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Rehabilitation in Parkinson Disease Cyclone in Life (IRMA)

Primary Purpose

Parkinson Disease, Physical Disability

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

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hoehn & Yahr between 2.0 and 3.0; No need for a walking aid; Mini-Mental State Examination (MMSE) score >24; Effective dopaminergic pharmacological control; Absence of other relevant neurological comorbidities; Absence of postural deformities (and/or Pisa syndrome); Absence of severe cardiological pathologies (exertional angina, severe decompensation). Ability to travel to the rehabilitation treatment site independently or with support Exclusion Criteria: presence of Deep Brain Stimulation (DBS); presence of severe heart and/or lung disease; presence of therapeutic regimen in the definition phase; impaired joint and/or motor function to follow a proposed rehabilitation treatment programme contraindications to performing MRI scans undergoing rehabilitation therapy in the 3 months preceding enrolment.

Sites / Locations

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control GROUP

irma group

Arm Description

This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, joint range increase with passive and active assisted mobilization sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing positions with feedback and feed-forward techniques. gait training; gait training; proprioceptive exercises and exercises to maintain static and dynamic balance in monopodalica; strengthening of trunk muscles; postural exercises, muscle relaxation/stretching, release of the tracks; re-education in postural passages and transfers with fall prevention strategies.

This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, increasing joint range with assisted passive and active mobilisation sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing with feedback and feed-forward technique. Gait training; gait training; proprioceptive exercises and static and dynamic balance maintenance in monopodalics; trunk muscle strengthening; postural exercises, muscle relaxation/relaxation, caterpillar release; re-education in postural transitions and transfers with fall prevention strategies. Prior to neuromotor rehabilitation treatment, the subjects will undergo rehabilitation training using the NIRVANA augmentative reality system.

Outcomes

Primary Outcome Measures

Berg Balance Scale (BBS)
The Berg Balance Scale is a scale for assessing balance and the risk of falling

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
March 27, 2023
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT05802498
Brief Title
Rehabilitation in Parkinson Disease Cyclone in Life
Acronym
IRMA
Official Title
IR3MA Parkinson Cyclone in Life: Innovation, R3 Rehabilitation - Resonance - RTD Fluxgate Sensor, Multidisciplinary Approach
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison of two rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve: Improved joint function and gait pattern Reduction of the risk of falling or reduction of energy expenditure during physiological gait Evaluation of the increase in maximal effort tolerance · Improved cognitive performances Evaluation of the impact on the quality of life of the patient and family members Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.
Detailed Description
rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve: Improved joint function and gait pattern Reduction of the risk of falling or reduction of energy expenditure during physiological gait Evaluation of the increase in maximal effort tolerance · Improved cognitive performances Evaluation of the impact on the quality of life of the patient and family members Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control GROUP
Arm Type
No Intervention
Arm Description
This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, joint range increase with passive and active assisted mobilization sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing positions with feedback and feed-forward techniques. gait training; gait training; proprioceptive exercises and exercises to maintain static and dynamic balance in monopodalica; strengthening of trunk muscles; postural exercises, muscle relaxation/stretching, release of the tracks; re-education in postural passages and transfers with fall prevention strategies.
Arm Title
irma group
Arm Type
Experimental
Arm Description
This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, increasing joint range with assisted passive and active mobilisation sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing with feedback and feed-forward technique. Gait training; gait training; proprioceptive exercises and static and dynamic balance maintenance in monopodalics; trunk muscle strengthening; postural exercises, muscle relaxation/relaxation, caterpillar release; re-education in postural transitions and transfers with fall prevention strategies. Prior to neuromotor rehabilitation treatment, the subjects will undergo rehabilitation training using the NIRVANA augmentative reality system.
Intervention Type
Device
Intervention Name(s)
IRMA
Intervention Description
For patients in an advanced state of illness, advanced neuromotor rehabilitation treatment included 1) robot therapies, 2) specific water courses (e.g. walking pools, hydrokinesiotherapy pools, etc.), 3) advanced cognitive treatments (e.g. virtual reality courses); 4) augmentative immersive therapy in a virtual environment; 5) courses also dedicated to social reintegration and inclusive activities (theatre-therapy, art-therapy, dance-therapy, agro-therapy, etc.).
Primary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
The Berg Balance Scale is a scale for assessing balance and the risk of falling
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hoehn & Yahr between 2.0 and 3.0; No need for a walking aid; Mini-Mental State Examination (MMSE) score >24; Effective dopaminergic pharmacological control; Absence of other relevant neurological comorbidities; Absence of postural deformities (and/or Pisa syndrome); Absence of severe cardiological pathologies (exertional angina, severe decompensation). Ability to travel to the rehabilitation treatment site independently or with support Exclusion Criteria: presence of Deep Brain Stimulation (DBS); presence of severe heart and/or lung disease; presence of therapeutic regimen in the definition phase; impaired joint and/or motor function to follow a proposed rehabilitation treatment programme contraindications to performing MRI scans undergoing rehabilitation therapy in the 3 months preceding enrolment.
Facility Information:
Facility Name
IRCCS Centro Neurolesi "Bonino-Pulejo"
City
Messina
ZIP/Postal Code
98124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
corresponding author

Learn more about this trial

Rehabilitation in Parkinson Disease Cyclone in Life

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