Robot-assisted Gait Training in Multiple Sclerosis Subjects

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435694
• Other study ID #: FISM_grant_2010
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: January 15, 2014
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Lokomat (Hocoma, Switzerland)

• Conventional Therapy

Locations

Country	Name	City	State
Italy	Physical Medicine and Rehabilitation Department	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Ferrara	Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	motor unit firing rate characteristics	It will be performed through the analysis of superficial EMG signals during isometric knee extension.	12 months	No
Secondary	walking endurance	six minute walking test	12 months	No
Secondary	mobility	Timed Up and Go Test	12 months	No
Secondary	balance	Berg Balance Test	12 months	No
Secondary	gait speed	10 meter test	12 months	No
Secondary	Fatigue	Fatigue Severy Scale	12 months	No
Secondary	quality of life	SF-36	12 months	No
Secondary	depression	patient health questionnaire (PHQ-9)	12 months	No