Motor-cognitive Performance in People With Multiple Sclerosis
NCT06312046, Not applicable, Recruiting, Karolinska Institutet
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Motor-cognitive Performance in People With Multiple Sclerosis | ClinicalTrials.gov |
| NCT number | NCT06312046 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Karolinska Institutet | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis, Postural Balance | ClinicalTrials.gov |
| Interventions | HiBalance-MS | ClinicalTrials.gov |
| First posted | 2024-03-15 | ClinicalTrials.gov |
| Last updated | 2025-07-10 | ClinicalTrials.gov |
Registered outcomes 30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mini Balance Evaluation Systems test. | Pre intervention baseline and post intervention at 10 weeks. | 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. | ClinicalTrials.gov |
| Secondary | 10-Meter Walk Test, maximum speed. | Pre intervention baseline and post intervention at 10 weeks. | Gait performance. Maximum gait speed (meter/second), a higher score indicates higher gait speed. | ClinicalTrials.gov |
| Secondary | 10-Meter Walk Test, self-selected speed. | Pre intervention baseline and post intervention at 10 weeks. | Gait performance. Self-selected comfortable gait speed (meter/second), a higher score indicates higher self-selected comfortable gait speed. | ClinicalTrials.gov |
| Secondary | 2-Minute Walk Test, self-selected speed. | Pre intervention baseline and post intervention at 10 weeks. | Gait performance. Self-selected gait speed (meter/second), a higher score indicates higher self-selected endurance gait speed. | ClinicalTrials.gov |
| Secondary | Gait speed during simultaneous dual task performance. | Pre intervention baseline and post intervention at 10 weeks. | 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, | ClinicalTrials.gov |
| Secondary | Stride length during dual task gait performance. | Pre intervention baseline and post intervention at 10 weeks. | Stride length (meter) during gait 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.Longer stride length indicates better control during walking, | ClinicalTrials.gov |
| Secondary | Step time during dual task gait performance. | Pre intervention baseline and post intervention at 10 weeks. | Step time during gait (seconds) 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. Shorter step time indicates better control during walking, | ClinicalTrials.gov |
| Secondary | Response errors in dual task cognitive performance | Pre intervention baseline and post intervention at 10 weeks. | Dual task cognitive performance during walking will be performed with the Auditory stroop task, a test of cognitive flexibility in selective executive functions. Cognitive performance of the dual task will be assessed as errors in the response (numbers) to the Auditory stroop task. Data colllection is performed through wireless headphones (RazerTM ManO'War) using Audacity software (version 3.0.2). | ClinicalTrials.gov |
| Secondary | Reaction time in dual task cognitive performance | Pre intervention baseline and post intervention at 10 weeks. | Dual task cognitive performance during walking will be performed with the Auditory stroop task, a test of cognitive flexibility in selective executive functions. Cognitive performance of the dual task will be assessed as reaction time (seconds) in the Auditory stroop task. Data colllection is performed through wireless headphones (RazerTM ManO'War) using Audacity software (version 3.0.2). | ClinicalTrials.gov |
| Secondary | Six-Spot Step Test. | Pre intervention baseline and post intervention at 10 weeks. | A test of complex walking. The Six-Spot Step Test is a 5 meter test-field criss-cross walk pattern where the subject while walking is simultaneously kicking wooden blocks from marked circles in the field. Mean time (seconds) of four trials is calculated, shorter time indicates better complex walking performance. | ClinicalTrials.gov |
| Secondary | Completion time in the Trail Making Test. | Pre intervention baseline and post intervention at 10 weeks. | The Trail Making Test (from Delis-Kaplan Executive Function System) assesses attention and psychomotor processing speed. The time (seconds) to complete the test, connecting numbers and letters correctly, is registered. Shorter completion time indicates better attention and higher psychomotor processing speed. | ClinicalTrials.gov |
| Secondary | Number of errors in the Trail Making Test. | Pre intervention baseline and post intervention at 10 weeks. | The Trail Making Test (from Delis-Kaplan Executive Function System) assesses attention and psychomotor processing speed. The number of mistakes/errors is registered. Less number of mistakes/errors indicates better attention and higher psychomotor processing speed. | ClinicalTrials.gov |
| Secondary | Immediate and delayed recall in the Ray Auditory Verbal Learning Test. | Pre intervention baseline and post intervention at 10 weeks. | The Ray Auditory Verbal Learning Test assesses episodic memory. In this test 15 words is repeatedly (five times) read for the subject. The subject is asked to recall as many as possible. The subject is asked again after 30 minutes to recall as many words as possible. The test assesses immediate recall (number) and delayed recall (number) of words where higher number of immediate and delayed recalled words indicates better episodic memory. | ClinicalTrials.gov |
| Secondary | Cognitive processing speed in the Symbol Digit Modalities Test. | Pre intervention baseline and post intervention at 10 weeks. | The Symbol Digit Modalities Test assesses cognitive processing speed. The subject is asked to pair specific numbers with given symbols. The number of correctly paired numbers and symbols within 90 seconds is registered where a higher number indicates higher cognitive processing speed. | ClinicalTrials.gov |
| Secondary | Cognitive function - composite measure of three cognitive tests. | Pre intervention baseline and post intervention at 10 weeks. | Cognitive function will also be assessed as a composite measure of a cognitive test battery consisting of: Trail making Test (from Delis-Kaplan Executive Function System), testing attention and and psychomotor processing speed); Ray Auditory Verbal Learning Test, assessment of episodic memory; and Symbol Digit Modalities Test, assessment of cognitive processing speed. First, the scores of each of the three tests will be standardised into z-scores using pre-scores. Models using different test are compared. The model including all three tests and using the robust diagonally weighted least square estimation will be chosen based on fit values. Last, the z-scores of each test and person are multiplied with the factor loadings and added together to create a sum score for each person and time point. A higher value = greater executive functions. | ClinicalTrials.gov |
| Secondary | Physical activity level. | Pre-and-post-intervention over four to seven days when awake. | Assessment with accelerometer Actigraph GT3X+. Participants wear the accelerometer around the hip, attached slightly above the iliac crest with an elastic band. They wear the accelerometer in their daily life for seven consecutive days (minimum four days), only removing it when showering, bathing, swimming, and at night. As a proxy for the level of daily physical activity, the number of steps per day will be used, where a higher number indicates higher level of physical activity. | ClinicalTrials.gov |
| Secondary | Physical activity level, self-reported. | Pre intervention baseline and post intervention at 10 weeks. | Frändin \& Grimby Scale, a self-reported questionnaire (score 1-6, higher score = higher physical activity level measured in hours, | ClinicalTrials.gov |
| Secondary | Physical exercise habits, self-reported. | Pre intervention baseline and post intervention at 10 weeks. | A question regarding physical exercise habits is included (from The Swedish Research Council). Score 1-6, A higher score indicates larger interval of minutes per week used for physical exercise. | ClinicalTrials.gov |
| Secondary | The generic Walk-12 questionnaire. | Pre intervention baseline and post intervention at 10 weeks. | Self assessment of walking ability with the generic Walk-12 questionnaire. A total of 12 questions, possibility to score from 1 to 5. Total score between12 and 60. A higher score indicates perceived more limited walking ability. | ClinicalTrials.gov |
| Secondary | Falls Efficacy Scale - International. | Pre intervention baseline and post intervention at 10 weeks. | A self-reported questionnaire regarding falls efficacy, A total of 16 questions, score 1-4. Total score from 16 to 64 points, a higher total score = more concerned of falling. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)