None listed
Conditions
Brief summary
Intact postural control (balance) is essential for safe and effective movement. Age-related decline in postural control threatens everyday activity and reduced levels of mobility, and confidence and increased risk of falls and gait impairment. Evidence suggests that balance training improves mobility, confidence and spatial cognition and reduces falls. A recent advance is the use of sub-sensory threshold noisy galvanic vestibular stimulation (nGVS), which uses galvanic stimulation delivered with a gaussian noise signal to enhance weak sensory input and facilitate information processing in sensory systems. nGVS has been shown to improve postural control, cognition and gait parameters in older adults, people with vestibular disorders and people with Parkinson’s disease. This study assesses the effect of nGVS to alter balance and gait when delivered in conjunction with a group balance rehabilitation programme. Using nGVS to augment a balance programme is a novel use of this technology. If effective, this has the potential to enhance the effect of balance retraining reducing the profound and significant sequale of reduced mobility and falls to health. The Feasibility Study aim is to evaluate trial processes to determine if the design is feasible. A secondary aim is to evaluate the outcome measures to inform the design of a full RCT and also participant opinions of the intervention to refine the Full Study protocol. The aim of a subsequent Full Study is to determine if an 8 week balance rehabilitation programme augmented with noisy galvanic stimulation (nGVS) is effective in improving postural stability compared to either the balance programme with a sham nGVS or a no intervention control in older adults with moderate to high falls risk.
Interventions
Intervention: Participants will attend a rehabilitation exercise programme delivered in groups of 4-6 older adults by a physiotherapist twice a week for 8 weeks. An attendance record will be kept by the Physiotherapist running the programme. The exercise programme is a 50 minute, low intensity progressive programme based on standard principles of balance training focussing on the integration of the visual, vestibular and somatosensory systems. Types of exercises in the programme include; standing and walking on unstable surfaces, vestibular ocular habituation (head turning) exercises, and controlling limits of stability (standing with a progressively smaller base of support)- these will all be done at a Borg scale of exertion 11-12 (Exercises that require some exertion but not enough to speed up your breathing). The exercise session will conclude with 5-minutes static cycling at a Borg scale of perceived exertion of around 13 (Requiring moderate effort and speeds up your breathing but doesn’t make you out of breath). Treatment group participants will complete the exercise programme whilst receiving noisy Galvanic Stimulation (nGVS) for 45 minutes. Participants wear electrodes placed over the mastoid process by either the Physiotherapist or research assistant and attached to a commercially available galvanic stimulator (Softrex Medical). Staff will be trained in the application and use of the nGVS machines by a member of the research team experienced in their use. The nGVS machines are designed for research and will be programmed to the nGVS setting by an unblinded member of the research team and numbered with the participants study number. The nGVS is white noise GVS - a zero-mean random signal with equal intensities at different frequencies. The intensity is set at 0.5mA and is of imperceptable magnitude (the participant is unable to feel or hear the nGVS). Comparator/ Control group This study uses a 3-armed randomised double blinded, parallel, control trial design. There will be two groups that control for treatment effect, the sham group and the control group. The Sham Group will wear electrodes over the mastoid process applied by the Physiotherapist or Research assistant and attached to the galvanic stimulator which has been programmed to the sham setting by the unblinded researcher. As the nGVS is administered at a subsensory level neither the Therapist or participant will know whether they are receiving sham nGVS or nGVS. Sham group participants will partake in the same exercise programme as the treatment group participants. The Control Group will receive no intervention (nGVS or exercise programme) but will be offered the same balance rehabilitation programme as the treatment and sham group after the 6-month follow up assessment.
Sponsors
Study design
Eligibility
Inclusion criteria
Community-dwelling adults aged 65 and above or Maori/ Pasifika aged 55 and above at risk of falling according to the STEADI screening tool
Exclusion criteria
Neurological condition diagnosed by a medical practitioner A pacemaker or metal implants in the head or neck region Vertigo Unable to follow a three step instruction Unable to stand independently for 5 minutes Unable to ambulate with or without walking aids for 10 metres