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

April 3, 2023 updated by: Roberta Cellini, IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AlterG
Traditional rehabilitation program plus robotic rehabilitation making use of the antigravity AlterG device
Experimental device reducing weight perception by inducing a no-gravity environment which facilitates the execution of rehabilitation programs
No Intervention: Control
Standard rehabilitation program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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