The Effectiveness of Motor-motor and Motor-cognitive Dual-task Training Interventions on Balance in People With Parkinson's Disease: a Feasibility Study

NCT05710588 | Unknown

• 1 other identifier: 3332
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; balance; dual-task training; home-based training; feasibility; acceptability

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  at the end of the 6 weeks training programme.

Other Outcomes (3)

• Demographic and medical information form

  At baseline

• self-report MDS-UPDRS-II questionnaire

  At baseline

• Mini Mental State Examination Test

  At baseline

Study Arms (2)

M-DTT group

EXPERIMENTAL

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

C-DTT group

EXPERIMENTAL

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

Interventions

motor-motor dual-task training OTHER

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.

M-DTT group

motor-cognitive dual-task training OTHER

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.

C-DTT group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (1)

University of Plymouth

Plymouth, PL4 8AA, United Kingdom

RECRUITING

Related Publications (7)

• 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.

  PMID: 30501424 BACKGROUND

• 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.

  PMID: 33101161 BACKGROUND

• 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.

  PMID: 32660265 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32917125 BACKGROUND

• 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.

  PMID: 28812419 BACKGROUND

• 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.

  PMID: 34512495 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Lisa Bunn

  University of Plymouth

  STUDY DIRECTOR

Central Study Contacts

Nesibe Cakmak

CONTACT

07474913626; nesibe.cakmak@plymouth.ac.uk

Lisa Bunn

CONTACT

lisa.bunn@plymouth.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will know they are allocated to one group randomly but they will not know which group is this.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are two different intervention groups: M-DTT and C-DTT. Participants will be allocated to either M-DTT or C-DTT group.

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: February 2, 2023
• Study Start: October 31, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 10, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)