Gait Training With antiGRAVIty TREadmill 'Alter-G', in Patients With ParkinSON Disease

• ClinicalTrials.gov Identifier: NCT05784025
• Recruitment Status: Recruiting
• First Posted: March 24, 2023
• Last Update Posted: April 6, 2023
• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Information provided by (Responsible Party): Roberta Cellini, IRCCS Centro Neurolesi "Bonino-Pulejo"

Tracking Information

• First Submitted Date: March 14, 2023
• First Posted Date: March 24, 2023
• Last Update Posted Date: April 6, 2023
• Actual Study Start Date: September 28, 2021
• Estimated Primary Completion Date: September 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 3, 2023)

• Gait performance [ Time Frame: 12 months ]
  change in meters at the 6 minute walking test
• Gait performance [ Time Frame: 12 months ]
  change in minutes needed to perform the 10 meter walking test
• risk of falls [ Time Frame: 12 months ]
  incidence of fall episodes

Original Primary Outcome Measures (submitted: March 14, 2023)

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

Current Secondary Outcome Measures (submitted: April 3, 2023)

• quality of life [ Time Frame: 12 months ]
  changes in the EQ-5D (EuroQol five dimensions questionnaire) score
• mood [ Time Frame: 12 months ]
  changes in the Hamilton Anxiety Inventory score

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Gait Training With antiGRAVIty TREadmill 'Alter-G', in Patients With ParkinSON Disease
• Official Title: 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.

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:

• Recover stress fractures on bone structures subject to functional overload.
• Orthopedic rehabilitation before and after surgery
• Neurological rehabilitation for the recovery of gait control in patients affected by STROKE or comatose states as a result of severe brain injuries, Parkinson's disease, Multiple Sclerosis.
• Facilitate functional recovery of joints in patients undergoing reconstructive surgery in the lower limbs.
• Strengthening training of elderly patients
• Amateur and competitive sports preparation.
• Lose weight without damaging joints.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Parkinson Disease

Intervention

Device: AlterG

Experimental device reducing weight perception by inducing a no-gravity environment which facilitates the execution of rehabilitation programs

Study Arms

• Experimental: AlterG
  Traditional rehabilitation program plus robotic rehabilitation making use of the antigravity AlterG device
  Intervention: Device: AlterG
• No Intervention: Control
  Standard rehabilitation program

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 3, 2023): 40
• Original Estimated Enrollment (submitted: March 14, 2023): 20
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: September 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Clinical diagnosis of Parkinson's disease
• Evidence of freezing of gait
• Age between 50 and 85
• Hoehn Yahr staging between II and III
• Mini Mental State Examination ≥ 24 (corrected for age and education)

Exclusion Criteria:

• Presence of musculoskeletal diseases
• Presence of severe visual and/or hearing impairment
• Presence of known heart or lung diseases contraindicating physical exercise
• Diagnosis of Parkinsonisms
• Presence of implanted cardiac pacemaker or programmable pump systems

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Roberta Cellini, DR; 09060128100; roberta.cellini@irccsme.it

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT05784025
• Other Study ID Numbers: GRAVITESON
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• 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: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Roberta Cellini, Dr; IRCCS Centro Neurolesi "Bonino-Pulejo"

• PRS Account: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Verification Date: April 2023