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

NCT05784025 | Unknown DMC

• 1 other identifier: GRAVITESON
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• Gait performance

  change in meters at the 6 minute walking test

  12 months

• Gait performance

  change in minutes needed to perform the 10 meter walking test

  12 months

• risk of falls

  incidence of fall episodes

  12 months

Secondary Outcomes (2)

• quality of life

  12 months

• mood

  12 months

Study Arms (2)

AlterG

EXPERIMENTAL

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

Device: AlterG

Control

NO INTERVENTION

Standard rehabilitation program

Interventions

AlterG DEVICE

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

AlterG

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Roberta Cellini

Messina, 98123, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Roberta Cellini, Dr

  IRCCS Centro Neurolesi Bonino Pulejo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Cellini, DR

CONTACT

09060128100; roberta.cellini@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 24, 2023
• Study Start: September 28, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)