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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
AlterG
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Roberta CelliniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AlterG

Control

Arm Description

Traditional rehabilitation program plus robotic rehabilitation making use of the antigravity AlterG device

Standard rehabilitation program

Outcomes

Primary Outcome Measures

Gait performance
change in meters at the 6 minute walking test
Gait performance
change in minutes needed to perform the 10 meter walking test
risk of falls
incidence of fall episodes

Secondary Outcome Measures

quality of life
changes in the EQ-5D (EuroQol five dimensions questionnaire) score
mood
changes in the Hamilton Anxiety Inventory score

Full Information

First Posted
March 14, 2023
Last Updated
April 3, 2023
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT05784025
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AlterG
Arm Type
Experimental
Arm Description
Traditional rehabilitation program plus robotic rehabilitation making use of the antigravity AlterG device
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard rehabilitation program
Intervention Type
Device
Intervention Name(s)
AlterG
Intervention Description
Experimental device reducing weight perception by inducing a no-gravity environment which facilitates the execution of rehabilitation programs
Primary Outcome Measure Information:
Title
Gait performance
Description
change in meters at the 6 minute walking test
Time Frame
12 months
Title
Gait performance
Description
change in minutes needed to perform the 10 meter walking test
Time Frame
12 months
Title
risk of falls
Description
incidence of fall episodes
Time Frame
12 months
Secondary Outcome Measure Information:
Title
quality of life
Description
changes in the EQ-5D (EuroQol five dimensions questionnaire) score
Time Frame
12 months
Title
mood
Description
changes in the Hamilton Anxiety Inventory score
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Cellini, DR
Phone
09060128100
Email
roberta.cellini@irccsme.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta Cellini, Dr
Organizational Affiliation
IRCCS Centro Neurolesi "Bonino-Pulejo"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roberta Cellini
City
Messina
ZIP/Postal Code
98123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Cellini, Dr
Phone
09060128100
Email
roberta.cellini@irccsme.it

12. IPD Sharing Statement

Plan to Share IPD
No

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

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