An interventional study of motor-motor dual-task training and motor-cognitive dual-task training in Parkinson's Disease, sponsored by University of Plymouth. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by University of Plymouth · Not applicable, Interventional, and Treatment
This study aims to test the feasibility and acceptability of home-based motor-motor dual-task training and motor-cognitive dual-task training interventions, and balance-related outcome measures which may be used in an anticipated future randomized control trial intended to determine the superiority of these dual-task training interventions.
Parkinson's disease (PD) is a complex, progressive neurodegenerative disorder characterized by the degeneration of dopaminergic neurons in the basal ganglia. Balance impairment is one of the major problems in people with PD, often manifested at a stage of mild to moderate disease severity.
Balance impairments in people with PD affect different domains of balance control: (1) postural sway during quiet stance, (2) automatic postural responses to external perturbations, (3) anticipatory postural adjustment, such as is seen before gait initiation (APAs), and (4) dynamic balance during walking. Therefore, it is important to focus on upright, bipedal balance in people with PD.
Physiotherapy approaches have found to be effective in improving balance-related motor impairments in people with PD. Dual-task training is one of these physiotherapy approaches. This involves simultaneous performance of a primary task and a second discrete task which is independent from the primary task. The primary task is usually a motor task like standing or walking, and the secondary task is either a motor task or a cognitive task such as carrying an object or talking. Dual-task training (DTT) has demonstrated to be effective in enhancing balance control and promoting interactions between the motor and cognitive systems. Two systematic reviews have been undertaken in this area. One found DTT improved balance in people with mild to moderate PD. The second included a meta-analysis, reporting a moderate effect in favor of DTT group on functional balance. However, there remains a lack of evidence about the superiority of motor-motor dual-task training (M-DTT) versus motor-cognitive dual-task training (C-DTT) in terms of improving balance.
A scoping review which is a part of this project shows that only one study compares the effectiveness of M-DTT and C-DTT on balance but this study has some methodological limitations. So, there is a need for a future randomized control trial to investigate the superiority of M-DTT and C-DTT on balance in people with PD.
The COVID-19 pandemic has shifted physiotherapy deliveries to telerehabilitation . A recent systematic review showed that telerehabilitation is feasible for people with PD and effective in improving and/or maintaining balance and gait and some non-motor aspects (quality of life, patient satisfaction) of the disease. So, DTT delivered to people in their homes via telerehabilitation may be an applicable alternative to traditional face-to-face physiotherapy service delivery.
The scoping review showed that there is some published evidence about home-based DTT, but no studies have investigated and compared the effectiveness of M-DTT and C-DTT interventions on balance in people with mild-moderate PD. For instance, one case study used C-DTT as a part of exergaming plus treadmill intervention in a home setting, but they only applied C-DTT, and there was no other type of DTT as a comparison in their study.
So, this study aims to test the feasibility and acceptability of the M-DTT and C-DTT interventions, and balance-related outcome measures which may be used in an anticipated future randomized control study intended to determine the superiority of these dual-task training interventions.
Study Objectives:
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Plymouth is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group has motor-motor dual task training-balance related tasks as primary task (e.g. marching, stepping) and motor tasks as secondary task (e.g. touching wall, popping a fidget toy).
Other: motor-motor dual-task training
This group has motor-cognitive dual-task training-balance related tasks as primary task (e.g. marching, stepping) and cognitive tasks as secondary task (e.g. repeating tongue twisters, counting backwards from 100).
Other: motor-cognitive dual-task training
The intervention compromises balance-related tasks which are selected among the tasks often used in balance rehabilitation and motor secondary tasks might be required hand dexterity like popping a fidget toy or reaching ability like touching wall. All sessions will be individual. The initial training session will be undertaken in University of Plymouth. This will be followed by a recorded training video programme which can be accessible through Panopto- a University-led, web-based platform- undertaken in the participants' home for 30 minute sessions, three times a week over 6 weeks.
The intervention compromises (1) balance-related tasks which are selected among the tasks often used in balance rehabilitation and (2) cognitive secondary tasks might required to activate sensory and cognitive systems like listening podcast and memorizing the details about it or reading a tongue twister and repeating. intervention delivery will be the same with M-DTT group.
change from baseline body sway at 6 weeks
body sway will be recorded for mediolateral (ML) and anteroposterior (AP) directions. A sensor will calculate the orientation euler angles (XYZ Earth fixed type) in degrees. Measurements will be standing 45 sec in comfortable position-eyes open, comfortable position-eyes closed, and feet are in 4 cm apart-eyes open on firm surface.
Time frame: Measurements will be conducted at baseline and after the 6-weeks training programme.
change from baseline MiniBESTest score at 6 weeks
standing and functional balance assessment
Time frame: Measurements will be conducted at baseline and after the 6-weeks training programme. Higher scores represent better outcome
Acceptability questionnaire
Participants' perception regarding the intervention (individual task difficulty, progression, satisfaction, enjoyment, etc.), will be asked via an online 5-point Likert scale questionnaire.
Time frame: at the end of week 2 of the training programme.
Acceptability questionnaire
Participants' perception regarding the intervention (individual task difficulty, progression, satisfaction, enjoyment, etc.), will be asked via an online 5-point Likert scale questionnaire.
Time frame: at the end of week 4 of the training programme.
Acceptability questionnaire
Participants' perception regarding the intervention (individual task difficulty, progression, satisfaction, enjoyment, etc.), will be asked via an online 5-point Likert scale questionnaire.
Time frame: at the end of week 6 of the training programme.
the number of total hours of undertaken training sessions over 6 weeks training programme
Panopto (University of Plymouth licensed online video streaming platform) enables to record participants adherence and attendance rates to the training sessions. the number of hours watched will be recorded for each session and for 6 weeks training programme in total.
Time frame: at the end of the 6 weeks training programme
semi-structured interviews
to assess acceptability their perception regarding outcome measures (trustfulness, etc.), monitoring (e.g. difficulty, independence, etc.), and overall intervention will be asked in an online semi-structured interviews.
Time frame: a week after completion of the training programme
safety assessment by monitoring for any adverse events
for safety assessment the number of falls and near falls (stumbling/losing balance not resulting with a fall) during the training programme will be recorded within training workbook by participants. Semi-structured interviews will allow to understand how those falls/near falls occured. Also, any serious adverse events that resulted any injuries will be asked during this interviews.
Time frame: at the end of the 6 weeks training programme.
Demographic and medical information form
Age, gender, number of years after diagnosis, working status, other medical conditions, the number of falls in last month.
Time frame: At baseline
self-report MDS-UPDRS-II questionnaire
This questionnaire asks questions how Parkinson's affects patients' experiences of daily life to understand their disease severity. Higher scores represent higher severity.
Time frame: At baseline
Mini Mental State Examination Test
A test of cognitive function. Higher scores represent better cognitive function.
Time frame: At baseline
Plan to share: No — The information from participants and all collected and processed data will be used only for the purpose of this study by the research team. University of Plymouth will keep data about participants for 10 years after the study has finished and then will destroy the data permanently.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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