Neurorehabilitation of Sequence Effect in Parkinson's Disease

NCT04921748 | Completed

• 1 other identifier: Neurorehab in PD
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The sequence effect (SE), defined as a reduction in amplitude of repetitive movements, is a common clinical feature of Parkinson's disease (PD), being a major contributor to freezing of gait (FOG). During walking, SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination (dSE). The investigators studied the effect of a 4-week rehabilitation program on the destination sequence effect in patients affected by Parkinson's disease with and without Freezing of Gait. All subjects were evaluated with inertial gait analysis for dSE recording.

Conditions

Parkinson Disease; Freezing of Gait

Keywords

Movement disorders; Gait analysis; Hypokinesia; Basal ganglia; Functional indipendence

Outcome Measures

Primary Outcomes (1)

• Destination sequence effect (dSE) modifications

  Using an inertial gait analysis we will explore the modifications of destination sequence effect in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

  Change from baseline (T0) to four weeks (T1)

Secondary Outcomes (13)

• Between-group comparison of dSE

  Baseline (T0)

• Gait hypokinesia modifications

  Change from baseline (T0) to four weeks (T1)

• Speed modifications

  Change from baseline (T0) to four weeks (T1)

• Cadence modifications

  Change from baseline (T0) to four weeks (T1)

• Stride duration modifications

  Change from baseline (T0) to four weeks (T1)

Study Arms (2)

PD+FOG group

Patients affected by Parkinson's Disease with freezing of gait (PD+FOG group)

Procedure: Neurorehabilitation

PD-FOG group

Patients affected by Parkinson's Disease without freezing of gait (PD+FOG group)

Procedure: Neurorehabilitation

Interventions

Neurorehabilitation PROCEDURE

All patients will be treated with an in-hospital rehabilitation program focused on the rehabilitation of gait disorder in PD with 90-minute daily sessions, 6 days a week (Monday through Saturday) for four weeks. The rehabilitation treatment includes passive, active-assisted, and active exercises, isotonic and isometric exercises for the major muscles of the limbs and trunk, cardiovascular warm-up exercises, muscle stretching exercises for functional purposes, balance training exercises, specific motor exercise for hypokinesia, and 45 minutes of overground gait training delivered without devices or cueing The rehabilitation program is the same in PD patients with and without FOG.

Also known as: Rehabilitation, Physical therapy

PD+FOG group; PD-FOG group

Eligibility Criteria

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

Study Population

Patients affected by Idiopathic Parkinson's disease with and without freezing of gait to be consecutively enroll among those attending the Neurorehabilitation Department of the IRCCS Mondino Foundation (Pavia, Italy)

You may qualify if:

• Idiopathic Parkinson's disease
• Hoehn and Yahr stage between I and IV
• Mini-Mental State Examination score above 24.

You may not qualify if:

• Major psychiatric or other neurological conditions,
• Rheumatological diseases
• Ophthalmic diseases
• Orthopedic diseases
• Ongoing or previous treatment with neuroleptic drugs
• Patients with deep brain stimulation
• Any change in dose or regimen of the anti-parkinsonian therapy in the last month before enrolment.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

IRCCS Mondino Foundation

Pavia, 27100, Italy

Location

Related Publications (2)

• Kang SY, Wasaka T, Shamim EA, Auh S, Ueki Y, Lopez GJ, Kida T, Jin SH, Dang N, Hallett M. Characteristics of the sequence effect in Parkinson's disease. Mov Disord. 2010 Oct 15;25(13):2148-55. doi: 10.1002/mds.23251.

  PMID: 20669182 BACKGROUND

• Cao SS, Yuan XZ, Wang SH, Taximaimaiti R, Wang XP. Transverse Strips Instead of Wearable Laser Lights Alleviate the Sequence Effect Toward a Destination in Parkinson's Disease Patients With Freezing of Gait. Front Neurol. 2020 Aug 12;11:838. doi: 10.3389/fneur.2020.00838. eCollection 2020.

  PMID: 32903360 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Hypokinesia

Interventions

Neurological Rehabilitation; Rehabilitation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Roberto De Icco, MD

  IRCCS Mondino Foundation, Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: August 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: February 28, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

IT (1)