Trial reportBMJ open2026
Home-based exoskeleton use to improve quality of life in patients with multiple sclerosis: study protocol of a multicentre, randomised, cross-over trial.
Trial report in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05835622 (Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients With Gait Disorders.), which is not on this map. Not yet cited in PubMed.
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.
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.
Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients With Gait Disorders.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMultiple sclerosis (MS) frequently leads to mobility impairment, fatigue and a significant decline in health-related quality of life (QoL). Home-based assistive technology, such as robotic exoskeletons, offers a promising solution to enhance independent mobility and increase the intensity of motor training. Long-term functional and quality of life benefits of light lower-limb exoskeleton home use have yet to be determined.
objectiveThe primary objective of this study is to determine the efficacy of an 8-week period, home-based use of a robotic exoskeleton in improving QoL in individuals with MS, compared with a no-device control period.
methodsThis is a multicentre, randomised, controlled and single-blinded cross-over trial. A total of 28 patients with confirmed MS (Expanded Disability Status Scale (EDSS) score 5.0-7.0) will be recruited across three rehabilitation centres. Participants will be randomly assigned to two 8-week phases: intervention (daily home-based exoskeleton use) or control (physical activity advice), separated by an 8-week wash-out period. The primary outcome is the change in the MS Quality of Life assessed by the Functional Assessment of Multiple Sclerosis (FAMS) physical composite score from baseline to the end of each phase. Secondary outcomes include changes in walking performance (2-minute Walk, 10 M Walk, Timed Up-and-Go, Four Square Step Test and Sit-to-Stand Test), fatigue severity (Fatigue Severity Scale and Fatigue Impact Measurement Scale (EMIF)-MS), and strength capacity (Manual Muscle Testing, Tardieu scale), self-confidence (Rosenberg), anxiety and depression (Hospital Anxiety and Depression Scale), satisfaction to use (Technical Aid Satisfaction Scale) and intention to use (Unified Theory of Acceptance and Use of Technology). ETHICS AND DISSEMINATION: This study was registered on ClinicalTrials.gov on 1 February 2024 (Trial registration number: NCT05835622 https://clinicaltrials.gov/ct2/show/NCT05835622). Patient recruitment is currently underway and is anticipated to be completed by January 2026. Primary endpoint data collection is expected to be completed in June 2026.This study protocol describes a rigorous trial designed to provide high-level evidence on the impact of a home-based robotic exoskeleton on QoL in individuals with MS. By determining intervention effectiveness, the results will provide clinical guidelines, potentially facilitating the widespread adoption of home-based assistive robotics to substantially improve the independence and overall QoL for patients with MS. TRIAL REGISTRATION NUMBER: NCT05835622.
Indexed as
Identifiers
What OpenQuestion holds
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.