Rehabilitation in Parkinson Disease Cyclone in Life

Not Applicable

Completed

• Conditions: Parkinson Disease; Physical Disability
• Interventions: Device: IRMA

• Registration Number: NCT05802498
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-21
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-20
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
irma group	IRMA	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.

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS)	8 weeks	The Berg Balance Scale is a scale for assessing balance and the risk of falling

Trial Locations

Locations (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"; 🇮🇹 Messina, Italy