Rehabilitation in Patients With Progressive Supranuclear Palsy

NCT ID: NCT02109393

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Progressive Supranuclear Palsy

Keywords

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Rehabilitation Robot-assisted walking training Treadmill Lokomat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

MIRT

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

MIRT+Lokomat

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Frazzitta, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy

Locations

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Ospedale Generale di Zona "Moriggia-Pelascini"

Gravedona, Como, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 28158197 (View on PubMed)

Other Identifiers

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PSP MIRT-Loko 001

Identifier Type: OTHER

Identifier Source: secondary_id

PSP-MIRTLoko

Identifier Type: -

Identifier Source: org_study_id