Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312046
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-04
Brief Title:
Motor-cognitive Performance in People With Multiple Sclerosis
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Motor-cognitive Performance in People With Multiple Sclerosis - Brain Activity and Effects of Balance Exercise
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HiBalance-MS
Brief Summary:
Having a neurological disease such as multiple sclerosis MS leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks hindering activity performance and influencing the possibilities for an independent lifestyle
The investigators have adapted a previously developed balance training program to a highly challenging program specifically directed to MS HiBalance-MS This program was recently tested and found feasible in a pilot study The investigators will now perform a randomized controlled trial in people with MS in order to determine the effects of the program The hypothesis is that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control walking motor-cognitive performance activity performance and health related quality of life
The investigators have adapted a previously developed balance training program to a highly challenging program specifically directed to MS HiBalance-MS This program was recently tested and found feasible in a pilot study The investigators will now perform a randomized controlled trial in people with MS in order to determine the effects of the program The hypothesis is that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control walking motor-cognitive performance activity performance and health related quality of life
Detailed Description:
Everyday living means being in complex environments and performing complex activities which usually consist of and require a combination of motor and cognitive skills Having a neurological disease such as multiple sclerosis MS compromises the motor-cognitive performance This leads to difficulties in balance and gait with or without concurrent performance of cognitive tasks hindering activity performance and influencing the possibilities for an independent lifestyle
The investigators have in a co-design process with stakeholders adapted a HiBalance program originally developed by the Franzén research group for people with Parkinsons disease and combining motor-cognitive exercises in a progressively more difficult manner HiBalance-PD to a program specifically developed to MS HiBalance-MS The developed HiBalance-MS program was recently tested and found feasible in a pilot study results published 2023 The investigators will now perform a randomized controlled trial in people with MS in order to determine the effects of a highly challenging balance training program HiBalance-MS on physical and cognitive functioning and activity performance in this group The results will have immediate application and clinical relevance With improved balance control people with MS will also gain other health benefits related to an active lifestyle and a better everyday life
The hypothesis that motor-cognitive performance is reduced and impact activity performance in people with MS They also hypothesize that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control walking motor-cognitive performance activity performance and health related quality of life
Participants will be recruited through Karolinska University Hospital through physiotherapists and physicians specialized in neurology in Stockholm and via advertisement in newspapers and the patient organization NEURO Sweden According to earlier power calculations for detecting effects in balance and gait measures after this particular intervention the investigators anticipate 40 to 50 participants in each group to detect significant changes
The HiBalance-MS program is based on scientifically well-established principles of exercise training and postural control It will be conducted as a progressive individually adjusted group training to challenge the specific balance deficit of every participant Four main sub-systems underlying balance control stability limits anticipatory postural adjustments sensory integration and motor agility are used to target specific balance impairments To ensure highly challenging exercises each task is individually adjusted Daily variation in capacity will be rated before each training session and participants will at the end of each session rate the challenging level The training will be performed in the clinic Karolinska University hospital for an hour twice a week for 10 weeks as a group intervention 6 to 8 participants facilitated by two physiotherapiststrainers
The investigators have in a co-design process with stakeholders adapted a HiBalance program originally developed by the Franzén research group for people with Parkinsons disease and combining motor-cognitive exercises in a progressively more difficult manner HiBalance-PD to a program specifically developed to MS HiBalance-MS The developed HiBalance-MS program was recently tested and found feasible in a pilot study results published 2023 The investigators will now perform a randomized controlled trial in people with MS in order to determine the effects of a highly challenging balance training program HiBalance-MS on physical and cognitive functioning and activity performance in this group The results will have immediate application and clinical relevance With improved balance control people with MS will also gain other health benefits related to an active lifestyle and a better everyday life
The hypothesis that motor-cognitive performance is reduced and impact activity performance in people with MS They also hypothesize that progressively challenging balance exercise programs that are specific to the balance control domains affected by MS will be effective to improve balance control walking motor-cognitive performance activity performance and health related quality of life
Participants will be recruited through Karolinska University Hospital through physiotherapists and physicians specialized in neurology in Stockholm and via advertisement in newspapers and the patient organization NEURO Sweden According to earlier power calculations for detecting effects in balance and gait measures after this particular intervention the investigators anticipate 40 to 50 participants in each group to detect significant changes
The HiBalance-MS program is based on scientifically well-established principles of exercise training and postural control It will be conducted as a progressive individually adjusted group training to challenge the specific balance deficit of every participant Four main sub-systems underlying balance control stability limits anticipatory postural adjustments sensory integration and motor agility are used to target specific balance impairments To ensure highly challenging exercises each task is individually adjusted Daily variation in capacity will be rated before each training session and participants will at the end of each session rate the challenging level The training will be performed in the clinic Karolinska University hospital for an hour twice a week for 10 weeks as a group intervention 6 to 8 participants facilitated by two physiotherapiststrainers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None