skills, coordination and joints mobility. The water sessions were divided into 3 phases: i) Warm Up Exercises, ii) Central session Training, iii) Cool-down. | Other | MIRT-AT |
Primary outcome
Freezing of Gait Questionnaire (FOGQ)
Time frame: 4 weeks
Assess FoG frequency, disturbances in gait and relationship to clinical features conceptually associated with gait and motor aspects.
6 secondary outcomes
Unified Parkinson's Disease Rating Scale tot (UPDRS tot)
Time frame: 4 weeks
Unified Parkinson's Disease Rating Scale Part III (UPDRS III)
Time frame: 4 weeks
Unified Parkinson's Disease Rating Scale Part II (UPDRS II)
Time frame: 4 weeks
Berg Balance Scale (BBS)
Time frame: 4 weeks
Timed Up and Go Test (TUG)
Time frame: 4 weeks
Six Minutes Walking Test (6MWT)
Time frame: 4 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 28 Dec 2017.
- Derived from this study: PubMed 30657995Clerici I, Maestri R, Bonetti F, Ortelli P, Volpe D, Ferrazzoli D, Frazzitta G. Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Freezing of Gait in Parkinson Disease: A Randomized Controlled Trial. Phys Ther. 2019 May 1;99(5):591-600. doi: 10.1093/ptj/pzz003.
- 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 study director
"Moriggia-Pelascini" Hospital
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 and MIRT-AT in people with Parkinson Disease and Gait Disorders, Neurologic, 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 5 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 28 Dec 2017. 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?
Freezing of Gait Questionnaire (FOGQ) (time frame: 4 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 NCT03015714, 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 28 Dec 2017.