Clinical trial NCT01435694: Robot-assisted Gait Training in Multiple Sclerosis Subjects
Official title: The Effects of Robot-assisted Gait Training on Locomotor Function and Motor Unit Firing in Multiple Sclerosis Subjects With Severe Gait Impairments. A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
gait rehabilitation
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero, Universitaria Pisana
First posted: 2011-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aims of the study:

This is a randomized-controlled trial to test the effects of robot-assisted gait training on locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait impairments. The control group will be treat with conventional physical therapy.

Subjects and methods:

60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics.

Informed consent will be obtained. Participants will be randomized to Robot-assisted gait training (experimental group) or conventional therapy (control group) through a randomization stratification approach, according to a block randomization of 4.

The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2 sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks (2 sessions/week), that will focus on gait training.

Primary outcome measures will be both neurophysiological measures (motor unit firing rate characteristics) and clinical test for gait speed (10m walking test). Secondary outcome measures will include: clinical tests of walking endurance (six minute walking test), balance (Berg Balance Test) and mobility (Up and Go Test).

Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored. Subject acceptance and confidence in the treatments will be track with a Visual Analog Scale. Outcome measures will be assessed the week prior to treatment initiation (T0), after 6 sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to evaluate treatments retention, by a clinician blinded to the treatment.


Eligibility criteria: Inclusion Criteria:

* males and females, community dwelling, age 18 or older
* diagnosis of multiple sclerosis in a stable phase, with relapses \> 6 months prior to study enrollment
* moderate to severe gait impairments referred to Expanded Disability Status Scale (EDSS) between 6 and 7

Exclusion Criteria:

* neurologic conditions in addition to multiple sclerosis that may affect motor function
* medical conditions likely to interfere with the ability to safely complete the study
* impaired cognitive functioning: Mini Mental Status Examination \< 24
* severe lower-extremities spasticity or contractures that may limit range of motion(Ashworth score \>4 for hip, knee or ankle flexors/extensors

Primary outcomes:
measure: motor unit firing rate characteristics
timeFrame: 12 months
Secondary outcomes:
measure: walking endurance
timeFrame: 12 months
measure: mobility
timeFrame: 12 months
measure: balance
timeFrame: 12 months
measure: gait speed
timeFrame: 12 months
measure: Fatigue
timeFrame: 12 months
measure: quality of life
timeFrame: 12 months
measure: depression
timeFrame: 12 months
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Physical Medicine and Rehabilitation Department
Study officials:
affiliation: Ferrara University Hospital
name: Sofia Straudi, MD
role: STUDY_CHAIR
affiliation: Pisana University Hospital
name: Carmelo Chisari, MD
role: STUDY_CHAIR
affiliation: Ferrara University Hospital
name: Nino Basaglia, MD
role: PRINCIPAL_INVESTIGATOR
References: