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出境医 / 临床实验 / Interest of Hydrophysiotherapy Care in Parkinson Disease's Motor and Non-motor Symptoms (THERMAPARK)
Interest of Hydrophysiotherapy Care in Parkinson Disease's Motor and Non-motor Symptoms (THERMAPARK)
Study Description
Brief Summary:
Parkinson Disease (PD) is a neurodegenerative disorder who begin around 55 years old, characterized by brain's backmatter's dopamine neuron destruction, involved in motor control. Diagnosis is made with presence of 3 of 4 disease's cardinal sign: bradykinesia, rigidity, resting tremor, walking troubles. Treatments enhance patient's quality of life, but do not allow to stop disease's evolution, who is specific depending on a lot of factors. For some years, PD's non motor symptoms (NMS) - in particular pain, anxiety, depression, sleep disorders - have been highlighted and turn out to impair sometimes quality of life even though motor symptoms are controlled. This project's main aim is to evaluate if aquatic environment's care lead to an advantage on PD's NMS, symptoms currently underestimated, insufficiently in care and having a harmful influence on quality of life. Collaboration of the University Hospital (Neurology Dpt), the Physical Medicine and Rehabilitation Regional Institute, Grand Nancy Thermal, and France Parkinson Association, will allow in this way to offer on PD's NMS, postural control impairments, and walking troubles an alternative or further non-pharmacological therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms | Other: Aquatic rehabilitation Other: Land based physical activities Other: Conventional rehabilitation | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 126 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms |
| Estimated Study Start Date : | July 1, 2019 |
| Estimated Primary Completion Date : | September 30, 2021 |
| Estimated Study Completion Date : | November 30, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Experimental: Aquatic rehabilitation |
Other: Aquatic rehabilitation
Rehabilitation sessions using hydrophysiotherapy will occur in a pool of Grand Nancy Thermal, three times per week during 4 weeks, and each will last 45 min. They will begin with 10 min of warm-up, then 30 min of walking. Sessions will end cool-down during 5 min, which will be a reduction of intensity every 30 sec. Rehabilitation will be carried out by physiotherapist chosen for the study.
Other Name: Hydrophysiotherapy
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| Experimental: Land based physical activities |
Other: Land based physical activities
Rehabilitation sessions on treadmill will occur at Physical Medicine and Rehabilitation Regional Institute (IRR), on the University Hospital's site, three times per week during 4 weeks, and each will last 45 min. They will begin with 10 min of warm-up, then 30 min of walking, where intensity of effort can be modulated by speed and inclination of treadmill. Sessions will end cool-down during 5 min, which will be a reduction of intensity every 30 sec. Rehabilitation will be carried out by physiotherapist chosen for the study.
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| Conventional rehabilitation |
Other: Conventional rehabilitation
Conventional rehabilitation sessions will occur in private practices in which patients receive their habitual care (same physiotherapist). This care will be guided by prescription delivered by the neurologist. This prescription suggests to work on active and passive upper and lower limb stretching, on hip and shoulder dissociation, and balance control management on unstable ground.
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Outcome Measures
Primary Outcome Measures :
- Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducation [ Time Frame: Day 1, day 28 (+7) ]Total score to PDQ 39 (between 0 and 156, a lower score being a better outcome), which evaluates quality of life, before and after reeducation
Secondary Outcome Measures :
- Persistence of change of score on PDQ 39 after reeducation [ Time Frame: Day 28(+7), day 56 (+/-7) ]Total score to Parkinson Disease Questionnaire 39 (between 0 and 156, a lower score being a better outcome), which evaluates quality of life, before and after reeducation.
- PDQ 39 sub-scores [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Sub-score for each of the 8 fields composing PDQ 39: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort
- Non-Motors Signs (NMS) Questionnaire score [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Questionnaire score for NMS (non motor signs) in its globality.
- Parkinson Anxiety Scale (PAS) score [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Parkinson's Anxiety Scale, evaluating anxiety (between 0 and 30, a lower score being a better outcome).
- Parkinson's Disease specific Pain score [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]King's Parkinson's Disease Pain Scale (KPPS, between 0 and 168, a lower score being a better outcome)
- Global Pain score [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Visual Analogic Scale (VAS) (between 0 and 10, a lower score being a better score)
- Mean Equilibrium path length [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Corresponding to the mean path length travelled by displacement of the Centre of Foot Pressure in four conditions (eyes open or closed, firm or foamed support).
