Clinical trial NCT05710588: The Effectiveness of Motor-motor and Motor-cognitive Dual-task Training Interventions on Balance in People With Parkinson's Disease: a Feasibility Study
Official title: The Effectiveness of Motor-motor and Motor-cognitive Dual-task Training Interventions on Balance in People With Parkinson's Disease: a Feasibility Study of a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
balance
dual-task training
home-based training
feasibility
acceptability
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two different intervention groups: M-DTT and C-DTT. Participants will be allocated to either M-DTT or C-DTT group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

* To test the feasibility and acceptability of home-based C-DTT and M-DTT interventions.
* To assess the acceptability and utility of the outcome measures, from the participant perspective.
* To assess safety by monitoring for any adverse events or serious adverse events.
* To assess the feasibility and acceptability of the safety monitoring process, from the participant perspective.
* To assess the potential effect of C-DTT and M-DTT on standing and walking balance.

Eligibility criteria: Inclusion Criteria:

* Self-report a diagnosis of PD
* Are categorized as having mild to moderate PD (based on scoring of the modified UPDRS scale, undertaken via an online interview).
* Can understand and follow instructions.
* Can independently, or with help of a supporter, complete self-report outcome measures.
* Can use web-based/online applications independently, or with help of a supporter.
* Have a supporter (carer, spouse, family member aged ≥18) who is willing and able to act as an exercise buddy.
* Have an available safe training area according to the definition: A 2 meter square clear area immediately next to a wall, with no trip hazards and with the potential to place a chair within the space (for seated rests). The wall needs to be free from hanging objects or shelves and not wallpapered or featuring flaking plaster. This is to ensure safety during training and prevent unintended damage to the wall. (Closed doors may be considered as part of the 'wall' only if they can be securely shut, so that should a near-fall occur with participant's falling against the door, they would not open. They should also be guaranteed not to be opened by other household members (including pets) during the training session (which could potentially cause a fall)).

Exclusion Criteria:

* Neurological, orthopaedic or any other current medical problems other than PD which can affect standing balance (such as stroke, cerebellar disorders, a vestibular impairment, a skeletal fracture (occurred within past six months), severe visual impairment) as this could both risk safety within a standardized training protocol and independently affect treatment outcomes.
* Severe deafness without the support of a signing translator, to ensure that participants will be able to effectively receive communication.
* Those unable to communicate in English, as no translation will be available, and communication is essential in ensuring safety.
* Unable to stand independently for more than 1 minute without requiring external postural support, to ensure safety (and prevent falls) during training and outcome measurement.
* Unsuitable training area according to the definition.

Primary outcomes:
measure: change from baseline body sway at 6 weeks
timeFrame: Measurements will be conducted at baseline and after the 6-weeks training programme.
measure: change from baseline MiniBESTest score at 6 weeks
timeFrame: Measurements will be conducted at baseline and after the 6-weeks training programme. Higher scores represent better outcome
measure: Acceptability questionnaire
timeFrame: at the end of week 2 of the training programme.
measure: Acceptability questionnaire
timeFrame: at the end of week 4 of the training programme.
measure: Acceptability questionnaire
timeFrame: at the end of week 6 of the training programme.
measure: the number of total hours of undertaken training sessions over 6 weeks training programme
timeFrame: at the end of the 6 weeks training programme
measure: semi-structured interviews
timeFrame: a week after completion of the training programme
measure: safety assessment by monitoring for any adverse events
timeFrame: at the end of the 6 weeks training programme.
Secondary outcomes:
Other outcomes:
measure: Demographic and medical information form
timeFrame: At baseline
measure: self-report MDS-UPDRS-II questionnaire
timeFrame: At baseline
measure: Mini Mental State Examination Test
timeFrame: At baseline
Locations:
city: Plymouth
country: United Kingdom
facility: University of Plymouth
Study officials:
affiliation: University of Plymouth
name: Lisa Bunn
role: STUDY_DIRECTOR
References:
citation: De Freitas TB MS, PT, Leite PHW BS, Dona F PhD, PT, Pompeu JE PhD, PT, Swarowsky A PhD, PT, Torriani-Pasin C PhD, PT. The effects of dual task gait and balance training in Parkinson's disease: a systematic review. Physiother Theory Pract. 2020 Oct;36(10):1088-1096. doi: 10.1080/09593985.2018.1551455. Epub 2018 Dec 3.
citation: Hasegawa N, Shah VV, Harker G, Carlson-Kuhta P, Nutt JG, Lapidus JA, Jung SH, Barlow N, King LA, Horak FB, Mancini M. Responsiveness of Objective vs. Clinical Balance Domain Outcomes for Exercise Intervention in Parkinson's Disease. Front Neurol. 2020 Sep 25;11:940. doi: 10.3389/fneur.2020.00940. eCollection 2020.
citation: Li Z, Wang T, Liu H, Jiang Y, Wang Z, Zhuang J. Dual-task training on gait, motor symptoms, and balance in patients with Parkinson's disease: a systematic review and meta-analysis. Clin Rehabil. 2020 Nov;34(11):1355-1367. doi: 10.1177/0269215520941142. Epub 2020 Jul 13.
citation: Pourkhani, T., Daneshmandi, H., Norasteh, A., Bakhshayesh Eghbali, B. & Sedaghati, P. (2019) 'The Effect of Cognitive and Motor Dual-Task Training on Improvement of Balance and Some Spatiotemporal Gait Parameters in People With Idiopathic Parkinson Disease.'. Caspian J Neurol Sci., 5 (4), pp. 190-198.
citation: Radder DLM, Ligia Silva de Lima A, Domingos J, Keus SHJ, van Nimwegen M, Bloem BR, de Vries NM. Physiotherapy in Parkinson's Disease: A Meta-Analysis of Present Treatment Modalities. Neurorehabil Neural Repair. 2020 Oct;34(10):871-880. doi: 10.1177/1545968320952799. Epub 2020 Sep 11.
citation: Vallabhajosula S, McMillion AK, Freund JE. The effects of exergaming and treadmill training on gait, balance, and cognition in a person with Parkinson's disease: A case study. Physiother Theory Pract. 2017 Dec;33(12):920-931. doi: 10.1080/09593985.2017.1359867. Epub 2017 Aug 16.
citation: Vellata C, Belli S, Balsamo F, Giordano A, Colombo R, Maggioni G. Effectiveness of Telerehabilitation on Motor Impairments, Non-motor Symptoms and Compliance in Patients With Parkinson's Disease: A Systematic Review. Front Neurol. 2021 Aug 26;12:627999. doi: 10.3389/fneur.2021.627999. eCollection 2021.