Enhancing balance and gait in patients with Multiple Sclerosis – combined use of balance training with non-invasive brain stimulation

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: Participants will receive 12 treatment sessions over 6 weeks (2 per week) at the Perron Institute. Each treatment will comprise brain stimulation (real or sham tDCS) for 20 minutes followed by 1 hour of one on one supervised balance therapy provided by a neurophysiotherapist. tDCS will be administered by a trained physiotherapist or clinical psychologist. Transcranial direct current stimulation (tDCS) is a non‐invasive technique that changes the excitability of brain cells by applying a weak direct current (1‐2mA) to the brain. The method of applying tDCS involves placing saline‐soaked sponge electrodes onto the skin of the scalp. These electrodes are connected to a battery driven direct current stimulator. tDCS is painless, inexpensive, has no major adverse effects and is easy to apply clinically. Each balance training session will be one hour in duration and will comprise the 2 balance treatments described below. A rest break (5‐10 minutes) will be given between the 2 treatments to minimize fatigue. Treatment 1 (25 minutes). Impairment based physiotherapy would specifically target problems identified on assessment. This would include poor posture, reduced range of passive and active joint movement, reduced lower limb and core strength, use of compensatory movements, overactivity on one side etc. Treatment 2 (25 minutes). Task oriented functional therapy which would progress tasks in difficulty and repetition as performance improved. Tasks would include standing, stepping, turning, reaching, hopping, running and walking tasks, including steps and uneven surfaces. tDCS has been shown to improve motor function in stroke but has not been trialled in MS. Another kind of brain stimulation (rTMS) has been shown to benefit hand dexterity and lower limb spasticity in MS (Koch et al. 2008: Centoze et al. 2007). This study will use anodal tDCS, which increases brain excitability, and 2mA tDCS will be applied for 20 minutes prior to balance ther CONDITION: Multiple Sclerosis; ; Multiple Sclerosis Neurological ‐ Multiple sclerosis PRIMARY OUTCOME: Berg Balance Scale[single time point 1‐2 weeks (primary time point) and 6 months after completion of treatments] SECONDARY OUTCOME: 10m walk test, [single time point 1‐2 weeks and 6 months after completion of treatments] Activities‐specific Balance Confidence (ABC)[single time point 1‐2 weeks and 6 months after completion of treatments] Cognitive assessment using the Montreal Cognitive Assessment Tool (MoCA) ; [single time point 1‐2 weeks and 6 months after completion of treatments] Dizziness handicap inventory (DHI)[single time point 1‐2 weeks and 6 months after completion of treatments] Dynamic Gait Index, [single time point 1‐2 weeks and 6 months after completion of treatments] Fatigue Severity Scale (FSS)[single time point 1‐2 weeks and 6 months after completion of treatments] High level Mobility Assessment Tool (HiMAT), [single time point 1‐2 weeks and 6 months after completion of treatments] modified Barthel index, [single time point 1‐2 weeks and 6 months after completion of treatments] Mood assessments using the General Anxiety Disorder‐7 (GAD‐7) ; [single time point 1‐2 weeks and 6 months after completion of treatments] Mood assessments using the Patient Health Questionnaire‐9 (PHQ‐9)[single time point 1‐2 weeks and 6 months after completion of treatments] Multiple Sclerosis Quality of Life‐54 (MSQOL‐54) ; Based on: INCLUSION CRITERIA: 1. Adults (>18 years old) with definite diagnosis of Multiple Sclerosis (Relapsing Remitting, Secondary Progressive or Primary Progressive) 2. Mild to moderate balance impairment a. Symptoms of gait or balance impairment (including falls) b. Medical and physiotherapy assessment suggestive of balance impairment 3. EDSS < 6 ; [single time point 1‐2 weeks and 6 months after completion of treatments] Neurophysiological assessments using TMS (intra‐cortical facilitation)[single time point 1‐2 weeks and 6 months after completion of treatments] Neurophysiological assessments using TMS (intra‐cortical inhibition)[single time point 1‐2 weeks and 6 months after completion of treatments] Neurophysiological assessments using TMS (resting motor threshold)[single time point 1‐2 weeks and 6 months after completion of treatments] Neurophysiological assessments using TMS (stimulus response curve)[single time point 1‐2 weeks and 6 months after completion of treatments] Self reporting falls questionnaire ; Talbot, L. A., Musiol, R. J., et al. (2005). "Falls in young, middle‐aged and older community dwelling adults: perceived cause, environmental factors and injury." BMC Public Health 5(1): 86.[single time point 1‐2 weeks and 6 months after completion of treatments] Timed Up and Go Test, [single time point 1‐2 weeks and 6 months after completion of treatments] a. Able to walk at least 20m, +/ aid (need to be able to complete 10 Meter Walk Test and Dynamic Gait Index) b. Able to stand independently for at least 10 minutes (to complete the Sensory Organization Test on the Balance Master) c. Can step up and down 1 step with a maximum of 1 person assist
Epistemonikos ID: 61cc875a58bb48a21d69812a0958288281d32278
First added on: Aug 24, 2024