Trial · NCT07897760
Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis
NCT07897760, Not applicable, Not yet recruiting, Otto Bock Healthcare Products GmbH
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis. Trials, record NCT07897760. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07897760
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis
- NCT number
- NCT07897760
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Otto Bock Healthcare Products GmbH
- Conditions
- Multiple Sclerosis
- Interventions
- Electrostimulation suit
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Balance responder rate: Percentage of patients achieving a clinically meaningful improvement in balance, as measured by the Berg Balance Scale (BBS), in the treatment group compared with sham-control group. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | Percentage of patients achieving a clinically meaningful improvement in balance, defined as a ≥6-point improvement from baseline 1 on the Berg Balance Scale (BBS) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The Berg Balance Scale (BBS) is a 14-item clinical assessment designed to evaluate static and dynamic balance during functional tasks. Each item is scored on a 5-point ordinal scale ranging from 0 to 4, with a total score range of 0 to 56. Higher scores indicate better balance performance and lower fall risk, while lower scores indicate greater balance impairment. Points are deducted when a task cannot be completed independently, requires supervision or assistance, or does not meet the specified performance criteria. The BBS assesses balance during activities such as sitting, standing, transferring, reaching, turning, and single-leg stance. |
| Primary | Walking responder rate: Percentage of patients achieving a clinically meaningful improvement in walking ability, on the transformed 0-100 Multiple Sclerosis Walking Scale-12 (MSWS-12), in the treatment group compared with the sham -control group. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | Percentage of patients achieving a clinically meaningful improvement in walking ability, defined as a ≥8-point decrease from baseline 1 on the transformed 0-100 Multi-ple Sclerosis Walking Scale-12 (MSWS-12) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The MSWS-12 is a self-report questionnaire designed to assess the impact of MS on an individual's walking ability. It consists of 12 items, each rated on a scale from 1 to 5, where 1 indicates no limitation, and 5 indicates extreme limitation. The items cover various aspects of walking, e.g.: ability to walk and run, climbing stairs, standing balance, walking distance and speed, effort required for walking. The total score is calculated by summing up the responses, which can then be transformed to a scale from 0 to 100, with higher scores indicating a greater impact on walking ability. |
| Secondary | Walking endurance responder rate: Percentage of patients achieving a clinically meaningful improvement in walking endurance, as measured by the 6-Minute Walk Test (6MWT), in the treatment group compared with the sham-control group. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | Percentage of patients achieving a clinically meaningful improvement in walking endurance, defined as a ≥19.7-meter increase from baseline 1 on the 6-Minute Walk Test (6MWT) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The 6-minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endur-ance. The subject is asked to walk as far as possible for 6 minutes on a predefined track. The dis-tance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. |
| Secondary | MS impact responder rate: Percentage of patients achieving a clinically meaningful improvement in the impact of multiple sclerosis on daily life, as measured by the MSIS-29, in the treatment group compared with the sham-control group. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | Percentage of patients achieving a clinically meaningful improvement in the impact of multiple sclerosis on daily life, defined as a ≥9.1-point decrease from baseline 1 on the Physical subscale and a ≥5.5-point decrease from base-line 1 on the Psychological subscale of the Multiple Sclerosis Impact Scale-29 (MSIS-29) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. MSIS-29 is a self-report questionnaire designed to measure the impact of Multiple Sclerosis (MS) on a person's daily life. It consists of 29 items divided into two subscales: physical impact (20 items) and psychological impact (9 items). Each item is rated on a scale from 1 (not at all) to 5 (extremely), reflecting the extent to which MS affects various aspects of daily functioning. The scores for each subscale are summed and then transformed to a 0-100 scale, with higher scores indicating a greater impact of MS |
| Secondary | Health-related quality-of-life responder rate: Percentage of patients achieving a clinically meaningful improvement in health-related quality of life, as measured by the EQ-5D-5L Utility Index, in the treatment group compared with the sham-control group. | From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days). | Percentage of patients achieving a clinically meaningful improve-ment in health-related quality of life, defined as an improvement from baseline 1 in the EQ-5D-5L Utility Index meeting or exceed-ing the subtype-specific minimal important change (MIC) thresh-old after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The EQ-5D-5L is a standardized measure of health-related quality of life consisting of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale ranging from no problems to extreme problems. Responses are combined into a health state that can be converted into a utility index score from less than 0 (worse than death) to 1 (perfect quality of live), with higher scores indicating better health-related quality of life. The EQ-5D-5L also includes a visual analogue scale (EQ VAS) ranging from 0 to 100, with higher scores better. |
| Other | Walking ability as measured by Timed 25-Foot Walk Test (T25FW) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | The T25FW measures walking speed. Individuals are instructed to walk 25 feet as quickly and safely as possible, with the time recorded. Faster times indicate better mobility and gait function. It is widely used in MS clinical studies to assess ambulatory performance. |
| Other | Mobility and dynamic balance as measured by Six Spot Step Test (SSST) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | The Six Spot Step Test (SSST) is a performance-based measure of walking ability, agility, and lower-extremity motor control. During the test, participants walk along a designated path while moving six objects from marked circles using their feet. The outcome is the time required to complete the task, measured in seconds. Lower times indicate better performance, whereas higher times indicate greater impairment in walking and coordination. |
| Other | Finger dexterity as measured by 9-Hole Peg Test (9HPT) | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | The 9-Hole Peg Test (9HPT) is a standardized measure of fine motor function and manual dexterity of the upper extremities. During the test, participants place nine pegs into nine holes and then remove them as quickly as possible. The outcome is the time required to complete the task, measured in seconds. Lower times indicate better manual dexterity, whereas higher times indicate greater impairment of hand function. |
| Other | Perceived physical impact of multiple sclerosis on a patient's daily life, as measured by the MSIS-29 Physical Impact Subscale | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | The Multiple Sclerosis Impact Scale - 29 Physical Impact Subscale (MSIS-29 PHYS) is a patient-reported measure of the physical impact of multiple sclerosis on daily life. The subscale comprises 20 items evaluating limitations in physical functioning. The total score ranges from 20 to 100, with higher scores indicating greater physical impact of multiple sclerosis and worse physical functioning, and lower scores indicating less physical impact and better physical functioning. |
| Other | Perceived psychological impact of multiple sclerosis on a patient's daily life, as measured by the MSIS-29 Psychological Impact Sub-scale | Change from Baseline 1 at two post-baseline time points-after a single stimulation and after 28 days (-3/+10 days) | The Multiple Sclerosis Impact Scale - 29 Psychological Impact Subscale (MSIS-29 PSYCH) is a patient-reported measure of the psychological impact of multiple sclerosis on daily life. The subscale comprises 9 items evaluating aspects such as emotional well-being, anxiety, and depression. The total score ranges from 9 to 45, with higher scores indicating greater psychological impact of multiple sclerosis and poorer psychological well-being, and lower scores indicating less psychological impact and better psychological well-being. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT07897760/registered