Rehabilitation in Patients With Progressive Supranuclear Palsy

Progressive Supranuclear Palsy Clinical Trial

— PSP-MIRTLoko  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109393
• Other study ID #: PSP-MIRTLoko
• Secondary ID: PSP MIRT-Loko 00
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: December 5, 2016
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Local Scientific Committee and Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paralysis
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Other:
• MIRT
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
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.

Locations

Country	Name	City	State
Italy	Ospedale Generale di Zona "Moriggia-Pelascini"	Gravedona	Como

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSPRS	PSP Rating Scale	One month	No
Secondary	BBS	Berg Balance Scale	One month	No
Secondary	NoF	Number of falls	One month	No