Brief Title
Rehabilitation in Patients With Progressive Supranuclear Palsy
Official Title
Rehabilitation in Patients With Progressive Supranuclear Palsy: Effectiveness of Two Intensive Protocols
Brief Summary
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.
Study Type
Interventional
Primary Outcome
PSPRS
Secondary Outcome
BBS
Condition
Progressive Supranuclear Palsy
Intervention
MIRT
Study Arms / Comparison Groups
MIRT group
Description: This group underwent a 4-weeks MIRT exploiting the use of a treadmill-plus (treadmill associated with visual cues and auditory feedbacks). Inclusion criteria: a) diagnosis of idiopathic 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
24
Start Date
April 2014
Completion Date
December 2015
Primary Completion Date
December 2015
Eligibility Criteria
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.
Gender
All
Ages
55 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Giuseppe Frazzitta, MD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT02109393
Organization ID
PSP-MIRTLoko
Secondary IDs
PSP MIRT-Loko 001
Responsible Party
Sponsor
Study Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Study Sponsor
Giuseppe Frazzitta, MD, Principal Investigator, Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy
Verification Date
November 2016