Rehabilitation in Patients With Progressive Supranuclear Palsy (PSP-MIRTLoko)
Rehabilitation in Patients With Progressive Supranuclear Palsy: Effectiveness of Two Intensive Protocols
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Como
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Gravedona, Como, Italy, 22015
- Ospedale Generale di Zona "Moriggia-Pelascini"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MIRT group
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. |
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. |
|
Experimental: MIRT+Lokomat group
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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PSPRS
Time Frame: One month
|
PSP Rating Scale
|
One month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BBS
Time Frame: One month
|
Berg Balance Scale
|
One month
|
|
NoF
Time Frame: One month
|
Number of falls
|
One month
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSP-MIRTLoko
- PSP MIRT-Loko 001 (Other Identifier: Ospedale Generale di Zona "Moriggia-Pelascini")
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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