Robot Walking Rehabilitation in Parkinson's Disease

NCT01668407 | Completed

• 1 other identifier: RP 04/12
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

The effectiveness of non-pharmacological treatment on gait impairment on Parkinson Disease (PD) such as exercises has been demonstrated; in particular an example for patient tailored exercises is physiotherapy. The goal of physiotherapy treatment is to enable PD patients to maintain their maximum level of mobility, activity, and independence. Several systematic reviews and clinical studies have shown that physical therapy can contribute to minimize the disabling effects of motor and sensory impairments in order to enhance participation in societal roles and quality of life. The use of electromechanical devices such as treadmill training (a supplement to conventional therapies) in the last years has also been used with PD patients and a systematic Cochrane has been conducted by Mehrholz in 2010 to assess the effectiveness and acceptability of treadmill training in the treatment of gait disorders for patients with PD. In the last years new robotic assisted device can be used in gait training in neurological disorder. Till now only few studies, have focused on the effects of exoskeleton or end effector robot-assisted training in PD patients, with a interesting preliminary results.

Conditions

Idiopathic Parkinson's Disease; Progressive Supranuclear Palsy

Keywords

Parkinson's disease; PSP; Robot; Gait rehabilitation

Outcome Measures

Primary Outcomes (1)

• 6 minutes walking test.

  The 6 minuts walking test as primary outcome assessments will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot session) (T1) (no later than 1 day \> last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).

  Change from Baseline in gait speed at 6 months follow up.

Secondary Outcomes (2)

• Time Up and Go test.

  baseline, weekly during intervention, 6 months follow up.

• Gait Parameters

  baseline, weekly during intervention, 6 months follow up.

Study Arms (2)

Robot-Assisted Gait Training (RAGT)

EXPERIMENTAL

Robot-Assisted Gait Training (RAGT): Subjects (at least 40) will undergo inpatient rehabilitation consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45 min with a partial body weight support (BWS). All participants started with 30-40% BWS and an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h before BWS will be decreased.

Device: Robot-Assisted Gait Training (RAGT)

Treadmill Gait Training (TT)

ACTIVE COMPARATOR

Treadmill Gait Training (TT): Subjects (at least 40) will undergo inpatient rehabilitation consisting of a treatment cycle using the treadmill device, according to individually tailored exercise scheduling. The practice included treadmill walking at variable speed for 45 minutes. All participants will start at an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h.

Procedure: Treadmill Gait Training (TT)

Interventions

Robot-Assisted Gait Training (RAGT) DEVICE

Subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45 min with a partial body weight support (BWS). All participants started with 30-40% BWS and an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h before BWS will be decreased.

Also known as: End effector G-EO System

Robot-Assisted Gait Training (RAGT)

Treadmill Gait Training (TT) PROCEDURE

Subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the treadmill device, according to individually tailored exercise scheduling. The practice included treadmill walking at variable speed for 45 minutes. All participants will start at an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h. All the treatment consists of 20 sessions for the lower limbs, each lasting 45 minutes, 5 days a week for 4 weeks.

Also known as: TREADMILL

Treadmill Gait Training (TT)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria,
• Age between 18-80;
• Able to walk 25 feet unassisted or with minimal assistance;
• On stable doses of Parkinson's medications for at least 2 weeks prior to study onset;
• Endurance sufficient to stand at least 20 minutes unassisted per patient report.

You may not qualify if:

• Other significant neurological or orthopedic problems.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (3)

Polytecnic University of Marche

Ancona, Italy

Location

San Raffaele Cassino

Cassino, 03043, Italy

Location

IRCCS San Raffaele Pisana

Rome, 00163, Italy

Location

Related Publications (2)

• Sale P, Stocchi F, Galafate D, De Pandis MF, Le Pera D, Sova I, Galli M, Foti C, Franceschini M. Effects of robot assisted gait training in progressive supranuclear palsy (PSP): a preliminary report. Front Hum Neurosci. 2014 Apr 17;8:207. doi: 10.3389/fnhum.2014.00207. eCollection 2014.

  PMID: 24860459 DERIVED

• Sale P, De Pandis MF, Le Pera D, Sova I, Cimolin V, Ancillao A, Albertini G, Galli M, Stocchi F, Franceschini M. Robot-assisted walking training for individuals with Parkinson's disease: a pilot randomized controlled trial. BMC Neurol. 2013 May 24;13:50. doi: 10.1186/1471-2377-13-50.

  PMID: 23706025 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Supranuclear Palsy, Progressive

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Patrizio Sale, MD

  IRCCS San Raffale Pisana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: August 20, 2012
• Study Start: March 30, 2012
• Primary Completion: August 30, 2015
• Study Completion: March 31, 2016
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

IT (3)