- Mean Equilibrium ellipse area [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Corresponding to the mean ellipse area covered by displacement of the Centre of Foot Pressure in four conditions (eyes open or closed, firm or foamed support)
- Ratio of sensory inputs. [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Ratio of sensory inputs in postural control (somatosensory, visual and vestibular ratios).
- Entropy [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Entropy mathematically evaluates the displacements regularity of the Center of Foot Pressure (CoP). If the CoP displacements are regular (lower entropy), intentionally processes are more implicated in postural control regulation. If the CoP displacements are not regular (higher entropy), automatic processes are more implicated in postural control regulation. Entropy comparison between a single and a dual task is analyzed.
- Time for Time Up and Go (TUG) [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Timed Up and Go
- Distance of walking [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Distance walked during the 6 min walk test
- Walking velocity [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Mean velocity during the 6 min walk test.
- Step high [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Mean step high during the 6 min walk test.
- Step length [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Mean step length during the 6 min walk test.
- Step width [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Mean step width during the 6 min walk test.
- Subjective effort [ Time Frame: Day 1, day 28 (+7), day 56 (+/-7) ]Ratio of Perceived Exertion (RPE) score, evaluated by Borg Scale (according to the 6 min walk test). Score is between 6 and 20, 6 being a better outcome.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria, patient:
- having get a complete information on study's organization and having given written informed consent,
- affiliated to a social security system,
- suffering from Parkinson's disease (stage 2 or 3 of Hoehn and Yahr),
- with motor fluctuation lower than 25% of awaked time,
- with dyskinesia lower than 25% of awaked time (according to MDS-UPDRS scale),
- with stable pharmacological treatment during the 30 days before study,
- already benefiting of a physiotherapy.
Exclusion Criteria, patients:
- receiving treatment by apomorphine or Duodopa pump,
- benefiting of brain stimulation,
- taking occasionally benzodiazepine,
- with dementia (MDS-UPDRS 1.1 score > 3),
- having had a sprain on a lower limb joint 3 months or less before the beginning of study,
- having head trauma consequences,
- having vertebrae pain,
- with freezing,
- having skin trouble leading to a contraindication of aquatic activities,
- concerned by L. 1121-5, L. 1121-7 and L 1121-8 articles of French public health code.
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 12, 2019 | ||||
| First Posted Date ICMJE | May 23, 2019 | ||||
| Last Update Posted Date | June 25, 2019 | ||||
| Estimated Study Start Date ICMJE | July 1, 2019 | ||||
| Estimated Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducation [ Time Frame: Day 1, day 28 (+7) ] Total score to PDQ 39 (between 0 and 156, a lower score being a better outcome), which evaluates quality of life, before and after reeducation
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| Original Primary Outcome Measures ICMJE |
Change of score on PDQ 39 after reeducation [ Time Frame: Day 1, day 28 (+7) ] Total score to Parkinson Disease Questionnaire 39 (between 0 and 156, a lower score being a better outcome), which evaluates quality of life, before and after reeducation
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Interest of Hydrophysiotherapy Care in Parkinson Disease's Motor and Non-motor Symptoms | ||||
| Official Title ICMJE | Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms | ||||
| Brief Summary | Parkinson Disease (PD) is a neurodegenerative disorder who begin around 55 years old, characterized by brain's backmatter's dopamine neuron destruction, involved in motor control. Diagnosis is made with presence of 3 of 4 disease's cardinal sign: bradykinesia, rigidity, resting tremor, walking troubles. Treatments enhance patient's quality of life, but do not allow to stop disease's evolution, who is specific depending on a lot of factors. For some years, PD's non motor symptoms (NMS) - in particular pain, anxiety, depression, sleep disorders - have been highlighted and turn out to impair sometimes quality of life even though motor symptoms are controlled. This project's main aim is to evaluate if aquatic environment's care lead to an advantage on PD's NMS, symptoms currently underestimated, insufficiently in care and having a harmful influence on quality of life. Collaboration of the University Hospital (Neurology Dpt), the Physical Medicine and Rehabilitation Regional Institute, Grand Nancy Thermal, and France Parkinson Association, will allow in this way to offer on PD's NMS, postural control impairments, and walking troubles an alternative or further non-pharmacological therapy. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE | Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
126 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | November 30, 2021 | ||||
| Estimated Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria, patient:
Exclusion Criteria, patients:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | |||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03960931 | ||||
| Other Study ID Numbers ICMJE | 2019-A00753-54 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Central Hospital, Nancy, France | ||||
| Study Sponsor ICMJE | Central Hospital, Nancy, France | ||||
| Collaborators ICMJE | Institut Régional de Médecine Physique et de Réadaptation | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Central Hospital, Nancy, France | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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