Motor-cognitive Performance in People With Multiple Sclerosis - Brain Activity and Effects of Balance Exercise

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• an MS diagnosis according to McDonald criteria;

• an overall MS-disability score from 2.0 to 5.5 according to the Expanded Disability Status Scale;

• ability to walk 100 m without aid;

• a maximum score of 24 in the Mini-BESTest (i.e., \< 25 points)

• 18 to 65 years of age

Locations
Other Locations
Sweden
Karolinska Institutet
RECRUITING
Stockholm
Contact Information
Primary
Compliance Office Karolinska Institutet
compliance@ki.se
+46852480000
Backup
Erika Franzén, Ph.D
erika.franzen@ki.se
+46852480000
Time Frame
Start Date: 2024-02-26
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 90
Treatments
Experimental: Balance training intervention group
The program HiBalance-MS 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. To ensure highly challenging exercises, each task is individually adjusted, e.g., by altering the base of support, increasing speed, restricting vision and varying grade of multitasking. 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, at Karolinska University Hospital, for an hour, twice a week for 10 weeks, as a group intervention including 6 to 8 participants and facilitated by two physiotherapists/trainers.
No_intervention: No intervention control group
Participants in the control group are encouraged to maintain their normal physical activities and are not restricted from participation in ongoing rehabilitation programs.
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska University Hospital
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov