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

Primary Purpose

Progressive Supranuclear Palsy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MIRT
MIRT+Lokomat
Sponsored by
Ospedale Generale Di Zona Moriggia-Pelascini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring Rehabilitation, Robot-assisted walking training, Treadmill, Lokomat

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ospedale Generale di Zona "Moriggia-Pelascini"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MIRT group

MIRT+Lokomat group

Arm 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.

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.

Outcomes

Primary Outcome Measures

PSPRS
PSP Rating Scale

Secondary Outcome Measures

BBS
Berg Balance Scale
NoF
Number of falls

Full Information

First Posted
March 25, 2014
Last Updated
December 5, 2016
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
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1. Study Identification

Unique Protocol Identification Number
NCT02109393
Brief Title
Rehabilitation in Patients With Progressive Supranuclear Palsy
Acronym
PSP-MIRTLoko
Official Title
Rehabilitation in Patients With Progressive Supranuclear Palsy: Effectiveness of Two Intensive Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy
Keywords
Rehabilitation, Robot-assisted walking training, Treadmill, Lokomat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIRT group
Arm Type
Experimental
Arm 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.
Arm Title
MIRT+Lokomat group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
MIRT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
MIRT+Lokomat
Intervention Description
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 Outcome Measure Information:
Title
PSPRS
Description
PSP Rating Scale
Time Frame
One month
Secondary Outcome Measure Information:
Title
BBS
Description
Berg Balance Scale
Time Frame
One month
Title
NoF
Description
Number of falls
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Organizational Affiliation
Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Generale di Zona "Moriggia-Pelascini"
City
Gravedona
State/Province
Como
ZIP/Postal Code
22015
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28158197
Citation
Clerici I, Ferrazzoli D, Maestri R, Bossio F, Zivi I, Canesi M, Pezzoli G, Frazzitta G. Rehabilitation in progressive supranuclear palsy: Effectiveness of two multidisciplinary treatments. PLoS One. 2017 Feb 3;12(2):e0170927. doi: 10.1371/journal.pone.0170927. eCollection 2017.
Results Reference
derived

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Rehabilitation in Patients With Progressive Supranuclear Palsy

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