Parkinson's DiseaseNCT05710588
The Effectiveness of Motor-motor and Motor-cognitive Dual-task Training Interventions on Balance in People With Parkinson's Disease: a Feasibility Study
A study testing motor-motor dual-task training and motor-cognitive dual-task training in people with Parkinson's Disease, run by University of Plymouth at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- motor-motor dual-task training and motor-cognitive dual-task training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2022to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lisa Bunn contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Plymouth
Plymouth, PL4 8AA
Nesibe Cakmak, nesibe.cakmak@plymouth.ac.uk
About this 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
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- motor-motor dual-task training, motor-cognitive dual-task training
- Keywords
- Parkinson's disease, balance, dual-task training, home-based training, feasibility, acceptability
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor-motor dual-task trainingOther
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.
motor-cognitive dual-task trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: motor-cognitive dual-task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the end of the 6 weeks training programme.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start31 Oct 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion10 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesibe Cakmak, University of Plymouth
- Investigators
- Lisa Bunn, Study director, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710588
- Sponsor's protocol ID
- 3332
- Status last verified
- Jan 2023
- First submitted
- 24 Dec 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 30501424Hasegawa 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.
PubMed 33101161Li 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.
PubMed 32660265Pourkhani, 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.
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.
PubMed 32917125Vallabhajosula 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.
PubMed 28812419Vellata 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.
PubMed 34512495
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05710588
- Acronym / sponsor ID
- 3332
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, balance, dual-task training, home-based training, feasibility, acceptability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 10 Apr 2023 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| M-DTT group | Experimental | Other: motor-motor dual-task trainingThis 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). |
| C-DTT group | Experimental | Other: motor-cognitive dual-task trainingThis 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor-motor dual-task trainingThe 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. | Other | M-DTT group |
| motor-cognitive dual-task trainingThe 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. | Other | C-DTT group |
Primary outcome
change from baseline body sway at 6 weeks
Time frame: Measurements will be conducted at baseline and after the 6-weeks training programme.
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.
change from baseline MiniBESTest score at 6 weeks
Time frame: Measurements will be conducted at baseline and after the 6-weeks training programme. Higher scores represent better outcome
standing and functional balance assessment
Acceptability questionnaire
Time frame: at the end of week 2 of the training programme.
Participants' perception regarding the intervention (individual task difficulty, progression, satisfaction, enjoyment, etc.), will be asked via an online 5-point Likert scale questionnaire.
Acceptability questionnaire
Time frame: at the end of week 4 of the training programme.
Participants' perception regarding the intervention (individual task difficulty, progression, satisfaction, enjoyment, etc.), will be asked via an online 5-point Likert scale questionnaire.
Acceptability questionnaire
Time frame: at the end of week 6 of the training programme.
Participants' perception regarding the intervention (individual task difficulty, progression, satisfaction, enjoyment, etc.), will be asked via an online 5-point Likert scale questionnaire.
the number of total hours of undertaken training sessions over 6 weeks training programme
Time frame: at the end of the 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.
semi-structured interviews
Time frame: a week after completion of the training programme
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.
safety assessment by monitoring for any adverse events
Time frame: at the end of the 6 weeks training programme.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 30501424De 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.
- Background: PubMed 33101161Hasegawa 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.
- Background: PubMed 32660265Li 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.
- BackgroundPourkhani, 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: PubMed 32917125Radder 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.
- Background: PubMed 28812419Vallabhajosula 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.
- Background: PubMed 34512495Vellata 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Bunn contact
Lisa Bunn study director
University of Plymouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor-motor dual-task training and motor-cognitive dual-task training in people with Parkinson's Disease, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesibe Cakmak (07474913626 ext. +44, nesibe.cakmak@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline body sway at 6 weeks (time frame: Measurements will be conducted at baseline and after the 6-weeks training programme.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710588, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.