Motor-cognitive Performance in People With Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKarolinska Institutet
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
cognitive impairment as indicated by a score <21 in the Montreal Cognitive Assessment;
presence of other conditions that would substantially influence balance;
an MS relapse or change of disease-modifying treatment within the past 8 weeks
Trial design
Design model
Parallel
Treatments tested in this trial
HiBalance-MS
Other interventionSee arm description for intervention group.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Balance training intervention groupExperimental treatment 1 intervention
Group B: No intervention control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mini Balance Evaluation Systems test.
Balance performance. A rating scale for dynamic balance incorporating 14 different balance and gait items that are assessed by a physical therapist on a scale from 0-2. Points between 0 and 28; a higher total score indicates better balance control.
Time frame
Pre intervention baseline and post intervention at 10 weeks.Secondary outcomes
1
10-Meter Walk Test, maximum speed.
Gait performance. Maximum gait speed (meter/second), a higher score indicates higher gait speed.
Time frame
Pre intervention baseline and post intervention at 10 weeks.2
10-Meter Walk Test, self-selected speed.
Gait performance. Self-selected comfortable gait speed (meter/second), a higher score indicates higher self-selected comfortable gait speed.
Time frame
Pre intervention baseline and post intervention at 10 weeks.3
2-Minute Walk Test, self-selected speed.
Gait performance. Self-selected gait speed (meter/second), a higher score indicates higher self-selected endurance gait speed.
Time frame
Pre intervention baseline and post intervention at 10 weeks.4
Gait speed during simultaneous dual task performance.
Gait speed (meter/second), will be analyzed during dual task walking with the Ambulatory Parkinson´s Disease Monitoring (APDM) mobility Lab system. Dual tasking during walking will be performed with the Auditory stroop task, a test of cognitive function, see below. A higher score indicates higher gait speed during dual tasking,
Time frame
Pre intervention baseline and post intervention at 10 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov