Effects of GE-O System on Gait Impairments in Multiple Sclerosis Subjects

NCT02459821 | Unknown DMC

• 1 other identifier: GEO-SM2012JP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Multiple sclerosis (MS) is the most common non-traumatic cause of neurologic disability in young adults,affecting mobility and ambulation in the majority of patients. At least 50% of individuals with MS will require an assistive device to ambulate within ten years of diagnosis. Impaired mobility is one of the top three factors associated with inability to continue working. In addition,impaired mobility and the inability to walk functionally translate into significant costs for personal assistance, medical complications, and lost wages because of unemployment. Clearly,maximizing the ability to ambulate, as well as perform safe and effective transfers,is a fundamental goal in the management of individuals with MS. None of the currently available MS disease-modifying medications have been shown to stop or reverse gait disability. Repetitive locomotor training is an innovative approach in gait disturbances in patients with MS. Only scant data on this issue is available and all the studies have been performed by means of treadmill training or robot assisted gait training (RAGT) approaches. The recent introduction of a robotic device to gait rehabilitation showed a significant improvement in gait ability in patients with neurological disease due to the possibility of being trained under a graduated body weight support condition and being being guided to reproduce a physiologic gait pattern. In 2010 a novel device called GE-O System was developed. It enables patients to repetitively practice walking on the floor and also climb up and down stairs. To date, the effectiveness of this novel device has not yet been evaluated in patients with MS. The aims of the study are as follows: to evaluate the effectiveness of a specific gait training program consisting of the GE-O System in patients with MS in improving balance and walking ability,reducing fatigue,the frequency of falls,the fear of falling and disability in activities of daily living and finally,improving quality of life.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Gait rehabilitation; Quality of life; Stair climbing; Robotic

Outcome Measures

Primary Outcomes (1)

• 6-Minute Walking Test (meters)

  Change from Baseline in meters at 6 weeks

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

Secondary Outcomes (8)

• 10-Metre Walking Test (seconds)

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

• Berg Balance Scale

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

• Activities-specific Balance Confidence Scale

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

• Fatigue Severity Scale

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

• Stair Climbing Test (seconds)

  All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

Study Arms (2)

Robot-assisted gait training group

EXPERIMENTAL

The first group will be subjected to RAGT for 9 weeks (2 sessions/ week) with a total of 18 sessions by mean of GE-O System (9). During each session, the patients will practice 15 to 20 min of simulated floor walking followed by 5 to 10 min of repetitive simulated stair climbing up and down. Breaks will be optional, but uninterrupted training intervals of at least 5 min for simulated floor walking and 3 min of simulated stair climbing will be required. When the patient reaches the maximum amount of time, speed of gait will then be progressively increased. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles.

Other: GE-O SYSTEM

Conventional training group

ACTIVE COMPARATOR

The group will be subjected to conventional gait training for 9 weeks (2 sessions/week) with a total of 18 sessions. Each session will last altogether 50 minutes, the first 30 minutes will be dedicated to gait and stair climbing up and down training while the last 20 minutes to stretch the lower limb's muscles.

Other: Conventional training

Interventions

GE-O SYSTEM OTHER

The first group will be subjected to RAGT for 9 weeks (2 sessions/ week) with a total of 18 sessions by mean of GE-O System (9). During each session, the patients will practice 15 to 20 min of simulated floor walking followed by 5 to 10 min of repetitive simulated stair climbing up and down. Breaks will be optional, but uninterrupted training intervals of at least 5 min for simulated floor walking and 3 min of simulated stair climbing will be required. When the patient reaches the maximum amount of time, speed of gait will then be progressively increased. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles.

Robot-assisted gait training group

Conventional training OTHER

The conventional walking group will be subjected to a conventional gait training for 9 weeks (2 sessions/week) with a total of 18 sessions. Each session will last altogether 50 minutes, the first 30 minutes will be dedicated to gait and stair climbing up and down training while the last 20 minutes to stretch the lower limb's muscles.

Conventional training group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expanded Disability Status Scale (EDSS) between 3 and 6.5;
• Mini Mental Examination State \>24;
• Absence of cognitive impairment;
• Age \<75 years;
• Absence of heart failure;
• Ability to sit without trunk support;
• Ability to stand for at least 10 seconds with support;
• Absence of concurrent neurological or orthopaedic diseases that interfere with deambulation;

You may not qualify if:

• Those patients with disease reccurence that worsens significantly during the 8 weeks before recruitment;
• changes in pharmacological therapy that could modified disease course in the previous three months;
• changes in pharmacological therapy for fatigue treatment in the previous three months;
• performance of any type of rehabilitation treatment in the month prior to recruitment.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (2)

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona

Verona, Italy, Verona, 37134, Italy

Location

prof. Smania Nicola

Verona, Verona, 37134, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nicola Smania, MD

  Neuromotor and Cognitive Rehabilitation Center Department of Neurological and Movement Sciences University of Verona, Verona, Italy P.zza L.A. Scuro, 10 37134 Verona, Italia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Nicola Smania

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: June 2, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 12, 2016

Record last verified: 2016-09

Locations

IT (2)