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

Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo" (Other)
Overall Status
Recruiting
CT.gov ID
NCT05784025
Collaborator
(none)
20
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1
27.1
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Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Gait Training With antiGRAVIty TREadmill 'Alter-G', in Patients With ParkinSON Disease
Actual Study Start Date :
Sep 28, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: AlterG e PD

Device: AlterG e PD
The experimental group of subjects with Parkinson's disease are treated with Alter-G instead of traditional treadmill

Outcome Measures

Primary Outcome Measures

  1. efficacy of AlterG in improving the gait cycle in PD [12 months]

    evaluate the efficacy of the antigravity treadmill Alter-G in improving the gait cycle and gait in patients with Parkinson's disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Definite diagnosis of Parkinson's disease according to the criteria of the "Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease"

  • Evidence of FOG

  • Age between 50 and 85

  • Hoehn Yahr staging between II and III

  • Score at the Mini Mental State Examination ≥ 24 (corrected for age and education) ● Absence of musculoskeletal pathologies;

  • Absence of visual or auditory deficits;

  • Absence of known heart or lung pathologies;

  • Signed informed consent.

Exclusion Criteria:

Diagnosis of Parkinsonisms according to the criteria of the "Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease"

Age ≥ 85 or ≤ 50 years

Score at the Mini Mental State Examination ≤ 24 (corrected for age and education)

Presence of cardiac pacemaker or pharmacological infusion systems by programmable pump systems (Duodopa-gel by J-Peg system)

Presence of cardiac, pulmonary, or musculoskeletal comorbidities that contraindicate physical exercise;

Severe visual and/or hearing impairment;

Failure to sign the informed consent.

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Contacts and Locations

Locations

Site City State Country Postal Code
1 Roberta Cellini Messina Italy 98123

Sponsors and Collaborators

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roberta Cellini, Dott.ssa, IRCCS Centro Neurolesi "Bonino-Pulejo"
ClinicalTrials.gov Identifier:
NCT05784025
Other Study ID Numbers:
  • GRAVITESON
First Posted:
Mar 24, 2023
Last Update Posted:
Mar 24, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2023