Gait Training With antiGRAVIty TREadmill 'Alter-G', in Patients With ParkinSON Disease
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ClinicalTrials.gov Identifier: NCT05784025 |
Recruitment Status :
Recruiting
First Posted : March 24, 2023
Last Update Posted : April 6, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | March 14, 2023 | ||||
First Posted Date ICMJE | March 24, 2023 | ||||
Last Update Posted Date | April 6, 2023 | ||||
Actual Study Start Date ICMJE | September 28, 2021 | ||||
Estimated Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
efficacy of AlterG in improving the gait cycle in PD [ Time Frame: 12 months ] evaluate the efficacy of the antigravity treadmill Alter-G in improving the gait cycle and gait in patients with Parkinson's disease
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Gait Training With antiGRAVIty TREadmill 'Alter-G', in Patients With ParkinSON Disease | ||||
Official Title ICMJE | Gait Training With antiGRAVIty TREadmill 'Alter-G', in Patients With ParkinSON Disease | ||||
Brief Summary | Parkinson's disease (PD) is a neurodegenerative disease characterized mainly by motor symptoms, in particular rigidity, akinesia, tremor, which are associated with postural reflex deficits, impaired balance and gait deficit, with consequent significant limitation and impairment not only of functional independence but also of social and community life. Postural instability leads to the appearance of accidental falls due: to the sudden loss of balance which is associated with the impossibility of implementing the right compensatory parachute reflexes; This can lead to serious consequences in these patients, in particular musculoskeletal trauma. In addition, progressive alterations of the gait lead to the phenomenon of freezing or freezing (FOG), in itself the cause of frequent falls. Physiotherapy in PD, including cueing techniques, treadmill training, and cognitive movement strategies, has been shown to improve balance and gait in PD patients. When we talk about subjects affected by PD. Often the painful symptomatology is an obstacle to intensive rehabilitation treatment. The study conducted by José Fidel Baizabal-Carvallo (10-2020) showed that a training program that includes relatively low workloads provided benefits in different aspects of the Freezing of Gait and greater mobility, with a lower incidence of falls and consequently of musculo-articular damaging events. The Alter-G M320 anti-gravity treadmill allows a lifting force to be applied evenly and comfortably to the patient's body. Lightening the body up to 80% of the weight, thanks to the pressure variation inside the air envelope, Alter-G allows patients or athletes to walk and run respecting motor patterns without compromising the biomechanics of eccentric movement. Through precise air pressure control (DAP - Differential Air Pressure) allows to improve aerobic conditioning activities without increasing the risk of stress injury. In addition, compared to traditional rehabilitation in the pool, AlterG allows maximum precision in the alleviation of discharge, being able to vary the load by one percentage point at a time. |
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Detailed Description | Parkinson's disease (PD) is a neurodegenerative disease characterized mainly by motor symptoms, in particular rigidity, akinesia, tremor, which are associated with postural reflex deficits, impaired balance and gait deficit, evident in particular in the onset phase and during the first years of the disease, which are associated in a more advanced stage cognitive and behavioral disorders, with consequent significant limitation and impairment not only of functional independence but also of social and community life. Although drug treatment has significantly modified the natural course of the disease, the gait and balance deficits worsen over time, leading progressively to higher levels of disability. In particular, postural instability leads to the appearance of accidental falls due: to the sudden loss of balance which is associated with the impossibility of implementing the right compensatory parachute reflexes; This can lead to serious consequences in these patients, in particular musculoskeletal trauma, including fractures of the femur, which can compromise not only the quoad valetudinem but also the quoad vitam. In addition, progressive alterations of the gait lead to the phenomenon of freezing or freezing (FOG), in itself the cause of frequent falls. Physiotherapy in PD, including cueing techniques, treadmill training, and cognitive movement strategies, has been shown to improve balance and gait in PD patients. When we talk about subjects affected by PD, with an average age generally over 65 years, we refer to a slice of the population defined as elderly. In the elderly patient all the physical and psychological problems inherent in the disease, starting with the pain phenomenon, acquire a particular significance in relation to the reduced performance status linked to age and other comorbidities, where chronic-degenerative diseases such as osteoarthritis and osteoporosis play a role of significant impact. Often the painful symptomatology is an obstacle to intensive rehabilitation treatment. The study conducted by José Fidel Baizabal-Carvallo (10-2020) showed that a training program that includes relatively low workloads provided benefits in different aspects of the Freezing of Gait and greater mobility, with a lower incidence of falls and consequently of musculo-articular damaging events. The Alter-G M320 anti-gravity treadmill, developed at NASA, allows a lifting force to be applied evenly and comfortably to the patient's body. Lightening the body up to 80% of the weight, thanks to the pressure variation inside the air envelope, Alter-G allows patients or athletes to walk and run respecting motor patterns without compromising the biomechanics of eccentric movement. This tool allows movement to elderly patients, the recovery of motor efficiency following surgery, learn to walk with joint or limb prostheses, carry out a real recovery in the neurological field, rehabilitate patients with injuries to the lower limbs, achieve effective aerobic conditioning, carry out specific conditioning programs. Through precise air pressure control (DAP - Differential Air Pressure) allows to improve aerobic conditioning activities without increasing the risk of stress injury. In addition, compared to traditional rehabilitation in the pool, AlterG allows maximum precision in the alleviation of discharge, being able to vary the load by one percentage point at a time. More specifically, this technology allows:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Parkinson Disease | ||||
Intervention ICMJE | Device: AlterG
Experimental device reducing weight perception by inducing a no-gravity environment which facilitates the execution of rehabilitation programs
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* 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 | Recruiting | ||||
Estimated Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE |
20 | ||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||
Estimated Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Italy | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05784025 | ||||
Other Study ID Numbers ICMJE | GRAVITESON | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Roberta Cellini, IRCCS Centro Neurolesi "Bonino-Pulejo" | ||||
Original Responsible Party | Roberta Cellini, IRCCS Centro Neurolesi "Bonino-Pulejo", Dott.ssa | ||||
Current Study Sponsor ICMJE | IRCCS Centro Neurolesi "Bonino-Pulejo" | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | IRCCS Centro Neurolesi "Bonino-Pulejo" | ||||
Verification Date | April 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |