Rehabilitation of Postural Abnormalities in Parkinson's Disease

NCT03741959 | Unknown DMC

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

Brief Summary

Postural abnormalities (PA) are drug refractory complications in patients with Parkinson's disease (PD) leading to pain, imbalance, gait disorders and fall-related injuries. It ultimately affects the quality of life and the hospitalisation risk. the literature on treatment outcomes is scant. Rehabilitation is the cornerstone in the management of PD patients, especially for drug-refractory complications. However, the current efforts are only partially able to resolve PA in PD. Despite differences in methodologies, the few rehabilitative studies support the benefits of trunk rehabilitation in PD with PA. Priorities for future research include well-design rehabilitation studies on a large population. The early detection and early rehabilitation of PA might avoid fixed irreversible deformities and reduce the complications that can accompany them. It ultimately might improve the quality of life, reduce the risk of fall-related injuries and hospitalisation rate. A single-blind single-blind Randomised Controlled Trial (RCT) will evaluate the effects of trunk rehabilitation on PA severity, function and disability in outpatients with Parkinson Disease and postural abnormalities.

Conditions

Parkinson Disease

Keywords

postural defect

Outcome Measures

Primary Outcomes (1)

• Changes in the degrees of trunk deviation in the sagittal and coronal plane.

  Changes in the degree of trunk deviation in the sagittal and coronal plane will be assessed using a wall goniometer in standing position.

  Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up

Secondary Outcomes (7)

• Changes in Gait speed (cm/sec)

  Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up

• Changes in the Percentage Difference of Sway (PDS)

  Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up

• Changes in the Unified Parkinson's Disease Rating Scale (UPDRS)

  Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up

• Changes in the Parkinson's Disease Questionnaire (PDQ-8)

  Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up

• The number of falls

  Pre-treatment, after 5 weeks, at 1 month-follow-up and 4-month follow-up

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental group will undergo three groups of exercises: 1) active self-correction exercises (20 minutes) defined as the best possible trunk alignment the patient can achieved in the three-dimensional planes; 2) passive and active trunk stabilization exercises (20 minutes) to improve trunk biomechanical constraint and to counteract the evolution of the misalignment; 3) functional tasks (20 minutes) defined as functional exercises to train the automatic response to maintain the best alignment through the broadest possible range of challenging activities (Romano2015).Training will consist of individualized treatment 60 mins/day, 2 days/week, for 5 consecutive weeks.

Procedure: Experimental group

Control

ACTIVE COMPARATOR

The control group will undergo strengthening exercises and gait training as the usual practice in Parkinson Disease. Training will consist of individualized treatment 60 mins/day, 2 days/week, for 5 consecutive weeks (Bartolo et. al., 2010).

Procedure: Control group

Interventions

Experimental group PROCEDURE

Active self-correction exercises (20 minutes) to achieve the best possible trunk alignment the patient can achieve in the three-dimensional planes using visual, proprioceptive and EMG feedbacks. Passive and active trunk stabilization exercises (20 minutes) to improve trunk biomechanical constraint Functional tasks (20 minutes) defined as functional exercises to train the automatic response to maintain the best alignment through the broadest possible range of challenging activities (Romano2015).

Experimental

Control group PROCEDURE

Training consisted of passive and active trunk mobilization (10 minutes) followed by muscle stretching, and strengthening exercises, and gait training (50 minutes)(Bartolo et. al., 2010).

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age higher than 18 years old:
• A medical diagnosis of PD confirmed according to the Movement disorders criteria;
• PS defined as at least 10 degrees of lateral trunk flexion that can be reduced by passive mobilization or supine positioning (PS≥10) (Doherty et. al., 2011);
• Camptocormia defined as a flexion (at least 5°) in the sagittal plane originating in the thoracolumbar spine, (classified as upper and lower), manifesting during standing and walking and completely subside in recumbent position (Pandey et. al., 2016);
• Hoehn \& Yahr (H\&Y) stage \<4 in "ON" medication phase.
• Informed consent to participate in the study

You may not qualify if:

• Severe dyskinesia or "on-off" fluctuations;
• PD medication modification in the 3 months preceding enrollment into the study;
• Need for assistive devices to rise from a chair or bed; somatic sensation deficits involving the legs;
• Vestibular disorders or paroxysmal vertigo; other neurological, orthopaedic or cardiovascular co-morbidities

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

AOUI Verona

Verona, 37134, Italy

Location

Related Publications (3)

• Bartolo M, Serrao M, Tassorelli C, Don R, Ranavolo A, Draicchio F, Pacchetti C, Buscone S, Perrotta A, Furnari A, Bramanti P, Padua L, Pierelli F, Sandrini G. Four-week trunk-specific rehabilitation treatment improves lateral trunk flexion in Parkinson's disease. Mov Disord. 2010 Feb 15;25(3):325-31. doi: 10.1002/mds.23007.

  PMID: 20131386 BACKGROUND

• Doherty KM, van de Warrenburg BP, Peralta MC, Silveira-Moriyama L, Azulay JP, Gershanik OS, Bloem BR. Postural deformities in Parkinson's disease. Lancet Neurol. 2011 Jun;10(6):538-49. doi: 10.1016/S1474-4422(11)70067-9. Epub 2011 Apr 22.

  PMID: 21514890 RESULT

• Gandolfi M, Tinazzi M, Magrinelli F, Busselli G, Dimitrova E, Polo N, Manganotti P, Fasano A, Smania N, Geroin C. Four-week trunk-specific exercise program decreases forward trunk flexion in Parkinson's disease: A single-blinded, randomized controlled trial. Parkinsonism Relat Disord. 2019 Jul;64:268-274. doi: 10.1016/j.parkreldis.2019.05.006. Epub 2019 May 3.

  PMID: 31097299 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Michele Tinazzi, PhD

  Universita di Verona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded. Patients will be specifically asked not to discuss their treatment during assessments. Examiner will be requested to inform the research coordinator if he will discover to which group a patient belonged, and they will periodically be questioned by the coordinator about this.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of UOC Neurorehabilitation

Model Details: Parallel Assignment. Single-blind RCT with two parallel group

Study Record Dates

• First Submitted: September 1, 2018
• First Posted: November 15, 2018
• Study Start: January 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: November 30, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)