Rehabilitation in Patients With Progressive Supranuclear Palsy (PSP-MIRTLoko)

Ospedale Generale Di Zona Moriggia-Pelascini

Status: Completed

Conditions: Progressive Supranuclear Palsy

Treatments: Other: MIRT+Lokomat; Other: MIRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02109393

PSP MIRT-Loko 001 (Other Identifier)

PSP-MIRTLoko

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

MIRT group

Experimental 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.

Treatment:

Other: MIRT

MIRT+Lokomat group

Experimental group

Description:

This group underwent a 4-weeks MIRT involving the use of Lokomat® for 5 days per week in spite of treadmill-plus. 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.

Treatment:

Other: MIRT+Lokomat