Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01883310
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2013-06-18
Brief Title:
Task-oriented Circuit Training Combined With Cerebellar tDCS in Multiple Sclerosis Subjects
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
The Effects of a Task-oriented Circuit Training Combined With Cerebellar Transcranial Direct Current Stimulation on Locomotor Function Balance and Mobility in Multiple Sclerosis Subjects
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aims of the study
This is a double-blind randomized-controlled trial to test the effects of a task oriented training combined with cerebellar transcranial direct current stimulation on locomotor function mobility and balance in multiple sclerosis subjects with moderate gait impairments EDSS 4-55
Subjects and methods 30 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic University Hospital Ferrara Informed consent will be obtained Participants enrolled will included in 2 different treatment groups Task Oriented Circuit Training TOCT anodal cerebellar transcranial direct current stimulation experimental group and TOCT sham transcranial direct current stimulation over the cerebellum control group The group with anodal transcranial direct current stimulation will receive continuous stimulation with intensity of 2 mA during the first 15 minutes of functional circuit training In the sham session anodal transcranial direct current stimulation was applied for 30 s and then shut off Each subject will receive 10 task-oriented training sessions over 2 weeks 5 sessionsweek 3 subjects with a supervisor physiotherapist will take part at the TOCT During the stimulation sessions both the subject and the researcher responsible for carrying out clinical tests will be unaware of the type of stimulation set
Treatment efficacy outcome measures will be clinical test for gait speed Timed 25-Foot Walk walking endurance six minute walking test balance Dynamic Gait Index and mobility Time Up and Go Test self-assessment questionnaire for motor fatigue Fatigue Severity Scale FSS and quality of life Short Form 36 Health Survey
Outcome measures will be assessed the week prior to treatment initiation T0 the week after the end of treatment T1 and at 3 months follow-up T3 to evaluate treatments retention by a clinician blinded to the treatment At the end of each session the subject will complete a questionnaire where report side effects due to stimulation headache neck pain burning redness andor itching in the site of stimulation
This is a double-blind randomized-controlled trial to test the effects of a task oriented training combined with cerebellar transcranial direct current stimulation on locomotor function mobility and balance in multiple sclerosis subjects with moderate gait impairments EDSS 4-55
Subjects and methods 30 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic University Hospital Ferrara Informed consent will be obtained Participants enrolled will included in 2 different treatment groups Task Oriented Circuit Training TOCT anodal cerebellar transcranial direct current stimulation experimental group and TOCT sham transcranial direct current stimulation over the cerebellum control group The group with anodal transcranial direct current stimulation will receive continuous stimulation with intensity of 2 mA during the first 15 minutes of functional circuit training In the sham session anodal transcranial direct current stimulation was applied for 30 s and then shut off Each subject will receive 10 task-oriented training sessions over 2 weeks 5 sessionsweek 3 subjects with a supervisor physiotherapist will take part at the TOCT During the stimulation sessions both the subject and the researcher responsible for carrying out clinical tests will be unaware of the type of stimulation set
Treatment efficacy outcome measures will be clinical test for gait speed Timed 25-Foot Walk walking endurance six minute walking test balance Dynamic Gait Index and mobility Time Up and Go Test self-assessment questionnaire for motor fatigue Fatigue Severity Scale FSS and quality of life Short Form 36 Health Survey
Outcome measures will be assessed the week prior to treatment initiation T0 the week after the end of treatment T1 and at 3 months follow-up T3 to evaluate treatments retention by a clinician blinded to the treatment At the end of each session the subject will complete a questionnaire where report side effects due to stimulation headache neck pain burning redness andor itching in the site of stimulation
Detailed Description:
The inclusion criteria will be
males and females community dwelling age 18 or older
diagnosis of multiple sclerosis in a stable phase which will be defined as a chronic progressive or relapsing-remitting pattern with no relapse during the last 3 months
moderate gait impairments referred to Expanded Disability Status Scale between 4 and 55 this EDSS scores refers to people with restricted ambulation who do not need walking aids
males and females community dwelling age 18 or older
diagnosis of multiple sclerosis in a stable phase which will be defined as a chronic progressive or relapsing-remitting pattern with no relapse during the last 3 months
moderate gait impairments referred to Expanded Disability Status Scale between 4 and 55 this EDSS scores refers to people with restricted ambulation who do not need walking aids
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None