Rehabilitation in Patients With Progressive Supranuclear Palsy

Not Applicable

Completed

• Conditions: Progressive Supranuclear Palsy
• Interventions: Other: MIRT+Lokomat; Other: MIRT

• Registration Number: NCT02109393
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-25
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIRT+Lokomat group	MIRT+Lokomat	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.
MIRT group	MIRT	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.

Primary Outcome Measures

Name	Time	Method
PSPRS	One month	PSP Rating Scale

Secondary Outcome Measures

Name	Time	Method
BBS	One month	Berg Balance Scale
NoF	One month	Number of falls

Trial Locations

Locations (1)

Ospedale Generale di Zona "Moriggia-Pelascini"; 🇮🇹 Gravedona, Como, Italy