Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease

NCT03021408 | Unknown

• 1 other identifier: OGZonaMP-PD Gait Rehab
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the effectiveness of three different approaches for the rehabilitation of gait in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).

Conditions

PD; Gait Dysfunction, Neurologic; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 6-minute walking test (6MWT)

  Patient is first familiarized with the test by letting him/her go once forward and backward along a straight 15-m line on the ground in a gymnasium. Then, after 15 minutes rest, he/she is instructed to walk from end to end of the line for 6 minutes and to cover as much distance as possible. No encouragement is offered during the test and no cues are used.

  4 weeks

Secondary Outcomes (3)

• Average length of right and left steps

  4 weeks

• Coefficient of variance

  4 weeks

• Step cycle

  4 weeks

Study Arms (3)

MIRT + Treadmill

EXPERIMENTAL

In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues.

Other: MIRT + Treadmill

MIRT + Treadmill Plus

EXPERIMENTAL

In the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues.

Other: MIRT + Treadmill Plus

MIRT + Virtual Reality

EXPERIMENTAL

In the context of MIRT, the gait training in this group will be performed by using Virtual Reality with enhanced perceptions (visual, auditory, and haptic inputs).

Other: MIRT + Virtual Reality

Interventions

MIRT + Treadmill OTHER

PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill training twice per day, 5 times a week, for 4 weeks.

MIRT + Treadmill

MIRT + Treadmill Plus OTHER

PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill-plus training (with visual and auditory cues) twice per day, 5 times a week, for 4 weeks.

MIRT + Treadmill Plus

MIRT + Virtual Reality OTHER

PD patients will undergo a 4-week MIRT. All patients in the MIRT+Virtual Reality (VR) group will undergo 10-minutes VR training with enhanced perceptions (visual, auditory, and haptic inputs), twice per day, 5 times a week, for 4 weeks.

MIRT + Virtual Reality

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of "probable" idiopathic Parkinson's disease according to Gelb et al (Gelb, 1999);
• Mild to moderate stage of disease (stage 2-3) according to Hoehn \& Yahr scale;
• Ability to walk on treadmill;
• Visual and hearing capacity sufficient to perceive the cues;
• No cognitive impairment (Mini-Mental State Examination score ≥ 26);
• Stable pharmacological treatment since 2 weeks before admission and during rehabilitation;

You may not qualify if:

• Diagnosis of atypical or vascular Parkinsonism;
• Occurrence of cardiovascular, orthopaedic, peripheral nerves, musculoskeletal and vestibular disorders which could affect patient's locomotion or balance;
• Neuropsychiatric disturbances;
• Severe dyskinesia;
• Severe freezing of gait;

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

Study Sites (1)

"Moriggia-Pelascini" Hospital

Gravedona Ed Uniti, Como, 22015, Italy

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Frazzitta Giuseppe, MD

  "Moriggia-Pelascini" Hospital

  STUDY DIRECTOR

Central Study Contacts

Davide Ferrazzoli, MD

CONTACT

+393318643163; davideferrazzoli@gmail.com

Ilaria Zivi, MD

CONTACT

+39034492111; ilaria.zivi@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 7, 2017
• First Posted: January 13, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)