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The role of soft exosuit on walking function rehabilitation after stroke with fNIRS-based brain mechanism study

The role of soft exosuit on walking function rehabilitation after stroke with fNIRS-based brain mechanism study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088482
Enrollment
Unknown
Registered
2024-08-20
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Regular walking training group:Subjects were given routine walking training, which consisted of the following tasks: static and dynamic balance exercises, proprioception, and trunk control exercises
walking training with and without the use of assistive devices (canes, crutches, or walkers) on a double-bar or in a clinical open space
and training in walking up and down stairs. Each stroke subject received 10 sessions of regular walking training during the 2-week intervention, with each session lasting 30 minutes.
soft exosuit group:Subjects were given assisted walking training using a flexible exoskeleton, with each session lasting 30 minutes and consisting of the following motor tasks: proprioception, balance
stepping and relearning correct gait patterns
walking training in open spaces
and up and down stairs exercises. Each stroke subject received 10 sessions of flexible exoskeleton-assisted walking training during the 2-week intervention, with each session lasting 30 minutes.

Sponsors

Shanghai University of Traditional Chinese Medicine, School of Rehabilitation Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. ischaemic or haemorrhagic stroke confirmed by brain imaging and hemiparesis with walking impairment after the stroke; 2. 18-80 years of age, gender is not limited; 3. first onset of the disease with a duration of >3 months; 4. a Functional Ambulation Category (FAC) score of =1; 5. adequate passive ankle range of motion and passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., ability to achieve a 90° angle between the lower leg and foot); 6. an Ashworth spasticity rating of II or less in the lower extremity; 7. have sufficient cognitive functioning to perform the training tasks, with a score of =19 on the Brief Mental State Examination (MMSE), on top of which a patient with aphasia should have a score of =35 on the Auditory-Linguistic Comprehension portion of the Western Aphasia Battery (WAB), and a score of =10 on the Sequential Order portion of the WAB; 8. agree to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients with multiple strokes; 2. have received Botox within the last 6 months; 3. inability to communicate and/or be understood by the study staff; 4. resting heart rate outside the range of 50 to 100 beats per minute or blood pressure outside the range of 90/60 to 200/110 mmHg 5. pain in the extremities or spine that limits ambulation; and 6. the presence of serious comorbidities (including musculoskeletal, cardiac, and neuromuscular, skin, and vascular disorders); 7. more than two falls in the past month; 8. women who are pregnant or breastfeeding 9. those with pre-existing impairment of limb motor function prior to onset.

Design outcomes

Primary

MeasureTime frame
10-Meter Walk Test ;

Secondary

MeasureTime frame
lower extremity subscale of the Fugl-Meyer Assessment;Berg balance scale;Functional Ambulation Category;6-min walk test;Timed-Up-and-Go;Functional Near-infrared Spectroscopy data;Limits of Stability;

Countries

China

Contacts

Public ContactChunlei Shan

Shanghai University of Traditional Chinese Medicine, School of Rehabilitation Medicine; Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese Medicine

shanclhappy@163.com+86 138 1621 5058

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026