Evidence map›Paper›PMID 39242508›Full record

ArticleTrials2024

Effect of a soft exosuit on daily life gait performance in people with incomplete spinal cord injury: study protocol for a randomized controlled trial.

L Visch, B E Groen, A C H Geurts, I J W van Nes, N L W Keijsers

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05605912 (Efficacy of the Myosuit for Increasing Daily Life Gait Performance in the Home and Community Setting and Gait Capacity in People With Incomplete Spinal Cord Injury), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05605912 nacompletednot on this map

Efficacy of the Myosuit for Increasing Daily Life Gait Performance in the Home and Community Setting and Gait Capacity in People With Incomplete Spinal Cord Injury

TypeinterventionalSponsorSint MaartenskliniekRan2022 to 2025Enrolled34ConditionsIncomplete Spinal Cord InjuryArmsControl, Myosuit
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

L VischDepartment of Research, Sint Maartenskliniek, Nijmegen, The Netherlands. la.visch@maartenskliniek.nl.
B E GroenDepartment of Research, Sint Maartenskliniek, Nijmegen, The Netherlands.
A C H GeurtsDepartment of Rehabilitation, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands.
I J W van NesDepartment of Rehabilitation, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands.
N L W KeijsersDepartment of Research, Sint Maartenskliniek, Nijmegen, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeople with incomplete spinal cord injury (iSCI) often have gait impairments that negatively affect daily life gait performance (i.e., ambulation in the home and community setting) and quality of life. They may benefit from light-weight lower extremity exosuits that assist in walking, such as the Myosuit (MyoSwiss AG, Zurich, Switzerland). A previous pilot study showed that participants with various gait disorders increased their gait speed with the Myosuit in a standardized environment. However, the effect of a soft exosuit on daily life gait performance in people with iSCI has not yet been evaluated.

objectiveThe primary study objective is to test the effect of a soft exosuit (Myosuit) on daily life gait performance in people with iSCI. Second, the effect of Myosuit use on gait capacity and the usability of the Myosuit in the home and community setting will be investigated. Finally, short-term impact on both costs and effects will be evaluated.

methodsThis is a two-armed, open label, randomized controlled trial (RCT). Participants will be randomized (1:1) to the intervention group (receiving the Myosuit program) or control group (initially receiving the conventional program). Thirty-four people with chronic iSCI will be included. The Myosuit program consists of five gait training sessions with the Myosuit at the Sint Maartenskliniek. Thereafter, participants will have access to the Myosuit for home use during 6 weeks. The conventional program consists of four gait training sessions, followed by a 6-week home period. After completing the conventional program, participants in the control group will subsequently receive the Myosuit program. The primary outcome is walking time per day as assessed with an activity monitor at baseline and during the first, third, and sixth week of the home periods. Secondary outcomes are gait capacity (10MWT, 6MWT, and SCI-FAP), usability (D-SUS and D-QUEST questionnaires), and costs and effects (EQ-5D-5L). DISCUSSION: This is the first RCT to investigate the effect of the Myosuit on daily life gait performance in people with iSCI.

trial registrationClinicaltrials.gov NCT05605912. Registered on November 2, 2022.

Indexed as

GaitRandomized Controlled Trials as TopicSpinal Cord InjuriesActivities of Daily LivingAdultBiomechanical PhenomenaCost-Benefit AnalysisEquipment DesignExoskeleton DeviceFemaleGait Disorders, NeurologicHealth Care CostsHumansMaleMiddle AgedQuality of LifeAmbulationExosuitGaitHome and community settingIncomplete spinal cord injury

Identifiers

PMID39242508
PMCPMC11378477

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.