None listed
Conditions
Brief summary
Many people with stroke have walking and balance dysfunction. Sensory tongue stimulation (cranial nerve non-invasive neuromodulation – CNNINM) provided through a device called the Portable Neuromodulation Stimulator (PoNS) can stimulate regions in the brain that are important for balance and gait. This study will be a preliminary randomised controlled trial (RCT) of the PoNS combined with a structured task-specific rehabilitation program in stroke survivors undergoing inpatient rehabilitation.The study will be registered with the Therapeutic Goods Administration under the Clinical Trial Notification Scheme (device trial). Ten participants will be randomised to either a 2-week intensive balance and gait training program with a physiotherapist while using the PoNS (intervention), or to a 2-week intensive balance and gait training program with a physiotherapist only (control). Both the intervention and control programs will be conducted at the Royal Park Rehabilitation Centre, and will be additional to the patients' usual rehabilitation program. Training sessions will be tailored to the needs of each participant and comprise five main components: movement control, balance, gait, cognition and breathing and relaxation. Participants will be assessed on a range of outcome measures related to gait and balance, as well as self-perception of performance, depression, cognition and oculomotor function. Assessments will occur at baseline and post-intervention. The primary outcome measures will be the miniBEST Test, which assesses balance. This study will be the first systematic study of the PoNS in Australia, and will establish the safety and preliminary efficacy of the PoNS/training protocol. It will also provide data on which to base a sample size calculation for a future larger RCT.
Interventions
Participants with recent stroke will given sensory tongue stimulation (cranial nerve non-invasive neuromodulation – CNNINM) through a device called the Portable Neuromodulation Stimulator (PoNS). and concurrent intensive balance and gait training, in addition to usual rehabilitation. The battery-operated PoNS device is worn around the neck and has a mouthpiece with a hexagonally patterned array of gold-plated circular electrodes that goes into the mouth, resting on the top of the tongue, and i
Participants with recent stroke will given sensory tongue stimulation (cranial nerve non-invasive neuromodulation – CNNINM) through a device called the Portable Neuromodulation Stimulator (PoNS). and concurrent intensive balance and gait training, in addition to usual rehabilitation. The battery-operated PoNS device is worn around the neck and has a mouthpiece with a hexagonally patterned array of gold-plated circular electrodes that goes into the mouth, resting on the top of the tongue, and is held lightly in place by the lips and teeth. The tongue stimulation is provided concurrently with balance and gait training, and the intensity of stimulation can be adjusted for comfort. Participants will attend for treatment with an experienced physiotherapist twice daily for 1.5 hours, 5 days per week for 2 weeks.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 75 years 2. Diagnosis of stroke 3. Admitted for inpatient rehabilitation at the Royal Park Rehabilitation Centre 4. Have sufficient cognitive capacity to participate in this study (ascertained by the rehabilitation consultant).
Exclusion criteria
1. Major co-morbidities, especially other neurological disorders, uncontrolled pain, uncontrolled hypertension, brittle diabetes etc. 2. Oral health problems (e.g. gum disease, active cankers etc.) or a history of oral cancer, precluding them from safe participation in the study.
Outcome results
None listed