Hallux Mobilization in Patients With Parkinson's Disease

NCT ID: NCT02098642

Last Updated: 2014-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-02-28

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.

Detailed Description

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. The main families of drugs useful for treating motor symptoms are levodopa dopamine agonists and Monoamine oxidases-B inhibitors.A multidisciplinary intensive rehabilitation treatment (MIRT) is able to improve different parameters in PD that are poorly responsive to the pharmacological 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 in patients with PD. In this course, we will evaluate whether passive mobilization of this joint, lead to positive effects on the freezing of gait and on the festination.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

MIRT

Intervention Type: 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.

Mobilization of the metatarsophalangeal joint of the hallux

Intervention Type: OTHER

MIRT and 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)

MIRT

Intervention Type: 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.

Interventions

MIRT

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.

Intervention Type: OTHER

Mobilization of the metatarsophalangeal joint of the hallux

MIRT and mobilization of the metatarsophalangeal joint of the hallux

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

PD patients stage 3 H&Y with FOG

Exclusion Criteria

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

• Minimum Eligible Age: 49 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Frazzitta, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Generale Di Zona Moriggia-Pelascini

Locations

Parkinson's Disease and Movement Disorders Rehabilitation Unit

Gravedona, Como, Italy

Countries

Italy

Other Identifiers

Hallux PD 001

Identifier Type: OTHER

Identifier Source: secondary_id

HalluxPD001

Identifier Type: -

Identifier Source: org_study_id