Evidence map›Paper›PMID 37567748›Full record

ArticleBMJ open2023

Exoskeletal wearable robot on ambulatory function in patients with stroke: a protocol for an international, multicentre, randomised controlled study.

Won Hyuk Chang, Tae-Woo Kim, Hyoung Seop Kim, Fazah Akhtar Hanapiah, Dae Hyun Kim, Deog Young Kim

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05157347 (Effect of Overground Gait Training Using a Torgue-Assisted Exoskeletal Wearable Device on Ambulatory Function in Subacute Stroke Patients, Multi-Center, Randomized Single-blinded Controlled Prospective Pilot Study), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
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.

NCT05157347 naunknown statusnot on this map

Effect of Overground Gait Training Using a Torgue-Assisted Exoskeletal Wearable Device on Ambulatory Function in Subacute Stroke Patients, Multi-Center, Randomized Single-blinded Controlled Prospective Pilot Study

TypeinterventionalSponsorYonsei UniversityRan2021 to 2023Enrolled150ConditionsSubacute StrokeArmsRobot-assisted Training, Conventional Therapy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Review
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

6 authors at 5 institutions in 2 countries.

Won Hyuk ChangDepartment of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).ORCID 0000-0002-4969-7895
Tae-Woo KimNational Traffic Injury Rehabilitation Hospital, Gyeonggi-do, Korea (the Republic of).
Hyoung Seop KimDepartment of Physical Medicine and Rehabilitation, National Health Insurance Service Ilsan Hospital, Goyang, Korea (the Republic of).
Fazah Akhtar HanapiahUniversiti Teknologi MARA, Shah Alam, Malaysia.
Dae Hyun KimDepartment of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).
Deog Young KimDepartment and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea (the Republic of) kimdy@yuhs.ac.
Yonsei University · KRNational Health Insurance Service Ilsan Hospital · KRNational Rehabilitation Center · KRSamsung Medical Center · KRUniversiti Teknologi MARA · MY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe purpose of this study is to determine the effect of overground gait training using an exoskeletal wearable robot (exoskeleton) on the recovery of ambulatory function in patients with subacute stroke. We also investigate the assistive effects of an exoskeleton on ambulatory function in patients with subacute stroke. METHODS AND ANALYSIS: This study is an international, multicentre, randomised controlled study at five institutions with a total of 150 patients with subacute stroke. Participants will be randomised into two groups (75 patients in the robot-assisted gait training (RAGT) group and 75 patients in the control group). The gait training will be performed with a total of 20 sessions (60 min/session); 5 sessions a week for 4 weeks. The RAGT group will receive 30 min of gait training using an exoskeleton (ANGEL LEGS M20, Angel Robotics) and 30 min of conventional gait training, while the control group will receive 60 min conventional gait training. In all the patients, the functional assessments such as ambulation, motor and balance will be evaluated before and after the intervention. Follow-up monitoring will be performed to verify whether the patient can walk without physical assistance for 3 months. The primary outcome is the improvement of the Functional Ambulatory Category after the gait training. The functional assessments will also be evaluated immediately after the last training session in the RAGT group to assess the assistive effects of an exoskeletal wearable robot. This trial will provide evidence on the effects of an exoskeleton to improve and assist ambulatory function in patients with subacute stroke. ETHICS AND DISSEMINATION: This protocol has been approved by the Institutional Review Board of each hospital and conforms to the Declaration of Helsinki. The results will be disseminated through publication. TRIAL REGISTRATION NUMBER: Protocol was registered at ClinicalTrials.gov (NCT05157347) on 15 December 2021 and CRIS (KCT0006815) on 19 November 2021.

Indexed as

Gait Disorders, NeurologicStrokeStroke RehabilitationWearable Electronic DevicesGaitHumansMulticenter Studies as TopicPhysical Therapy ModalitiesRandomized Controlled Trials as TopicWalkingProtocols & guidelinesREHABILITATION MEDICINEStroke

Identifiers

PMID37567748
PMCPMC10423773
OpenAlexW4385759798

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.