None listed
Conditions
Brief summary
Parkinson's disease (PD) is a progressive movement disorder that results in a number of cardinal features; resting tremor, progressive slowness of movement and muscle rigidity. Additionally, and perhaps most debilitating, is postural instability, which generally worsens as the disease progresses. Postural instability is known to affect both static and dynamic balance, and is a contributing factor to falls and near-fall related events. Previous literature has suggested a high incidence of falls in PD (with some reporting a 69% falls rate), which often leads to injuries and the need for hospital admission and/or physical rehabilitation. Although medication is the first point of therapy following diagnosis, such pharmacological therapies do little to preserve or improve postural control. Furthermore, many physical therapies (i.e. physiotherapy) often require on-site participation and exercise prescription to be effective, which is not suitable for people who live in rural areas, and often leads to high drop-out rates. Therefore, there is a need for the exploration of efficacious, non-pharmacotherapeutic methods to improve balance of people with PD from within a home setting to enhance compliance rates. As such, using a single randomised controlled intervention, this project aims to investigate the effects of combining virtual reality exercise gaming (exergaming) with a mobile neurological stimulation technique (transcranial direct current stimulation [tDCS]) to improve the balance, cognition and brain function of people with PD in order to reduce the risk of falls and to enhance exercise adherence.
Interventions
This project aims to investigate the effects of combining virtual reality (VR) exercise gaming (exergaming) with a non-invasive brain stimulation technique (transcranial direct current stimulation [tDCS]) to improve the balance, cognition and brain function of people with Parkinson's disease (PD). There is a 6 month research trial that includes 3 months of exergaming with a follow-up testing session conducted a further 3 months after completion of the trial. All participants will be randomly all
This project aims to investigate the effects of combining virtual reality (VR) exercise gaming (exergaming) with a non-invasive brain stimulation technique (transcranial direct current stimulation [tDCS]) to improve the balance, cognition and brain function of people with Parkinson's disease (PD). There is a 6 month research trial that includes 3 months of exergaming with a follow-up testing session conducted a further 3 months after completion of the trial. All participants will be randomly allocated to one of three groups, with two exergaming groups receiving either real or sham tDCS, and one standard care group. Each exergaming session will last for approximately 40 mins, and will be conducted one-on-one with an experienced clinical exercise therapist at Deakin University's clinical exercise laboratory 2 times per week (24 training sessions altogether). Exergaming will consist of simple balance and dual tasking games designed to improve physical function, balance and cognition using a specially designed VR training program. Adherence to the intervention will be monitored using attendance records. For real tDCS, electrodes placed on the scalp will pass a low-intensity current at 2mA while the participants play the games. For sham tDCS, the device will only provide low-intensity stimulation for 30s before gradually lowering back to zero stimulation. The testing sessions will last approximately 2hours. Each session consists of a series of static and dynamic balance routines designed to test stability and postural control. Cognitive testing will last approximately 30mins and consist of two validated tasks designed to measure executive function in PD. Additionally, near-infrared spectroscopy (NIRS) will be applied during these tests to measure changes in blood flow of the brain; indicative of brain activation. Finally, brain and spinal excitability, will be tested using transcranial magnetic stimulation (TMS), lasting approximately 30mins. TMS passes a painless electromagnetic pulse through the scalp, inducing a light involuntary contraction of a targeted muscle. For this project we will be targeting muscles of the lower leg, which play a critical role in maintaining upright stance in PD. The level of involuntary activation of these muscles is recorded via EMG surface electrodes as a motor evoked potential (MEP). Differences in MEP sizes from pre to post intervention are indicative of improved brain and spinal excitability.
Sponsors
Wei Peng Teo
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Score a minimum of 18 points on the mini mental state examination (MMSE) 2. Complete a general medical questionnaire to ensure no other health complications are present 3. Complete a TMS safety screening questionnaire to ensure no contraindications to TMS are present 4. Provide a statement to declare if they have been diagnosed with PD by a independent neurologist 5. Have a history of 1 or more falls in the last 24 months 6. Present with moderate to severe disease severity as indicated by the Hoehn and Yahr Scale 7. Be on a stable drug regime 8. Not be undertaking physical therapy or strength training for a minimum of 12 months
Exclusion criteria
1) Early stage of PD (UPDRS) 2) Severe lower-limb motor impairments (i.e. requires a walking support or wheelchair bound) 3) Previously diagnosed with stroke or dementia 4) Metal implants in the participants head (i.e. deep brain stimulator or aneurysm clips) 5) Other medical conditions or physical disabilities interfering with the participant’s mobility
Outcome results
None listed