Hallux Mobilization in Patients With Parkinson's Disease

NCT02098642 | Completed DMC

• 2 other identifiers: HalluxPD001Hallux PD 001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease is a degenerative disorder of the central nervous system. The motor symptoms of Parkinson's disease result from the death of dopamine-generating cells in the substantia nigra, a region of the midbrain; the cause of this cell death is unknown. Early in the course of the disease, the most obvious symptoms are movement-related; these include shaking, rigidity, slowness of movement and difficulty with walking and gait. A multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different parameters in PD that are poorly responsive to dopaminergic therapy. In this study, we aim to understand whether the passive mobilization of the metatarsophalangeal joint of the hallux determines an increase in the joint range in this district, allowing to improve, at least, the gait.

Conditions

Parkinson Disease

Keywords

Gait Disturbances; Metatarsophalangeal joint

Outcome Measures

Primary Outcomes (1)

• FOGQ

  Freezing of Gait Questionnaire Value

  One month

Secondary Outcomes (3)

• UPDRS III

  One month

• BBS

  One month

• Hallux

  One month

Study Arms (2)

Patients with passive joint mobilization

Patients diagnosed with PD according to the Gelb et al in Hoen\&Yahr stage 3, with Freezing of Gait and treated with a Multidisciplinary intensive rehabilitation treatment (MIRT), including the mobilization of the metatarsophalangeal joint of the hallux

Other: MIRT; Other: Mobilization of the metatarsophalangeal joint of the hallux

No passive joint mobilization

Patients diagnosed with PD according to the Gelb et al in Hoen\&Yahr stage 3, with Freezing of Gait and treated with a Multidisciplinary intensive rehabilitation treatment (MIRT)

Other: MIRT

Interventions

MIRT OTHER

A 4-week cycle of physiotherapy that entailed three daily sessions, 5 days a week. The first session comprised cardiovascular warm-up activities, relaxation exercises, muscle-stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, and exercises to improve the functionality of abdominal muscles and postural changes in the supine position. The second session included exercises to improve balance and gait using a stabilometric platform with a visual cue and treadmill training associated with auditory and visual cues (treadmill plus). The last was an occupational therapy session with the aim of improving autonomy in daily living activities.

No passive joint mobilization; Patients with passive joint mobilization

Mobilization of the metatarsophalangeal joint of the hallux OTHER

MIRT and mobilization of the metatarsophalangeal joint of the hallux

Patients with passive joint mobilization

Eligibility Criteria

• Age: 49 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PD

You may qualify if:

• PD patients stage 3 H\&Y with FOG

You may not qualify if:

• we excluded patients with atypical parkinsonism, with other concomitant neurological conditions (with cerebrovascular etc.), with joint disorders, muscle disorders or with other orthopedic conditions.

Sponsors & Collaborators

• Ospedale Generale Di Zona Moriggia-Pelascini: lead

Study Sites (1)

Parkinson's Disease and Movement Disorders Rehabilitation Unit

Gravedona, Como, 22015, Italy

Location

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

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

Study Officials

• Giuseppe Frazzitta, MD

  Ospedale Generale Di Zona Moriggia-Pelascini

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 28, 2014
• Study Start: March 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

IT (1)