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OpenTrials
Completed

NCT Number: NCT02109393

Rehabilitation in Patients With Progressive Supranuclear Palsy

The investigators evaluate whether an aerobic, intensive, goal based and multidisciplinary rehabilitation treatment, previously conceived for Parkinson's disease, is effective for patients with progressive supranuclear palsy and whether a driven gait orthosis (Lokomat) can provide further benefits.

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Key information

Conditions

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

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Generale di Zona "Moriggia-Pelascini"

Gravedona, Como, 22015, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

a) diagnosis of PSP in accordance to the NINDS-SPSP International Criteria (Litvan et al., 1996), b) age between 55 and 85 c) ability to walk unassisted for at least 6 meters, d) stable dopaminergic drugs dosage in the month preceding the admission to the study

Exclusion criteria

a) any others significant neurological or orthopedic disorders, b) osteoarthritis, osteoporosis, cutaneous lesions and/or other pressure wounds, c) body weight exceeding 135 kg (the weight limit for the use of Lokomat®), respiratory and cardiovascular diseases.

Treatment and study plan

MIRT

Other

It consists of a 4-weeks physical therapy which entails four daily sessions for five days. All treatments are performed in aerobic condition. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with physical therapist. The second session includes aerobic and repetitive exercises to improve balance and gait using different devices: a posturographic platform with visual cues, cycloergometer, treadmill-plus. The third is a session of occupational therapy. The last session includes one hour of speech therapy.

All patients undergo 20-minutes treadmill-plus training per day, 5 times a week, for 4 weeks.

MIRT+Lokomat

Other

It consists of a 4-weeks physical therapy which entails four daily sessions for five days. All treatments are performed in aerobic condition. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with physical therapist. The second session includes aerobic and repetitive exercises to improve balance and gait using different devices: a posturographic platform with visual cues and cycloergometer. The third is a session of occupational therapy to improve autonomy in activities of daily life. The last session includes one hour of speech therapy. All patients undergo 20-minutes Lokomat® training per day in spite of treadmill-plus.

Primary outcomes

  1. PSPRS

    Time frame: One month

    PSP Rating Scale

Secondary outcomes

  1. BBS

    Time frame: One month

    Berg Balance Scale

  2. NoF

    Time frame: One month

    Number of falls

Sponsors and collaborators

Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Other

Registry information

Official study title

Rehabilitation in Patients With Progressive Supranuclear Palsy: Effectiveness of Two Intensive Protocols

Acronym: PSP-MIRTLoko

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2014
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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